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A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00048568
Collaborator
(none)
1,250
Enrollment
48
Locations
3
Arms
82
Duration (Months)
26
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied.

Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Study Start Date :
Dec 1, 2002
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Abatacept + Methotrexate

Short Term: Abatacept was dosed by weight with participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. Participants continued treatment with methotrexate (MTX) either orally or parenterally at a minimum dose of 15 mg.

Drug: Abatacept
Intravenous (IV) Solution, - Weight Titered (500 mg < 60 kg); (750 mg 60-100 kg), )1 gram > 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
Other Names:
  • BMS-188667

    • Drug: Methotrexate
    Tablets, Oral, >= 15 mg, weekly, 1 year
    Other Names:
  • MTX

    		•
    Active Comparator: Placebo + Methotrexate

    Short Term: Participants received a placebo solution intravenously and methotrexate at the dose employed prior to study enrollment and a minimum of 15 mg.

    Drug: Methotrexate
    Tablets, Oral, >= 15 mg, weekly, 1 year
    Other Names:
  • MTX

    • Drug: Placebo
    IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
    Experimental: Abatacept + Methotrexate Open Label

    Open Label: Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.

    Drug: Abatacept
    Intravenous (IV) Solution, - Weight Titered (500 mg < 60 kg); (750 mg 60-100 kg), )1 gram > 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
    Other Names:
  • BMS-188667

    • Drug: Methotrexate
    Tablets, Oral, >= 15 mg, weekly, 1 year
    Other Names:
  • MTX

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169 [Day 169]

      ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.

    2. Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365 [Day 365]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    3. Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365 [BL (Day 0), Day 365]

      To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Change from baseline = Post-baseline - Baseline value

    4. Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period [Day 365 to Day 2,185]

      AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.

    5. Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period [Day 365 to Day 2,185]

      Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.

    6. Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period [Day 365 to Day 2,185]

      Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.

    7. Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period [Day 365 to Day 2,185]

      Sodium < 0.9 * LLN or > 1.05 * ULN or if BL < LLN then use < 0.95 * BL or > ULN or if BL > ULN then use >1.05 *BL or < LLN; Potassium: < 0.9 * LLN or > 1.1 * ULN or if BL < LLN then use < 0.9 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Chloride: < 0.9 * LLN or > 1.1 * ULN or if BL < LLN then use <0.9 * BL or >ULN or if BL > ULN then use > 1.1 * BL or < LLN; Calcium <0.8 * LLN or > 1.2 * ULN or if BL < LLN then use <0.67 * BL or > ULN or if BL > ULN then use > 1.3 * BL or < LLN.

    8. Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period [Day 365 to Day 2,185]

      Glucose: < 65 mg/dL or > 220 mg/dL; Fasting Glucose: <0.8 * LLN or > 1.5 * ULN or if BL < LLN then use < 0.8 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Total protein: < 0.9 * LLN or 1.1 * ULN or if BL < LLN then use 0.9 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Albumin: < 0.9 * LLN or if BL < LLN then use 0.75 * BL; Uric acid: > 1.5 * ULN or if BL > ULN then use > 2.0 * BL. All urinalysis abnormalities were defined as: if missing BL then use >= 2 or if value >=4, or if BL = 0 or 0.5 then use >= 2, or if BL = 1.0 then use >= 3, or if BL = 2.0 then use >=4.

    9. Mean BL Immunoglobulins Over Time in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093]

      Mean baseline values are those that are reported for each cohort at each time point on Day 365, Day 729, and Day 1,093.

    10. Mean Change From BL in Immunoglobulins in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093]

    11. Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period [Day 1 to Day 1,821]

      Participants with titers to abatacept in the DB and OL periods. Serum samples from abatacept-treated adult participants with active Rheumatoid Arthritis (RA) were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and or CTLA4-T.

    12. Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period [Day 365 to Day 1,821. All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing.]

      Vital signs included body temperature, heart rate, and seated blood pressure. Clinically significant changes were defined as those that were not within the normal range for the participant.

    13. Number of Participants Experiencing AEs of Special Interest in the OL Period [Day 365 to Day 2,185]

      AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest have been identified to be those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.

    14. Mean BL Hematocrit in the OL Period [Baseline (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.

    15. Mean Change From BL in Participant Hematocrit in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      All changes in participant laboratory parameters were monitored on each day of study drug administration.

    16. Mean BL Platelet Count in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.

    17. Mean Change From BL in Participant Platelet Count in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      All changes in participant laboratory parameters were monitored on each day of study drug administration.

    18. Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.

    19. Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      All changes in participant laboratory parameters were monitored on each day of study drug administration.

    20. Mean BL White Blood Cells in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.

    21. Mean Change From BL in White Blood Cells in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      All changes in participant laboratory parameters were monitored on each day of study drug administration.

    22. Mean BL Liver Function Parameters in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.

    23. Mean Change From BL in Liver Function Parameters in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      All changes in participant laboratory parameters were monitored on each day of study drug administration.

    24. Mean BL Select Laboratory Parameters in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.

    25. Mean Change From BL in Select Laboratory Parameters in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      All changes in participant laboratory parameters were monitored on each day of study drug administration.

    26. Mean BL Serum Electrolytes in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.

    27. Mean Change From BL in Serum Electrolytes in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]

      All changes in participant laboratory parameters were monitored on each day of study drug administration.

    Secondary Outcome Measures

    1. Mean Number of Tender Joints and Swollen Joints at DB BL [BL (Day 0)]

    2. Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment [BL (Day 0)]

      Participant physical pain assessment was determined at baseline on the Visual Analog Scale (VAS) of 0 mm to 100 mm where 0mm is no pain and 100mm is worst pain possible. The mean participant global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 100 mm. The physician global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 0mm to 100 mm with 0mm indicating no disease burden and 100mm indicating worse disease burden possible.

    3. BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period [BL (Day 365)]

      This analysis determined whether participants in the OL period were RF positive or RF negative based on serum samples. A positive value for RF was > 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.

    4. ACR 20 Responders at Day 365 [Day 365]

      ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.

    5. ACR 20 Responders in the Double-Blind (DB) Period [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]

      ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.

    6. ACR 50 Responders at Day 169 [Day 169]

      ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.

    7. ACR 50 Responders at Day 365 [Day 365]

      ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.

    8. ACR 50 Responders in the DB Period [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]

      ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.

    9. ACR 70 Responders at Day 169 [Day 169]

      ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.

    10. ACR 70 Responders at Day 365 [Day 365]

      ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.

    11. ACR 70 Responders in the DB Period [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]

      ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.

    12. Number of Participants Achieving Major Clinical Response By Day 365 [Day 1 to Day 365. Data were collected monthly during the first 6 months and then every other month (with the exception of Day 337) during the second 6 months of the DB period.]

      A Major Clinical Response (MCR) is defined as maintenance of an ACR 70 response over a continuous 6-month period.

    13. Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365 [BL (Day 0), Day 169, Day 365, Day 169, Day 365]

      The DAS 28 is an assessment of disease activity measured on a visual analog scale (VAS)of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (>5.1); low (≤3.2); remission (<2.6). Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    14. Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period [Day 1 to Day 365]

      AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.

    15. Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS) [BL (Day 0), Day 365]

      To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value.

    16. Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36) [BL (Day 0), Day 169, Day 365]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    17. Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period [BL (Day 0), Day 169, Day 365]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.

    18. Participants in the DB Period Achieving an Extended Major Clinical Response [Day 1 to Day 365]

      An extended major clinical response (MCR) was defined as a continuous ACR 70 response over any nine month treatment period with study medications. ACR 70 response criteria requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.

    19. Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period [BL (Day 0), Day 169, Day 365]

      The mean baseline CRP and ESR in the DB period on Day 169 and Day 365 was evaluated for all treated participants. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    20. Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period [BL (Day 0), Day 169, Day 365]

      The mean change from baseline in CRP and ESR in the DB period was evaluated for all treated participants. Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.

    21. Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period [BL (Day 0), Day 169, Day 365]

      The mean baseline sIL2-r in the DB period was evaluated from serum samples for all treated participants.

    22. Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period [BL (Day 0), Day 169, Day 365]

      The mean change from baseline in sIL2-r in the DB period was evaluated for all treated participants.

    23. ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]

      Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    24. ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]

      The mean number of swollen joints in the DB period was evaluated based on the swollen joint core component of the ACR scoring system where increasing score indicates increasing level of severity. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    25. ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]

      Participant self-reported pain assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.

    26. ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    27. ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]

      Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.

    28. ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]

      Physician global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing very good global RA assessment and 100mm representing very poor global RA assessment.

    29. ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]

      CRP core component of the ACR scoring system was evaluated from serum samples in which increasing levels indicate increasing level of disease.

    30. Number of Participants Discontinuing in the DB Period [Day 1 to Day 169, Day 170 to Day 365]

      Participants that discontinued treatment during the DB period for any reason were evaluated after 6 months and 1 year of treatment.

    31. Change From BL in Joint Narrowing Score (JSN), Erosion Score (ES), and Total Score (TS) by Category in the DB Period [BL (Day 0), Day 365]

      To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Improvement=decreases from BL, stable=same as BL, worsening=increases from BL.

    32. Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period [Day 1 to Day 365]

      All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing. Vital signs included body temperature, heart rate, and seated blood pressure. Clinical significance was defined as any change from baseline that resulted in a value outside the normal limits for the participant.

    33. Participants Experiencing AEs of Special Interest in the DB Period [Day 1 to Day 365]

      AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs were identified as those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.

    34. Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 [BL (Day 0), Day 169, Day 365]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    35. Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 [Day 169]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    36. Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 [Day 365]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    37. Number of Participants With Immunogenicity to Abatacept in the DB Period [Day 1 to Day 365]

      Participants with titers to abatacept in the DB period. Serum samples from abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and/or CTLA4-T.

    38. Number of New Tender Joints and Number of New Swollen Joints in the DB Period [Day 169, Day 365]

      Tender joints and swollen joints are core components of the ACR 20, 50, and 70. The incidences of new tender joints and new swollen joints were evaluated in the DB period after 6 months and 1 year of treatment.

    39. Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period [Day 169, Day 365]

    40. Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period [Day 1 to Day 365]

      Marked abnormality criteria were: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.

    41. Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period [Day 1 to Day 365]

      Marked abnormality criteria were: Aspartate Aminotransferase (AST) >3 * ULN or if BL > ULN then use >4 *BL; Alanine Aminotransferase (ALT) >3 * ULN or if BL > ULN then use > 4 * BL; Creatinine > 1.5 * BL.

    42. Mean BL ESR and CRP Levels in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185]

      Mean baseline values are reported for each cohort at each time point.

    43. Mean Change From BL in ESR in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185]

      Serum samples were evaluated from study participants to determine the mean change from baseline in ESR values.

    44. Participant RF Seroconversion in the OL Period [Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 2,185]

      This analysis determined participant RF status (positive or RF negative) based on serum samples at each specified timepoint. A positive value for RF was > 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.

    45. Number of ACR 20 Responders in the DB and OL Periods [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821]

      ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.

    46. Number of ACR 50 Responders in the DB and OL Periods [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821]

      ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score.

    47. Number of ACR 70 Responders in the DB and OL Periods [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821]

      ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.

    48. Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The DAS 28 is a continuous measure evaluating extent of disease activity in RA, and is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, erythrocyte sedimentation rate (ESR) and participant assessment of disease activity measure on a visual analog scale (VAS) of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (> 5.1); low (≤ 3.2); remission (< 2.6).

    49. Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period [BL(Day 0), Day 15, Day 29,Day 57,Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    50. Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period [BL(Day 0),Day 15,Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      Change from baseline in participant were calculated at all study visits in the DB and OL periods.

    51. Mean BL DAS-28 ESR Over Time in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    52. Mean Change From BL in DAS-28 ESR Over Time in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      Change from baseline in participant serum values of ESR were calculated at all study visits in the OL period.

    53. Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period [Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    54. BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period [BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821]

      Change from baseline in the Genant-modified Sharp erosion score, JSN, TS were evaluated for all participants at the end of the OL period. The total Genant-modified Sharp score (TS) ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145).Higher scores indicated more damage. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    55. Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    56. Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.

    57. Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    58. Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.

    59. Mean BL Physical Function Component of the SF-36 by Visit in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    60. Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.

    61. Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    62. Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.

    63. Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    64. Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.

    65. Mean BL General Health Component of the SF-36 by Visit in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    66. Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.

    67. Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    68. Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.

    69. Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    70. Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.

    71. Mean BL Vitality Component of the SF-36 by Visit in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    72. Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.

    73. Mean BL Mental Health Component of the SF-36 by Visit in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    74. Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.

    75. Mean BL Fatigue in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      Mean baseline values are reported for each cohort at each time point using the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    76. Mean Change From BL in Fatigue in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The mean change from baseline in fatigue was measured on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable.

    77. Mean BL Sleep Quality in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      Mean baseline values are reported for each cohort at each time point using the Medical Outcomes Study Sleep scale (MOS-sleep [assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.

    78. Mean Change From BL in Sleep Quality in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]

      The mean change from baseline in sleep quality was assessed on the Medical Outcomes Study Sleep scale (MOS-sleep [assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.

    79. Mean BL Limitations on Activities of Daily Living in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457]

      Mean baseline values are reported for each cohort at each time point. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    80. Mean Change From BL in Limitations on Activities of Daily Living in the OL Period [BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457]

      The mean change from baseline in limitations on activities of daily living in the OL period. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA.

    81. Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period [BL (Day 0), Day 169, Day 365]

      Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    82. Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period [BL (Day 0), Day 169, Day 365]

      The mean change from baseline in potential biomarkers of disease (IL-6, SIL-3R, and TNF-Alpha were determined for all participants.

    83. Mean Change From BL in RF in the DB Period [BL (Day 0), Day 169, Day 365]

      The mean change from baseline in participant rheumatoid factor was determined after 6 months and 1 year of treatment relative to baseline. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    84. Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period [BL (Day 0), Day 169, Day 365]

      Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.

    85. Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period [BL (Day 0), Day 169, Day 365]

      The mean change from basline in particpant biomarkers of RA disease (E-Selectin, SICAM-1, and MMP3) after 6 months and 1 year of treatment, relative to baseline, were evaluated.

    86. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 365]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    87. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period [BL (Day 0), Day 365]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    88. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 449]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    89. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period [BL (Day 0), Day 449]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    90. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 533]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    91. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period [BL (Day 0), Day 533]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    92. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 617]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    93. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period [BL (Day 0), Day 617]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    94. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 729]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    95. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period [BL (Day 0), Day 729]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    96. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 813]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    97. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period [BL (Day 0), Day 813]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    98. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 897]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    99. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period [BL (Day 0), Day 897]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    100. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 981]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    101. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period [BL (Day 0), Day 981]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    102. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 1,093]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    103. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period [BL (Day 0), Day 1,093]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    104. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 1,177]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    105. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period [BL (Day 0), Day 1,177]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    106. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 1,261]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    107. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period [BL (Day 0), Day 1,261]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    108. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 1,345]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    109. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period [BL (Day 0), Day 1,345]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    110. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 1,457]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    111. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period [BL (Day 0), Day 1,457]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    112. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 1,625]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    113. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period [BL (Day 0), Day 1,625]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    114. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 1,821]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    115. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period [BL (Day 0), Day 1,821]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    116. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 1,989]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    117. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period [BL (Day 0), Day 1,989]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    118. Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period [BL (Day 0), Day 2,185]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    119. Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period [BL (Day 0), Day 2,185]

      The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis of RA.

    • Participants must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Birmingham Alabama United States
    2 Local Institution Huntsville Alabama United States
    3 Local Institution Mobile Alabama United States
    4 Local Institution Phoenix Arizona United States
    5 Local Institution Scottsdale Arizona United States
    6 Local Institution Corona California United States
    7 Local Institution Irvine California United States
    8 Local Institution La Jolla California United States
    9 Local Institution Long Beach California United States
    10 Local Institution Rancho Mirage California United States
    11 Local Institution Aurora Colorado United States
    12 Local Institution Colorado Springs Colorado United States
    13 Local Institution Denver Colorado United States
    14 Local Institution Hamden Connecticut United States
    15 Local Institution Washington District of Columbia United States
    16 Local Institution Fort Lauderdale Florida United States
    17 Local Institution Gainsville Florida United States
    18 Local Institution Palm Harbor Florida United States
    19 Local Institution Sarasota Florida United States
    20 Local Institution St. Petersburg Florida United States
    21 Local Institution Chicago Illinois United States
    22 Local Institution Rockford Illinois United States
    23 Local Institution Wichita Kansas United States
    24 Local Institution Coeur d'Alene Maryland United States
    25 Local Institution Cumberland Maryland United States
    26 Local Institution Springfield Massachusetts United States
    27 Local Institution Duluth Minnesota United States
    28 Local Institution Lincoln Nebraska United States
    29 Local Institution New Brunswick New Jersey United States
    30 Local Institution Albuquerque New Mexico United States
    31 Local Institution Albany New York United States
    32 Local Institution Binghamton New York United States
    33 Local Institution Bronx New York United States
    34 Local Institution Mineola New York United States
    35 Local Institution New York New York United States
    36 Local Institution Syracuse New York United States
    37 Local Institution Wilmington North Carolina United States
    38 Local Institution Cincinnati Ohio United States
    39 Local Institution Oklahoma City Oklahoma United States
    40 Local Institution Duncansville Pennsylvania United States
    41 Local Institution Norristown Pennsylvania United States
    42 Local Institution Sellersville Pennsylvania United States
    43 Local Institution Willow Grove Pennsylvania United States
    44 Local Institution North Charleston South Carolina United States
    45 Local Institution Austin Texas United States
    46 Local Institution San Antonio Texas United States
    47 Local Institution Arlington Virginia United States
    48 Local Institution Milwaukee Wisconsin United States

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00048568
    Other Study ID Numbers:
    • IM101-102
    First Posted:
    Nov 13, 2002
    Last Update Posted:
    Dec 5, 2011
    Last Verified:
    Oct 1, 2011
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Methotrexate
    Abatacept

    Study Results

    Participant Flow

    Recruitment Details Participants in this evaluation were enrolled 116 sites worldwide: 31 sites in the United States; 32 sites in Europe, 13 sites in Canada; 4 sites in Australia; 7 sites in Argentina; 7 sites in Brazil; 7 sites in Mexico; 3 sites in Peru; 5 sites in South Africa; 3 sites in Taiwan; and 4 sites in Turkey.
    Pre-assignment Detail Of 1250 participants enrolled, 594 participants were not randomized (519 no longer met study criteria, 37 for unknown reasons, 33 withdrew consent, 3 lost to follow-up, 1 administrative reason by sponsor, and 1 adverse event). Four participants (2 per group) were randomized but never treated; 2 no longer met study criteria and 2 withdrew consent.
    Arm/Group Title Abatacept (ABA) + Methotrexate (MTX) DB MTX + Placebo DB ABA + MTX [Open-label (OL)]
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Period Title: Double-Blind Period Days 1 to 169
    STARTED 433 219 0
    COMPLETED 401 174 0
    NOT COMPLETED 32 45 0
    Period Title: Double-Blind Period Days 1 to 169
    STARTED 401 174 0
    COMPLETED 385 162 0
    NOT COMPLETED 16 12 0
    Period Title: Double-Blind Period Days 1 to 169
    STARTED 0 0 539
    COMPLETED 0 0 379
    NOT COMPLETED 0 0 160

    Baseline Characteristics

    Arm/Group Title ABA + MTX DB MTX + Placebo DB Total
    Arm/Group Description Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Total of all reporting groups
    Overall Participants 433 219 652
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    51.5
    (12.9)
    50.4
    (12.4)
    51.1
    (12.7)
    Sex: Female, Male (Count of Participants)
    Female
    96
    22.2%
    40
    18.3%
    136
    20.9%
    Male
    337
    77.8%
    179
    81.7%
    516
    79.1%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    3
    0.7%
    1
    0.5%
    4
    0.6%
    Asian
    18
    4.2%
    10
    4.6%
    28
    4.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    10
    2.3%
    4
    1.8%
    14
    2.1%
    White
    379
    87.5%
    193
    88.1%
    572
    87.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    23
    5.3%
    11
    5%
    34
    5.2%
    Duration of Rheumatoid Arthritis (RA) Disease (Number) [Number]
    <= 2 years
    99
    22.9%
    45
    20.5%
    144
    22.1%
    > 2 years to <= 5 years
    93
    21.5%
    46
    21%
    139
    21.3%
    > 5 years to <=10 years
    106
    24.5%
    54
    24.7%
    160
    24.5%
    > 10 years
    135
    31.2%
    74
    33.8%
    209
    32.1%

    Outcome Measures

    1. Primary Outcome
    Title Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169
    Description ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Number [Participants]
    288
    66.5%
    85
    38.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments The study had a 99% power to detect a difference of 20% in ACR 20 between the 2 groups at the 5% level.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Chi-squared, Corrected
    Comments
    Method of Estimation Estimation Parameter Estimated Difference
    Estimated Value 28.2
    Confidence Interval (2-Sided) 95%
    19.8 to 36.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response.
    2. Primary Outcome
    Title Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Number [Participants]
    270
    62.4%
    84
    38.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Based on the hierarchical testing procedure for the co-primary measures, the study had 98% power to detect 18% difference in HAQ response rate between the two arms at the 5% level.
    Method Chi-squared, Corrected
    Comments This model includes treatment as the main factor and baseline value as a covariate.
    Method of Estimation Estimation Parameter Estimated Difference
    Estimated Value 24.4
    Confidence Interval (2-Sided) 95%
    15.9 to 32.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving HAQ response at Day 365.
    3. Primary Outcome
    Title Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365
    Description To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Change from baseline = Post-baseline - Baseline value
    Time Frame BL (Day 0), Day 365

    Outcome Measure Data

    Analysis Population Description
    All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the compliance issues of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 391 195
    BL
    21.68
    (18.07)
    21.83
    (18.63)
    Mean Change From BL
    0.63
    (1.77)
    1.14
    (2.81)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.029
    Comments
    Method Nonparametric ANCOVA
    Comments The rank of the change from baseline=dependent variable, treatment=the main factor, rank of baseline value as covariate.
    4. Secondary Outcome
    Title Mean Number of Tender Joints and Swollen Joints at DB BL
    Description
    Time Frame BL (Day 0)

    Outcome Measure Data

    Analysis Population Description
    All randomized and treated participants in the DB period.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, subjects weighing 60 kg to 100 kg received 750 mg, and subjects weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 433 219
    Tender Joints
    31.0
    (13.2)
    32.3
    (13.6)
    Swollen Joints
    21.4
    (8.8)
    22.1
    (8.8)
    5. Secondary Outcome
    Title Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment
    Description Participant physical pain assessment was determined at baseline on the Visual Analog Scale (VAS) of 0 mm to 100 mm where 0mm is no pain and 100mm is worst pain possible. The mean participant global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 100 mm. The physician global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 0mm to 100 mm with 0mm indicating no disease burden and 100mm indicating worse disease burden possible.
    Time Frame BL (Day 0)

    Outcome Measure Data

    Analysis Population Description
    All randomized and treated participants in the DB period.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, subjects weighing 60 kg to 100 kg received 750 mg, and subjects weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 433 219
    Participant Physical Pain Assessment
    63.3
    (21.1)
    65.9
    (20.6)
    Participant Global Assessment
    62.7
    (21.2)
    62.8
    (21.6)
    Physician Global Assessment
    68.0
    (16.0)
    67.4
    (17.0)
    6. Secondary Outcome
    Title BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period
    Description This analysis determined whether participants in the OL period were RF positive or RF negative based on serum samples. A positive value for RF was > 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.
    Time Frame BL (Day 365)

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the DB period).
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    RF Negative
    42
    9.7%
    18
    8.2%
    RF Positive
    312
    72.1%
    130
    59.4%
    7. Secondary Outcome
    Title ACR 20 Responders at Day 365
    Description ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
    Time Frame Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Number [Participants]
    310
    71.6%
    85
    38.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Chi-squared, Corrected
    Comments
    Method of Estimation Estimation Parameter Estimated Difference
    Estimated Value 33.4
    Confidence Interval (2-Sided) 95%
    25.1 to 41.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response at Day 365.
    8. Secondary Outcome
    Title ACR 20 Responders in the Double-Blind (DB) Period
    Description ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Day 15
    97
    22.4%
    30
    13.7%
    Day 29
    155
    35.8%
    51
    23.3%
    Day 57
    237
    54.7%
    75
    34.2%
    Day 85
    262
    60.5%
    80
    36.5%
    Day 113
    283
    65.4%
    86
    39.3%
    Day 141
    291
    67.2%
    93
    42.5%
    Day 169
    288
    66.5%
    85
    38.8%
    Day 225
    318
    73.4%
    91
    41.6%
    Day 281
    312
    72.1%
    94
    42.9%
    Day 365
    310
    71.6%
    85
    38.8%
    9. Secondary Outcome
    Title ACR 50 Responders at Day 169
    Description ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Number [Participants]
    169
    39%
    36
    16.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Chi-squared, Corrected
    Comments
    Method of Estimation Estimation Parameter Estimated Difference
    Estimated Value 23.0
    Confidence Interval (2-Sided) 95%
    15.0 to 31.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 169.
    10. Secondary Outcome
    Title ACR 50 Responders at Day 365
    Description ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
    Time Frame Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Number [Participants]
    205
    47.3%
    39
    17.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Chi-squared, Corrected
    Comments
    Method of Estimation Estimation Parameter Estimated Difference
    Estimated Value 30.1
    Confidence Interval (2-Sided) 95%
    21.8 to 38.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 365.
    11. Secondary Outcome
    Title ACR 50 Responders in the DB Period
    Description ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Day 15
    12
    2.8%
    2
    0.9%
    Day 29
    36
    8.3%
    9
    4.1%
    Day 57
    87
    20.1%
    16
    7.3%
    Day 85
    135
    31.2%
    17
    7.8%
    Day 113
    148
    34.2%
    27
    12.3%
    Day 141
    162
    37.4%
    39
    17.8%
    Day 169
    169
    39%
    36
    16.4%
    Day 225
    197
    45.5%
    42
    19.2%
    Day 281
    200
    46.2%
    38
    17.4%
    Day 365
    205
    47.3%
    39
    17.8%
    12. Secondary Outcome
    Title ACR 70 Responders at Day 169
    Description ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Number [Participants]
    84
    19.4%
    14
    6.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Chi-squared, Corrected
    Comments
    Method of Estimation Estimation Parameter Estimated Difference
    Estimated Value 13.3
    Confidence Interval (2-Sided) 95%
    7.0 to 19.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA + MTX and MTX + PLA in the proportion of participants achieving ACR 70 response at Day 169.
    13. Secondary Outcome
    Title ACR 70 Responders at Day 365
    Description ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
    Time Frame Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Number [Participants]
    122
    28.2%
    13
    5.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Chi-squared, Corrected
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 22.7
    Confidence Interval (2-Sided) 95%
    15.6 to 29.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. Secondary Outcome
    Title ACR 70 Responders in the DB Period
    Description ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Day 15
    4
    0.9%
    1
    0.5%
    Day 29
    8
    1.8%
    2
    0.9%
    Day 57
    27
    6.2%
    6
    2.7%
    Day 85
    54
    12.5%
    7
    3.2%
    Day 113
    57
    13.2%
    12
    5.5%
    Day 141
    75
    17.3%
    12
    5.5%
    Day 169
    84
    19.4%
    14
    6.4%
    Day 225
    103
    23.8%
    16
    7.3%
    Day 281
    106
    24.5%
    19
    8.7%
    Day 365
    122
    28.2%
    13
    5.9%
    15. Secondary Outcome
    Title Number of Participants Achieving Major Clinical Response By Day 365
    Description A Major Clinical Response (MCR) is defined as maintenance of an ACR 70 response over a continuous 6-month period.
    Time Frame Day 1 to Day 365. Data were collected monthly during the first 6 months and then every other month (with the exception of Day 337) during the second 6 months of the DB period.

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Number [Participants]
    60
    13.9%
    4
    1.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Chi-squared, Corrected
    Comments
    Method of Estimation Estimation Parameter Estimated Difference
    Estimated Value 12.3
    Confidence Interval (2-Sided) 95%
    7.3 to 17.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving MCR.
    16. Secondary Outcome
    Title Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365
    Description The DAS 28 is an assessment of disease activity measured on a visual analog scale (VAS)of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (>5.1); low (≤3.2); remission (<2.6). Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 169, Day 365, Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    BL (Day 0) for Day 169 Cohort (n=366, 179)
    6.82
    (0.87)
    6.84
    (0.82)
    BL (Day 0) for Day 169 Cohort (n=366, 179)
    4.34
    (1.38)
    5.50
    (1.35)
    BL (Day 0) for Day 365 Cohort (n=375, 183)
    6.82
    (0.87)
    6.83
    (0.82)
    BL (Day 0) for Day 365 Cohort (n=375, 183)
    3.97
    (1.40)
    5.36
    (1.32)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Estimated Difference on Day 169
    Estimated Value -1.15
    Confidence Interval (2-Sided) 95%
    -1.38 to -0.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated difference between ABA + MTX and MTX + PLA on Day 169.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Estimated Difference on Day 365
    Estimated Value -1.39
    Confidence Interval (2-Sided) 95%
    -1.63 to -1.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated difference between ABA + MTX and MTX + PLA on Day 365.
    17. Secondary Outcome
    Title Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period
    Description AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
    Time Frame Day 1 to Day 365

    Outcome Measure Data

    Analysis Population Description
    All treated subjects in the DB period.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 433 219
    Deaths
    1
    0.2%
    1
    0.5%
    SAEs
    65
    15%
    26
    11.9%
    Related SAEs
    15
    3.5%
    1
    0.5%
    Discontinuations Due to SAEs
    10
    2.3%
    3
    1.4%
    AEs
    378
    87.3%
    184
    84%
    Related AEs
    214
    49.4%
    104
    47.5%
    Discontinued Due to AEs
    18
    4.2%
    4
    1.8%
    18. Secondary Outcome
    Title Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)
    Description To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value.
    Time Frame BL (Day 0), Day 365

    Outcome Measure Data

    Analysis Population Description
    All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 391 195
    Baseline Mean JSN
    22.79
    (20.16)
    23.02
    (20.36)
    Mean Change From Baseline JSN Day 365
    0.58
    (1.54)
    1.18
    (2.58)
    Baseline Mean TS
    44.47
    (37.33)
    44.85
    (37.72)
    Mean Change From Baseline TS Day 365
    1.21
    (2.94)
    2.32
    (5.04)
    19. Secondary Outcome
    Title Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36)
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    BL (Day 0) for Day 169 Cohort (n= 416, 207)
    30.49
    (7.18)
    30.61
    (7.42)
    BL (Day 0) for Day 365 Cohort (n=417, 207)
    30.51
    (7.17)
    30.62
    (7.42)
    20. Secondary Outcome
    Title Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.
    Time Frame BL (Day 0), Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Day 169 (n=416, 207)
    8.82
    (0.42)
    4.77
    (0.59)
    Day 365 (n=417, 207)
    9.12
    (0.43)
    4.97
    (0.61)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Adjusted Mean Difference at Day 169
    Estimated Value 4.06
    Confidence Interval (2-Sided) 95%
    2.64 to 5.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Adjusted Mean Difference at Day 365
    Estimated Value 4.15
    Confidence Interval (2-Sided) 95%
    2.69 to 5.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    21. Secondary Outcome
    Title Participants in the DB Period Achieving an Extended Major Clinical Response
    Description An extended major clinical response (MCR) was defined as a continuous ACR 70 response over any nine month treatment period with study medications. ACR 70 response criteria requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
    Time Frame Day 1 to Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Number [Participants]
    26
    6%
    1
    0.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA + MTX DB, MTX + Placebo DB
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method Chi-squared, Corrected
    Comments
    Method of Estimation Estimation Parameter Estimated Difference
    Estimated Value 5.7
    Confidence Interval (2-Sided) 95%
    2.4 to 9.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving extended MCR.
    22. Secondary Outcome
    Title Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period
    Description The mean baseline CRP and ESR in the DB period on Day 169 and Day 365 was evaluated for all treated participants. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    BL (Day 0) CRP for Day 169 Cohort (n=418, 211)
    6.37
    (0.83)
    6.36
    (0.82)
    BL (Day 0) ESR for Day 169 Cohort (n=418, 211)
    6.82
    (0.87)
    6.84
    (0.82)
    BL (Day 0) CRP for Day 365 Cohort (n=424, 212)
    6.38
    (0.83)
    6.35
    (0.82)
    BL (Day 0) ESR for Day 365 Cohort (n=424, 212)
    6.82
    (0.87)
    6.83
    (0.82)
    23. Secondary Outcome
    Title Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period
    Description The mean change from baseline in CRP and ESR in the DB period was evaluated for all treated participants. Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
    Time Frame BL (Day 0), Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    Due to the closure of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    DAS-28 CRP Day 169 (n=418, 211)
    -2.38
    (0.06)
    -1.29
    (0.09)
    DAS-28 ESR Day 169 (n=418, 211)
    -2.48
    (0.07)
    -1.33
    (0.10)
    DAS-28 CRP Day 365 (n=424, 212)
    -2.71
    (0.06)
    -1.41
    (0.09)
    DAS-28 ESR Day 365 (n=424, 212)
    -2.85
    (0.07)
    -1.46
    (0.10)
    24. Secondary Outcome
    Title Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period
    Description The mean baseline sIL2-r in the DB period was evaluated from serum samples for all treated participants.
    Time Frame BL (Day 0), Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    All treated subjects in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Day 169 (n=370, 171)
    1776.0
    (946.5)
    1603.0
    (933.1)
    Day 365 (n=235, 106)
    1674.0
    (835.1)
    1601.0
    (1076.0)
    25. Secondary Outcome
    Title Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period
    Description The mean change from baseline in sIL2-r in the DB period was evaluated for all treated participants.
    Time Frame BL (Day 0), Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    All treated subjects in the DB period.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Day 169 (n=370, 171)
    -519.00
    (23.72)
    -85.50
    (32.78)
    Day 365 (n=235, 106)
    -562.00
    (40.82)
    -290.00
    (87.97)
    26. Secondary Outcome
    Title ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period
    Description Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    BL (Day 0) for Day 15 Cohort (n=416, 210)
    25.19
    (14.62)
    27.93
    (14.27)
    BL (Day 0) for Day 29 Cohort (n=419, 211)
    21.14
    (14.69)
    24.11
    (14.97)
    BL (Day 0) for Day 57 Cohort (n=421, 210)
    16.70
    (14.06)
    21.41
    (14.15)
    BL (Day 0) for Day 85 Cohort (n=417, 208)
    14.84
    (13.98)
    20.58
    (15.61)
    BL (Day 0) for Day 113 Cohort (n=415, 210)
    13.55
    (13.35)
    19.83
    (15.29)
    BL (Day 0) for Day 141 Cohort (n=420, 211)
    12.59
    (13.39)
    19.78
    (15.74)
    BL (Day 0) for Day 169 Cohort (n=420, 211)
    11.69
    (12.37)
    18.70
    (15.42)
    BL (Day 0) for Day 225 Cohort (n=419, 212)
    10.42
    (12.04)
    18.22
    (15.46)
    BL (Day 0) for Day 281Cohort (n=419, 211)
    9.92
    (11.37)
    17.10
    (16.04)
    BL (Day 0) for Day 365 Cohort (n=424, 212)
    9.96
    (11.87)
    18.31
    (15.72)
    27. Secondary Outcome
    Title ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period
    Description The mean number of swollen joints in the DB period was evaluated based on the swollen joint core component of the ACR scoring system where increasing score indicates increasing level of severity. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    BL (Day 0) for Day 15 Cohort (n=416, 210)
    16.40
    (8.63)
    18.49
    (9.92)
    BL (Day 0) for Day 29 Cohort (n=419, 211)
    14.04
    (9.26)
    16.03
    (9.23)
    BL (Day 0) for Day 57 Cohort (n=421, 210)
    11.02
    (8.64)
    14.77
    (9.85)
    BL (Day 0) for Day 85 Cohort (n=417, 208)
    9.76
    (8.99)
    14.56
    (10.83)
    BL (Day 0) for Day 113 Cohort (n=415, 210)
    8.73
    (8.64)
    13.93
    (10.69)
    BL (Day 0) for Day 141 Cohort (n=420, 211)
    7.84
    (8.10)
    13.28
    (10.70)
    BL (Day 0) for Day 169 Cohort (n=420, 211)
    7.54
    (7.77)
    13.14
    (11.05)
    BL (Day 0) for Day 225 Cohort (n=419, 212)
    6.80
    (7.57)
    12.78
    (11.06)
    BL (Day 0) for Day 281 Cohort (n=419, 211)
    6.50
    (7.52)
    12.46
    (10.98)
    BL (Day 0) for Day 365 Cohort (n=424, 212)
    6.31
    (7.16)
    12.69
    (10.84)
    28. Secondary Outcome
    Title ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period
    Description Participant self-reported pain assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Day 15 (n=413, 210)
    52.39
    (22.85)
    60.08
    (21.90)
    Day 29 (n=418, 211)
    47.03
    (23.84)
    54.69
    (23.86)
    Day 57 (n=419, 209)
    40.34
    (24.29)
    50.11
    (25.16)
    Day 85 (n=417, 207)
    35.97
    (24.01)
    48.36
    (25.53)
    Day 113 (n=418, 210)
    34.31
    (23.61)
    48.60
    (26.99)
    Day 141 (n=420, 211)
    33.93
    (25.47)
    48.26
    (27.19)
    Day 169 (n=421, 211)
    32.69
    (24.32)
    49.21
    (27.13)
    Day 225 (n=418, 211)
    31.39
    (24.01)
    47.20
    (26.77)
    Day 281 (n=419, 210)
    31.06
    (24.58)
    46.18
    (27.23)
    Day 365 (n=424, 212)
    29.78
    (24.20)
    48.17
    (27.82)
    29. Secondary Outcome
    Title ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Day 15 (n=405, 206)
    1.51
    (0.64)
    1.58
    (0.56)
    Day 29 (n=406, 207)
    1.41
    (0.64)
    1.47
    (0.60)
    Day 57 (n=412, 205)
    1.29
    (0.65)
    1.42
    (0.63)
    Day 85 (n=407, 203)
    1.18
    (0.68)
    1.32
    (0.65)
    Day 113 (n=409, 206)
    1.16
    (0.67)
    1.35
    (0.68)
    Day 141 (n=411, 207)
    1.13
    (0.71)
    1.35
    (0.70)
    Day 169 (n=413, 207)
    1.11
    (0.70)
    1.31
    (0.69)
    Day 225 (n=409, 207)
    1.06
    (0.70)
    1.35
    (0.70)
    Day 281 (n=408, 207)
    1.05
    (0.70)
    1.31
    (0.68)
    Day 365 (n=415, 208)
    1.04
    (0.70)
    1.34
    (0.70)
    30. Secondary Outcome
    Title ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period
    Description Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Day 15 (n=413, 210)
    50.90
    (22.42)
    56.66
    (22.33)
    Day 29 (n=418, 211)
    45.26
    (22.72)
    53.11
    (22.81)
    Day 57 (n=419, 209)
    39.78
    (23.02)
    49.34
    (23.98)
    Day 85 (n=417, 207)
    35.07
    (23.37)
    46.82
    (24.71)
    Day 113 (n=418, 210)
    33.98
    (22.59)
    47.26
    (25.69)
    Day 141 (n=420, 211)
    33.52
    (24.06)
    47.52
    (26.57)
    Day 169 (n=421, 211)
    32.37
    (23.26)
    47.93
    (26.24)
    Day 225 (n=418, 210)
    30.63
    (22.48)
    46.06
    (26.21)
    Day 281 (n=419, 211)
    29.98
    (23.25)
    44.45
    (26.13)
    Day 365 (n=424, 212)
    28.95
    (23.60)
    45.62
    (26.92)
    31. Secondary Outcome
    Title ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period
    Description Physician global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing very good global RA assessment and 100mm representing very poor global RA assessment.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Day 15 (n=415, 209)
    52.79
    (19.24)
    56.68
    (18.93)
    Day 29 (n=418, 211)
    45.24
    (20.58)
    51.83
    (20.14)
    Day 57 (n=421, 210)
    35.89
    (19.84)
    45.21
    (22.61)
    Day 85 (n=416, 208)
    31.07
    (20.12)
    42.59
    (23.87)
    Day 113 (n=412, 209)
    29.01
    (20.40)
    42.20
    (24.72)
    Day 141 (n=420, 211)
    26.71
    (20.38)
    41.22
    (25.33)
    Day 169 (n=421, 211)
    25.44
    (19.65)
    41.75
    (25.79)
    Day 225 (n=418, 212)
    24.34
    (19.27)
    40.68
    (26.15)
    Day 281 (n=419, 210)
    23.33
    (19.09)
    38.76
    (26.70)
    Day 365 (n=424, 212)
    21.58
    (19.53)
    41.04
    (25.91)
    32. Secondary Outcome
    Title ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period
    Description CRP core component of the ACR scoring system was evaluated from serum samples in which increasing levels indicate increasing level of disease.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    Day 15 (n=401, 199)
    3.27
    (3.13)
    2.65
    (2.34)
    Day 29 (n=410, 208)
    1.94
    (1.99)
    2.65
    (2.48)
    Day 57 (n=416, 209)
    1.70
    (2.02)
    2.36
    (2.34)
    Day 85 (n=412, 203)
    1.53
    (1.97)
    2.53
    (2.39)
    Day 113 (n=417, 209)
    1.49
    (1.69)
    2.55
    (2.59)
    Day 141 (n=414, 209)
    1.27
    (1.52)
    2.48
    (2.61)
    Day 169 (n=420, 211)
    1.42
    (1.67)
    2.56
    (2.43)
    Day 225 (n=414, 212)
    1.30
    (1.55)
    2.46
    (2.70)
    Day 281 (n=412, 210)
    1.36
    (1.80)
    2.60
    (3.09)
    Day 365 (n=424, 212)
    1.27
    (1.63)
    2.41
    (2.58)
    33. Secondary Outcome
    Title Number of Participants Discontinuing in the DB Period
    Description Participants that discontinued treatment during the DB period for any reason were evaluated after 6 months and 1 year of treatment.
    Time Frame Day 1 to Day 169, Day 170 to Day 365

    Outcome Measure Data

    Analysis Population Description
    All randomized and treated participants in the DB period.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 433 219
    Day 1 to 169 Discontinuations (DC) - All Causes
    32
    7.4%
    45
    20.5%
    Day 1 to 169 DC Due to Lack of Efficacy
    11
    2.5%
    33
    15.1%
    Day 170 to Day 365 DC - All Causes
    16
    3.7%
    12
    5.5%
    Day 170 to Day 365 DC Due to Lack of Efficacy
    2
    0.5%
    7
    3.2%
    34. Secondary Outcome
    Title Change From BL in Joint Narrowing Score (JSN), Erosion Score (ES), and Total Score (TS) by Category in the DB Period
    Description To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Improvement=decreases from BL, stable=same as BL, worsening=increases from BL.
    Time Frame BL (Day 0), Day 365

    Outcome Measure Data

    Analysis Population Description
    This analysis was not completed.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 0 0
    35. Primary Outcome
    Title Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period
    Description AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
    Time Frame Day 365 to Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period.
    Arm/Group Title ABA + MTX OL
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 539
    Deaths
    17
    3.9%
    SAEs
    215
    49.7%
    Related SAEs
    60
    13.9%
    Discontinuations Due to SAEs
    36
    8.3%
    AEs
    518
    119.6%
    Related AEs
    323
    74.6%
    Discontinued Due to AEs
    49
    11.3%
    36. Primary Outcome
    Title Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
    Description Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.
    Time Frame Day 365 to Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period.
    Arm/Group Title ABA + MTX OL
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 536
    Low Hemoglobin (LLN 11.5 g/dL)
    21
    4.8%
    Low Hematocrit (LLN 34%)
    20
    4.6%
    Low Erythrocytes (LLN 38 x 10^6 c/µL)
    15
    3.5%
    Low Platelet Count (LLN 140 x 10^3 c/µL)
    9
    2.1%
    High Platelet Count (ULN 415 x 10^3 c/µL)
    4
    0.9%
    Low Leukocytes (LLN 4 x 10^3 c/µL)
    53
    12.2%
    High Leukocytes (ULN 10.5 x 10^3 c/µL)
    68
    15.7%
    Low Absolute Neutrophils (LLN 1.8 x 10^3 c/µL)
    14
    3.2%
    Low Absolute Lymphocytes (LLN 0.7 x 10^3 c/µL)
    109
    25.2%
    High Absolute Lymphocytes (ULN 4.5 x 10^3 c/µL)
    4
    0.9%
    High Absolute Monocytes (ULN 1.0 x 10^3 c/µL)
    9
    2.1%
    High Absolute Basophils (ULN 0.2 x 10^3 c/µL)
    3
    0.7%
    High Absolute Eosinophils (ULN 0.4 x 10^3 c/µL)
    49
    11.3%
    37. Primary Outcome
    Title Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period
    Description Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.
    Time Frame Day 365 to Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period.
    Arm/Group Title ABA + MTX OL
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 536
    High ALP (ULN 150 U/L)
    3
    0.7%
    High AST (ULN 40 U/L)
    14
    3.2%
    High ALT (ULN 55 U/L)
    20
    4.6%
    High GGT (ULN 65 U/L)
    36
    8.3%
    High Bilirubin (ULN 1.2 mg/dL)
    6
    1.4%
    High BUN (ULN 26 mg/dL)
    40
    9.2%
    High Creatinine (ULN 1.5 mg/dL)
    92
    21.2%
    38. Primary Outcome
    Title Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period
    Description Sodium < 0.9 * LLN or > 1.05 * ULN or if BL < LLN then use < 0.95 * BL or > ULN or if BL > ULN then use >1.05 *BL or < LLN; Potassium: < 0.9 * LLN or > 1.1 * ULN or if BL < LLN then use < 0.9 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Chloride: < 0.9 * LLN or > 1.1 * ULN or if BL < LLN then use <0.9 * BL or >ULN or if BL > ULN then use > 1.1 * BL or < LLN; Calcium <0.8 * LLN or > 1.2 * ULN or if BL < LLN then use <0.67 * BL or > ULN or if BL > ULN then use > 1.3 * BL or < LLN.
    Time Frame Day 365 to Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period.
    Arm/Group Title ABA + MTX OL
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 536
    Low Sodium (LLN 135 mmol/L)
    11
    2.5%
    High Sodium (ULN 148 mmol/L)
    2
    0.5%
    Low Potassium (LLN 3.5 mmol/L)
    11
    2.5%
    High Potassium (ULN 5.5 mmol/L)
    32
    7.4%
    Low Chloride (LLN 96 mmol/L)
    1
    0.2%
    High Chloride (ULN 109 mmol/L)
    0
    0%
    Low Calcium (LLN 8.5 mg/dL)
    0
    0%
    High Calcium (ULN 10.6 mg/dL)
    1
    0.2%
    Low Phosphorous (LLN 2.5 mg/dL)
    16
    3.7%
    High Phosphorous (ULN 5.6 mg/dL)
    8
    1.8%
    39. Primary Outcome
    Title Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
    Description Glucose: < 65 mg/dL or > 220 mg/dL; Fasting Glucose: <0.8 * LLN or > 1.5 * ULN or if BL < LLN then use < 0.8 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Total protein: < 0.9 * LLN or 1.1 * ULN or if BL < LLN then use 0.9 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Albumin: < 0.9 * LLN or if BL < LLN then use 0.75 * BL; Uric acid: > 1.5 * ULN or if BL > ULN then use > 2.0 * BL. All urinalysis abnormalities were defined as: if missing BL then use >= 2 or if value >=4, or if BL = 0 or 0.5 then use >= 2, or if BL = 1.0 then use >= 3, or if BL = 2.0 then use >=4.
    Time Frame Day 365 to Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period.
    Arm/Group Title ABA + MTX OL
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 536
    Low Serum Glucose (LLN 64 mg/dL)
    120
    27.7%
    High Serum Glucose (ULN 140 mg/dL)
    36
    8.3%
    Low Serum Fasting Glucose (LLN 65 mg/dL)
    25
    5.8%
    High Serum Fasting Glucose (ULN 109 mg/dL)
    22
    5.1%
    Low Total Protein (LLN 6 g/dL)
    11
    2.5%
    High Total Protein (ULN 8.5 g/dL)
    6
    1.4%
    Low Albumin (LLN 3.5 g/dL)
    15
    3.5%
    High Uric Acid (ULN 8.7 mg/dL)
    4
    0.9%
    High Urine Protein (ULN Trace)
    39
    9%
    High Urine Glucose (ULN Trace)
    39
    9%
    High Urine Ketones (ULN Positive)
    1
    0.2%
    High Urine Blood (ULN >=0)
    141
    32.6%
    High Urine Leukocyte Esterase (ULN >=0)
    35
    8.1%
    High Urine White Blood Count (ULN 12 hpf)
    232
    53.6%
    High Urine Red Blood Count (ULN 8 hpf)
    181
    41.8%
    40. Secondary Outcome
    Title Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period
    Description All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing. Vital signs included body temperature, heart rate, and seated blood pressure. Clinical significance was defined as any change from baseline that resulted in a value outside the normal limits for the participant.
    Time Frame Day 1 to Day 365

    Outcome Measure Data

    Analysis Population Description
    All randomized and treated participants.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 433 219
    Number [Participants]
    0
    0%
    0
    0%
    41. Secondary Outcome
    Title Participants Experiencing AEs of Special Interest in the DB Period
    Description AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs were identified as those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.
    Time Frame Day 1 to Day 365

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the DB period.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 433 219
    Infections/Infestations
    50
    11.5%
    12
    5.5%
    Neoplasms
    14
    3.2%
    9
    4.1%
    Autoimmune Disorders
    13
    3%
    2
    0.9%
    Acute Infusional AEs
    38
    8.8%
    9
    4.1%
    42. Secondary Outcome
    Title Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    HAQ DI Day 169 (n=373, 159)
    1.68
    (0.63)
    1.70
    (0.59)
    HAQ DI Day 365 (n=369, 160)
    1.68
    (0.63)
    1.70
    (0.58)
    Dressing and Grooming Day 169 (n=374, 159)
    1.48
    (0.75)
    1.48
    (0.73)
    Dressing and Grooming Day 365 (n=372, 160)
    1.47
    (0.75)
    1.49
    (0.73)
    Arising Day 169 (n=373, 159)
    1.42
    (0.83)
    1.45
    (0.79)
    Arising Day 365 (n=372, 160)
    1.42
    (0.82)
    1.46
    (0.78)
    Eating Day 169 (n=374, 159)
    1.63
    (0.97)
    1.67
    (0.84)
    Eating Day 365 (n=372, 160)
    1.63
    (0.97)
    1.68
    (0.84)
    Walking Day 169 (n=373, 158)
    1.40
    (0.83)
    1.36
    (0.78)
    Walking Day 365 (n=372, 158)
    1.40
    (0.83)
    1.37
    (0.78)
    Hygiene Day 169 (n=373, 159)
    1.93
    (0.90)
    1.91
    (0.89)
    Hygiene Day 365 (n=370, 160)
    1.93
    (0.90)
    1.91
    (0.89)
    Reaching Day 169 (n=373, 159)
    1.94
    (0.86)
    1.97
    (0.80)
    Reaching Day 365 (n=370, 160)
    1.94
    (0.86)
    1.97
    (0.80)
    Gripping Day 169 (n=374, 159)
    1.80
    (0.76)
    1.90
    (0.67)
    Gripping Day 365 (n=371, 160)
    1.80
    (0.76)
    1.90
    (0.67)
    Activities Day 169 (n=373, 159)
    1.87
    (0.79)
    1.86
    (0.82)
    Activities Day 365 (n=369, 160)
    1.87
    (0.79)
    1.86
    (0.82)
    43. Secondary Outcome
    Title Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    HAQ DI
    -0.62
    (0.03)
    -0.52
    (0.05)
    Dressing and Grooming
    -0.73
    (0.04)
    -0.55
    (0.05)
    Arising
    -0.69
    (0.03)
    -0.65
    (0.05)
    Eating
    -0.68
    (0.04)
    -0.48
    (0.06)
    Walking
    -0.58
    (0.04)
    -0.45
    (0.05)
    Hygiene
    -0.48
    (0.05)
    -0.40
    (0.07)
    Reaching
    -0.64
    (0.04)
    -0.52
    (0.06)
    Gripping
    -0.53
    (0.04)
    -0.43
    (0.06)
    Activities
    -0.57
    (0.04)
    -0.43
    (0.06)
    44. Secondary Outcome
    Title Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    HAQ DI
    -0.68
    (0.03)
    -0.51
    (0.06)
    Dressing and Grooming
    -0.78
    (0.04)
    -0.61
    (0.06)
    Arising
    -0.75
    (0.04)
    -0.58
    (0.05)
    Eating
    -0.81
    (0.04)
    -0.44
    (0.06)
    Walking
    -0.61
    (0.04)
    -0.50
    (0.06)
    Hygiene
    -0.53
    (0.05)
    -0.37
    (0.07)
    Reaching
    -0.70
    (0.04)
    -0.59
    (0.07)
    Gripping
    -0.65
    (0.04)
    -0.44
    (0.07)
    Activities
    -0.66
    (0.44)
    -0.47
    (0.07)
    45. Secondary Outcome
    Title Number of Participants With Immunogenicity to Abatacept in the DB Period
    Description Participants with titers to abatacept in the DB period. Serum samples from abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and/or CTLA4-T.
    Time Frame Day 1 to Day 365

    Outcome Measure Data

    Analysis Population Description
    Participants treated with abatacept in the DB period with at least one immunogenicity sample collected in the DB period.
    Arm/Group Title ABA + MTX DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the DB period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
    Measure Participants 406
    Number [Participants]
    6
    1.4%
    46. Secondary Outcome
    Title Number of New Tender Joints and Number of New Swollen Joints in the DB Period
    Description Tender joints and swollen joints are core components of the ACR 20, 50, and 70. The incidences of new tender joints and new swollen joints were evaluated in the DB period after 6 months and 1 year of treatment.
    Time Frame Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    These data were not summarized as it was determined that no meaningful information would be obtained.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 0 0
    47. Secondary Outcome
    Title Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period
    Description
    Time Frame Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    100% Reduction in New Tender Joints Day 169
    43
    9.9%
    9
    4.1%
    100% Reduction in New Swollen Joints Day 169
    59
    13.6%
    14
    6.4%
    100% Reduction in New Tender Joints Day 365
    67
    15.5%
    8
    3.7%
    100% Reduction in New Swollen Joints Day 365
    78
    18%
    9
    4.1%
    48. Secondary Outcome
    Title Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period
    Description Marked abnormality criteria were: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.
    Time Frame Day 1 to Day 365

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the DB period.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 433 219
    Low Hemoglobin (LLN 11.5 g/dL)
    7
    1.6%
    4
    1.8%
    Low Hematocrit (LLN 34%)
    4
    0.9%
    3
    1.4%
    Low Platelet Count (LLN 140 x 10^3 c/uL)
    4
    0.9%
    1
    0.5%
    High Platelet Count (ULN 415 x 10^3 c/uL)
    1
    0.2%
    0
    0%
    Low Leukocytes (LLN 4.0 x 10^3 c/uL)
    15
    3.5%
    4
    1.8%
    High Leukocytes (ULN 10.5 x 10^3 c/uL)
    45
    10.4%
    33
    15.1%
    Low Absolute Neutrophils (LLN 1.8 x 10^3 c/uL)
    10
    2.3%
    3
    1.4%
    49. Secondary Outcome
    Title Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period
    Description Marked abnormality criteria were: Aspartate Aminotransferase (AST) >3 * ULN or if BL > ULN then use >4 *BL; Alanine Aminotransferase (ALT) >3 * ULN or if BL > ULN then use > 4 * BL; Creatinine > 1.5 * BL.
    Time Frame Day 1 to Day 365

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the DB period.
    Arm/Group Title ABA + MTX DB Placebo + MTX DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 433 219
    High AST (ULN 40 U/L)
    4
    0.9%
    2
    0.9%
    High ALT (ULN 55 U/L)
    7
    1.6%
    5
    2.3%
    High Creatinine (ULN 1.5 mg/ dL)
    23
    5.3%
    15
    6.8%
    50. Secondary Outcome
    Title Mean BL ESR and CRP Levels in the OL Period
    Description Mean baseline values are reported for each cohort at each time point.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 378 161
    ESR Day 365 (n=343, 141)
    43.56
    (22.98)
    43.61
    (25.25)
    CRP Day 365 (n=373, 160)
    32.48
    (31.41)
    24.72
    (20.74)
    ESR Day 729 (n=307, 132)
    43.74
    (23.44)
    41.37
    (24.15)
    CRP Day 729 (n=348, 153)
    32.12
    (30.99)
    23.46
    (19.65)
    ESR Day 1,093 (n=283, 123)
    43.57
    (23.34)
    42.41
    (25.25)
    CRP Day 1,093 (n=306, 131)
    31.96
    (30.35)
    24.09
    (19.85)
    ESR Day 1,457 (n=270, 111)
    43.49
    (23.71)
    42.87
    (24.27)
    CRP Day 1,457 (n=295, 132)
    32.13
    (30.14)
    23.20
    (19.22)
    ESR Day 1,821 (n=257, 109)
    43.03
    (22.86)
    41.83
    (24.01)
    CRP Day 1,821 (n=275, 124)
    31.41
    (29.30)
    22.14
    (18.34)
    ESR Day 1,989 (n=114, 49)
    42.61
    (24.00)
    38.78
    (19.64)
    CRP Day 1,989 (n=128, 61)
    33.22
    (34.65)
    20.39
    (14.43)
    ESR Day 2,185 (n=76, 29)
    45.04
    (23.46)
    39.17
    (21.30)
    CRP Day 2,185 (n=83, 38)
    34.73
    (36.05)
    22.08
    (15.69)
    51. Secondary Outcome
    Title Mean Change From BL in ESR in the OL Period
    Description Serum samples were evaluated from study participants to determine the mean change from baseline in ESR values.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 378 161
    Day 365 (n=343, 141)
    -17.9
    (1.21)
    -6.85
    (1.74)
    Day 729 (n=307, 132)
    -19.3
    (1.29)
    -16.3
    (1.91)
    Day 1,093 (n=283, 123)
    -17.2
    (1.55)
    -16.6
    (2.15)
    Day 1,457 (n=270, 111)
    -17.7
    (1.41)
    -16.3
    (2.33)
    Day 1,821 (n=257, 109)
    -17.7
    (1.46)
    -16.6
    (2.26)
    Day 1,989 (n=114, 49)
    -17.3
    (2.33)
    -13.3
    (3.12)
    Day 2,185 (n=76, 29)
    -22.1
    (2.92)
    -21.0
    (4.45)
    52. Secondary Outcome
    Title Participant RF Seroconversion in the OL Period
    Description This analysis determined participant RF status (positive or RF negative) based on serum samples at each specified timepoint. A positive value for RF was > 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.
    Time Frame Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 378 161
    Positive Seroconversion Day 365 (n=347, 146)
    2
    0.5%
    3
    1.4%
    Negative Seroconversion Day 365 (n=347, 146)
    31
    7.2%
    2
    0.9%
    Positive Seroconversion Day 729 (n=330, 143)
    8
    1.8%
    1
    0.5%
    Negative Seroconversion Day 729 (n=330, 143)
    31
    7.2%
    10
    4.6%
    Positive Seroconversion Day 1,093 (n=280, 119)
    6
    1.4%
    3
    1.4%
    Negative Seroconversion Day 1,093 (n=280, 119)
    27
    6.2%
    7
    3.2%
    Positive Seroconversion Day 1,457 (n=275, 118)
    5
    1.2%
    4
    1.8%
    Negative Seroconversion Day 1,457 (n=275, 118)
    27
    6.2%
    8
    3.7%
    Positive Seroconversion Day 1,821 (n=255, 115)
    4
    0.9%
    5
    2.3%
    Negative Seroconversion Day 1,821 (n=255, 115)
    25
    5.8%
    9
    4.1%
    Positive Seroconversion Day 2,185 (n=75, 31)
    3
    0.7%
    3
    1.4%
    Negative Seroconversion Day 2,185 (n=75, 31)
    7
    1.6%
    2
    0.9%
    53. Secondary Outcome
    Title Number of ACR 20 Responders in the DB and OL Periods
    Description ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 15 (n = 370, n = 158)
    95
    21.9%
    26
    11.9%
    Day 29 (n = 368, n=158)
    145
    33.5%
    44
    20.1%
    Day 57 (n = 371, n = 159)
    218
    50.3%
    66
    30.1%
    Day 85 (n = 367, n = 158)
    246
    56.8%
    70
    32%
    Day 113 (n = 367, n = 159)
    266
    61.4%
    79
    36.1%
    Day 141 (n = 368, n = 159)
    275
    63.5%
    85
    38.8%
    Day 169 (n = 371, n = 159)
    272
    62.8%
    79
    36.1%
    Day 225 (n = 369, n = 158)
    302
    69.7%
    86
    39.3%
    Day 281 (n = 367, n = 159)
    299
    69.1%
    92
    42%
    Day 365 (n = 373, n = 159)
    307
    70.9%
    86
    39.3%
    Day 449 (n = 363, n = 155)
    299
    69.1%
    122
    55.7%
    Day 533 (n = 353, n = 155)
    300
    69.3%
    127
    58%
    Day 617 (n = 347, n = 155)
    299
    69.1%
    127
    58%
    Day 729 (n = 337, n = 147)
    296
    68.4%
    122
    55.7%
    Day 813 (n = 322, n = 143)
    273
    63%
    124
    56.6%
    Day 897 (n = 311, n = 136)
    260
    60%
    117
    53.4%
    Day 981 (n = 298, n = 133)
    243
    56.1%
    110
    50.2%
    Day 1,093 (n = 303, n = 134)
    257
    59.4%
    111
    50.7%
    Day 1,177 (n = 265, n = 117)
    228
    52.7%
    101
    46.1%
    Day 1,261 (n = 289, n = 131)
    251
    58%
    107
    48.9%
    Day 1,345 (n = 133, n = 53)
    108
    24.9%
    43
    19.6%
    Day 1,457 (n = 288, n = 128)
    253
    58.4%
    110
    50.2%
    Day 1,625 (n = 273, n= 126)
    236
    54.5%
    112
    51.1%
    Day 1,821 (n = 268, n = 123)
    224
    51.7%
    106
    48.4%
    Day 1,989 (n = 119, n = 54)
    103
    23.8%
    45
    20.5%
    Day 2,185 (n = 85, n = 37)
    72
    16.6%
    34
    15.5%
    54. Secondary Outcome
    Title Number of ACR 50 Responders in the DB and OL Periods
    Description ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 15 (n = 371, n = 160)
    12
    2.8%
    2
    0.9%
    Day 29 (n = 368, n=158)
    35
    8.1%
    8
    3.7%
    Day 57 (n = 373, n = 159)
    82
    18.9%
    15
    6.8%
    Day 85 (n = 367, n = 158)
    128
    29.6%
    16
    7.3%
    Day 113 (n = 368, n = 159)
    142
    32.8%
    25
    11.4%
    Day 141 (n = 371, n = 159)
    157
    36.3%
    38
    17.4%
    Day 169 (n = 373, n = 159)
    163
    37.6%
    35
    16%
    Day 225 (n = 370, n = 159)
    188
    43.4%
    42
    19.2%
    Day 281 (n = 369, n = 159)
    193
    44.6%
    38
    17.4%
    Day 365 (n = 372, n = 160)
    202
    46.7%
    40
    18.3%
    Day 449 (n = 366, n = 155)
    214
    49.4%
    70
    32%
    Day 533 (n = 348, n = 156)
    213
    49.2%
    82
    37.4%
    Day 617 (n = 346, n = 155)
    213
    49.2%
    87
    39.7%
    Day 729 (n = 338, n = 147)
    207
    47.8%
    93
    42.5%
    Day 813 (n = 321, n = 145)
    196
    45.3%
    85
    38.8%
    Day 897 (n = 314, n = 136)
    184
    42.5%
    78
    35.6%
    Day 981 (n = 302, n = 133)
    182
    42%
    79
    36.1%
    Day 1,093 (n = 306, n = 135)
    194
    44.8%
    77
    35.2%
    Day 1,177 (n = 266, n = 118)
    158
    36.5%
    64
    29.2%
    Day 1,261 (n = 289, n = 130)
    176
    40.6%
    76
    34.7%
    Day 1,345 (n = 141, n = 56)
    83
    19.2%
    31
    14.2%
    Day 1,457 (n = 288, n = 127)
    193
    44.6%
    75
    34.2%
    Day 1,625 (n = 274, n= 126)
    181
    41.8%
    84
    38.4%
    Day 1,821 (n = 270, n = 123)
    165
    38.1%
    75
    34.2%
    Day 1,989 (n = 121, n = 55)
    78
    18%
    33
    15.1%
    Day 2,185 (n = 83, n = 37)
    46
    10.6%
    22
    10%
    55. Secondary Outcome
    Title Number of ACR 70 Responders in the DB and OL Periods
    Description ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX MTX + Placebo
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 15 (n = 371, n = 160)
    4
    0.9%
    1
    0.5%
    Day 29 (n = 369, n=159)
    8
    1.8%
    2
    0.9%
    Day 57 (n = 374, n = 159)
    27
    6.2%
    6
    2.7%
    Day 85 (n = 370, n = 158)
    51
    11.8%
    7
    3.2%
    Day 113 (n = 371, n = 159)
    56
    12.9%
    10
    4.6%
    Day 141 (n = 371, n = 159)
    73
    16.9%
    12
    5.5%
    Day 169 (n = 374, n = 159)
    83
    19.2%
    14
    6.4%
    Day 225 (n = 369, n = 160)
    100
    23.1%
    16
    7.3%
    Day 281 (n = 372, n = 160)
    104
    24%
    20
    9.1%
    Day 365 (n = 374, n = 160)
    121
    27.9%
    14
    6.4%
    Day 449 (n = 367, n = 157)
    122
    28.2%
    33
    15.1%
    Day 533 (n = 350, n = 156)
    126
    29.1%
    47
    21.5%
    Day 617 (n = 347, n = 154)
    116
    26.8%
    51
    23.3%
    Day 729 (n = 340, n = 147)
    130
    30%
    49
    22.4%
    Day 813 (n = 325, n = 146)
    117
    27%
    42
    19.2%
    Day 897 (n = 314, n = 138)
    109
    25.2%
    40
    18.3%
    Day 981 (n = 306, n = 134)
    116
    26.8%
    39
    17.8%
    Day 1,093 (n = 309, n = 137)
    116
    26.8%
    44
    20.1%
    Day 1,177 (n = 265, n = 122)
    94
    21.7%
    40
    18.3%
    Day 1,261 (n = 289, n = 132)
    105
    24.2%
    45
    20.5%
    Day 1,345 (n = 139, n = 57)
    52
    12%
    18
    8.2%
    Day 1,457 (n = 288, n = 128)
    121
    27.9%
    47
    21.5%
    Day 1,625 (n = 278, n= 125)
    115
    26.6%
    50
    22.8%
    Day 1,821 (n = 270, n = 125)
    107
    24.7%
    46
    21%
    Day 1,989 (n = 119, n = 54)
    50
    11.5%
    22
    10%
    Day 2,185 (n = 83, n = 37)
    32
    7.4%
    14
    6.4%
    56. Secondary Outcome
    Title Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
    Description The DAS 28 is a continuous measure evaluating extent of disease activity in RA, and is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, erythrocyte sedimentation rate (ESR) and participant assessment of disease activity measure on a visual analog scale (VAS) of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (> 5.1); low (≤ 3.2); remission (< 2.6).
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Remission Day 15 (n = 355, n = 152)
    1
    0.2%
    0
    0%
    Low Disease Activity Day 15 (n=355, 152)
    5
    1.2%
    1
    0.5%
    Remission Day 29 (n = 362, n =157)
    8
    1.8%
    0
    0%
    Low Disease Activity Day 29 (n=362, 157)
    24
    5.5%
    2
    0.9%
    Remission Day 57 (n = 367, n = 156)
    19
    4.4%
    1
    0.5%
    Low Disease Activity Day 57 (n=367, 156)
    44
    10.2%
    7
    3.2%
    Remission Day 85 (n = 366, n = 152)
    39
    9%
    3
    1.4%
    Low Disease Activity Day 85 (n=366, 152)
    76
    17.6%
    16
    7.3%
    Remission Day 113 (n = 367, n = 159)
    39
    9%
    9
    4.1%
    Low Disease Activity Day 113 (n=367, 159)
    89
    20.6%
    20
    9.1%
    Remission Day 141 (n = 366, n = 158)
    57
    13.2%
    7
    3.2%
    Low Disease Activity Day 141 (n=366, 158)
    104
    24%
    20
    9.1%
    Remission Day 169 (n = 371, n = 159)
    63
    14.5%
    6
    2.7%
    Low Disease Activity Day 169 (n=371, 159)
    117
    27%
    19
    8.7%
    Remission Day 225 (n = 366, n = 158)
    75
    17.3%
    9
    4.1%
    Low Disease Activity Day 225 (n=366, 158)
    147
    33.9%
    21
    9.6%
    Remission Day 281 (n = 364, n = 159)
    89
    20.6%
    14
    6.4%
    Low Disease Activity Day 281 (n=364, 159)
    150
    34.6%
    33
    15.1%
    Remission Day 365 (n = 370, n = 159)
    94
    21.7%
    4
    1.8%
    Low Disease Activity Day 365 (n=370, 159)
    163
    37.6%
    19
    8.7%
    Remission Day 449 (n = 357, n = 150)
    100
    23.1%
    32
    14.6%
    Low Disease Activity Day 449 (n=357, 150)
    162
    37.4%
    55
    25.1%
    Remission Day 533 (n = 343, n = 150)
    101
    23.3%
    42
    19.2%
    Low Disease Activity Day 553 (n=343, 150)
    158
    36.5%
    61
    27.9%
    Remission Day 617 (n = 334, n = 153)
    100
    23.1%
    46
    21%
    Low Disease Activity Day 617 (n=334, 153)
    159
    36.7%
    74
    33.8%
    Remission Day 729 (n = 337, n = 148)
    97
    22.4%
    45
    20.5%
    Low Disease Activity Day 729 (n=337, 148)
    175
    40.4%
    77
    35.2%
    Remission Day 813 (n = 317, n = 143)
    97
    22.4%
    46
    21%
    Low Disease Activity Day 813 (n=317, 143)
    160
    37%
    72
    32.9%
    Remission Day 897 (n = 303, n = 135)
    91
    21%
    48
    21.9%
    Low Disease Activity Day 897 (n=303, 135)
    152
    35.1%
    70
    32%
    Remission Day 981 (n = 297, n = 133)
    102
    23.6%
    46
    21%
    Low Disease Activity Day 981 (n=297, 133)
    168
    38.8%
    72
    32.9%
    Remission Day 1,093 (n = 300, n = 129)
    112
    25.9%
    42
    19.2%
    Low Disease Activity Day 1,093 (n=300, 129)
    160
    37%
    77
    35.2%
    Remission Day 1,177 (n = 158, n = 71)
    55
    12.7%
    27
    12.3%
    Low Disease Activity Day 1,177 (n=158, 71)
    84
    19.4%
    42
    19.2%
    Remission Day 1,261 (n = 267, n = 119)
    91
    21%
    50
    22.8%
    Low Disease Activity Day 1,261 (n=267, 119)
    146
    33.7%
    70
    32%
    Remission Day 1,457 (n = 284, n = 129)
    111
    25.6%
    51
    23.3%
    Low Disease Activity Day 1,457 (n=284, 129)
    161
    37.2%
    79
    36.1%
    Remission Day 1,625 (n = 272, n= 124)
    96
    22.2%
    47
    21.5%
    Low Disease Activity Day 1,625 (n=272, 124)
    145
    33.5%
    71
    32.4%
    Remission Day 1,821 (n = 270, n = 124)
    89
    20.6%
    47
    21.5%
    Low Disease Activity Day 1,821 (n=270, 124)
    147
    33.9%
    73
    33.3%
    Remission Day 1,989 (n=118, 54)
    43
    9.9%
    21
    9.6%
    Low Disease Activity Day 1,989 (n=118, 54)
    65
    15%
    31
    14.2%
    Remission Day 2,185 (n=82, 37)
    25
    5.8%
    18
    8.2%
    Low Disease Activity Day 2,185 (n=82, 37)
    41
    9.5%
    22
    10%
    57. Secondary Outcome
    Title Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
    Description Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL(Day 0), Day 15, Day 29,Day 57,Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 15 Cohort (n=352, 150)
    6.36
    (0.81)
    6.32
    (0.81)
    BL (Day 0) for Day 29 Cohort (n=357, 154)
    6.36
    (0.81)
    6.35
    (0.81)
    BL (Day 0) for Day 57 Cohort (n=362, 153)
    6.36
    (0.81)
    6.35
    (0.79)
    BL (Day 0) for Day 85 Cohort (n=362, 149)
    6.35
    (0.81)
    6.33
    (0.81)
    BL (Day 0) for Day 113 Cohort (n=362, 149)
    6.35
    (0.81)
    6.34
    (0.81)
    BL (Day 0) for Day 141 Cohort (n=361, 155)
    6.34
    (0.80)
    6.33
    (0.82)
    BL (Day 0) for Day 169 Cohort (n=366, 156)
    6.35
    (0.80)
    6.34
    (0.80)
    BL (Day 0) for Day 225 Cohort (n=361, 155)
    6.35
    (0.81)
    6.33
    (0.81)
    BL (Day 0) for Day 281 Cohort (n=359, 156)
    6.35
    (0.81)
    6.33
    (0.81)
    BL (Day 0) for Day 365 Cohort (n=365, 156)
    6.36
    (0.81)
    6.33
    (0.81)
    BL (Day 0) for Day 449 Cohort (n=352, 147)
    6.37
    (0.81)
    6.34
    (0.81)
    BL (Day 0) for Day 533 Cohort (n=338, 147)
    6.38
    (0.81)
    6.35
    (0.80)
    BL (Day 0) for Day 617 Cohort (n=329, 150)
    6.37
    (0.80)
    6.35
    (0.81)
    BL (Day 0) for Day 729 Cohort (n=333, 145)
    6.37
    (0.81)
    6.36
    (0.83)
    BL (Day 0) for Day 813 Cohort (n=313, 140)
    6.39
    (0.82)
    6.37
    (0.82)
    BL (Day 0) for Day 897 Cohort (n=301, 133)
    6.38
    (0.83)
    6.37
    (0.83)
    BL (Day 0) for Day 981 Cohort (n=294, 131)
    6.39
    (0.82)
    6.37
    (0.83)
    BL (Day 0) for Day 1,093 Cohort (n=296, 127)
    6.37
    (0.83)
    6.37
    (0.84)
    BL (Day 0) for Day 1,177 Cohort (n=156, 70)
    6.43
    (0.85)
    6.38
    (0.86)
    BL (Day 0) for Day 1,261 Cohort (n=267, 117)
    6.39
    (0.80)
    6.34
    (0.85)
    BL (Day 0) for Day 1,457 Cohort (n=281, 126)
    6.40
    (0.82)
    6.35
    (0.81)
    BL (Day 0) for Day 1,625 Cohort (n=269, 121)
    6.39
    (0.81)
    6.40
    (0.77)
    BL (Day 0) for Day 1,821 Cohort (n=267, 122)
    6.39
    (0.81)
    6.33
    (0.76)
    BL (Day 0) for Day 1,989 Cohort (n=118, 53)
    6.53
    (0.77)
    6.49
    (0.75)
    BL (Day 0) for Day 2,185 Cohort (n=82, 36)
    6.41
    (0.77)
    6.38
    (0.82)
    58. Secondary Outcome
    Title Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
    Description Change from baseline in participant were calculated at all study visits in the DB and OL periods.
    Time Frame BL(Day 0),Day 15,Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 15 (n=352, 150)
    -0.83
    (0.04)
    -0.47
    (0.06)
    Day 29 (n=357, 154)
    -1.27
    (0.05)
    -0.87
    (0.08)
    Day 57 (n=362, 153)
    -1.80
    (0.06)
    -1.17
    (0.09)
    Day 85 (n=362, 149)
    -2.12
    (0.06)
    -1.37
    (0.10)
    Day 113 (n=362, 149)
    -2.30
    (0.06)
    -1.47
    (0.11)
    Day 141 (n=361, 155)
    -2.46
    (0.07)
    -1.52
    (0.11)
    Day 169 (n=366, 156)
    -2.48
    (0.07)
    -1.57
    (0.11)
    Day 225 (n=361, 155)
    -2.72
    (0.07)
    -1.70
    (0.11)
    Day 281 (n=359, 156)
    -2.81
    (0.07)
    -1.87
    (0.10)
    Day 365 (n=365, 156)
    -2.83
    (0.07)
    -1.68
    (0.10)
    Day 449 (n=352, 147)
    -2.91
    (0.07)
    -2.68
    (0.10)
    Day 533 (n=338, 147)
    -3.01
    (0.07)
    -2.79
    (0.11)
    Day 617 (n=329, 150)
    -3.00
    (0.07)
    -2.92
    (0.11)
    Day 729 (n=333, 145)
    -3.10
    (0.07)
    -3.02
    (0.11)
    Day 813 (n=313, 140)
    -3.09
    (0.07)
    -3.05
    (0.12)
    Day 897 (n=301, 133)
    -3.06
    (0.07)
    -3.11
    (0.11)
    Day 981 (n=294, 131)
    -3.21
    (0.08)
    -3.14
    (0.12)
    Day 1,093 (n=296, 127)
    -3.21
    (0.08)
    -3.15
    (0.12)
    Day 1,177 (n=156, 70)
    -3.27
    (0.11)
    -3.21
    (0.16)
    Day 1,261 (n=267, 117)
    -3.22
    (0.08)
    -3.15
    (0.13)
    Day 1,457 (n=281, 126)
    -3.29
    (0.08)
    -3.23
    (0.11)
    Day 1,625 (n=269, 121)
    -3.23
    (0.08)
    -3.34
    (0.11)
    Day 1,821 (n=267, 122)
    -3.14
    (0.08)
    -3.26
    (0.12)
    Day 1,989 (n=118, 53)
    -3.39
    (0.12)
    -3.31
    (0.19)
    Day 2,185 (n=82, 36)
    -3.04
    (0.16)
    -3.30
    (0.23)
    59. Secondary Outcome
    Title Mean BL DAS-28 ESR Over Time in the OL Period
    Description Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n=352, 148)
    6.82
    (0.85)
    6.88
    (0.85)
    BL (Day 0) for Day 449 Cohort (n=345, 145)
    6.82
    (0.86)
    6.89
    (0.85)
    BL (Day 0) for Day 533 Cohort (n=332, 146)
    6.83
    (0.86)
    6.88
    (0.86)
    BL (Day 0) for Day 617 Cohort (n=325, 148)
    6.85
    (0.86)
    6.86
    (0.86)
    BL (Day 0) for Day 729 Cohort (n=315, 139)
    6.82
    (0.88)
    6.87
    (0.88)
    BL (Day 0) for Day 813 Cohort (n=303, 134)
    6.82
    (0.87)
    6.90
    (0.88)
    BL (Day 0) for Day 897 Cohort (n=296, 128)
    6.83
    (0.88)
    6.85
    (0.90)
    BL (Day 0) for Day 981 Cohort (n=282, 119)
    6.82
    (0.87)
    6.88
    (0.88)
    BL (Day 0) for Day 1,093 Cohort (n=287, 130)
    6.83
    (0.88)
    6.87
    (0.89)
    BL (Day 0) for Day 1,177 Cohort (n=241, 110)
    6.86
    (0.87)
    6.89
    (0.92)
    BL (Day 0) for Day 1,261 Cohort (n=271, 121)
    6.82
    (0.87)
    6.86
    (0.89)
    BL (Day 0) for Day 1,457 Cohort (n=269, 117)
    6.87
    (0.85)
    6.88
    (0.87)
    BL (Day 0) for Day 1,625 Cohort (n=260, 118)
    6.86
    (0.85)
    6.86
    (0.86)
    BL (Day 0) for Day 1,821 Cohort (n=259, 114)
    6.85
    (0.86)
    6.87
    (0.84)
    BL (Day 0) for Day 1,989 Cohort (n=108, 47)
    6.95
    (0.83)
    7.04
    (0.85)
    BL (Day 0) for Day 2,185 Cohort (n=76, 31)
    6.90
    (0.82)
    6.97
    (0.92)
    60. Secondary Outcome
    Title Mean Change From BL in DAS-28 ESR Over Time in the OL Period
    Description Change from baseline in participant serum values of ESR were calculated at all study visits in the OL period.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n=352, 148)
    -2.96
    (0.07)
    -1.76
    (0.11)
    Day 449 (n=345, 145)
    -3.04
    (0.08)
    -2.87
    (0.11)
    Day 533 (n=332, 146)
    -3.14
    (0.08)
    -2.95
    (0.12)
    Day 617 (n=325, 148)
    -3.17
    (0.08)
    -3.02
    (0.11)
    Day 729 (n=315, 139)
    -3.27
    (0.07)
    -3.20
    (0.12)
    Day 813 (n=303, 134)
    -3.13
    (0.08)
    -3.18
    (0.12)
    Day 897 (n=296, 128)
    -3.11
    (0.08)
    -3.10
    (0.12)
    Day 981 (n=282, 119)
    -3.26
    (0.09)
    -3.19
    (0.14)
    Day 1,093 (n=287, 130)
    -3.23
    (0.08)
    -3.22
    (0.13)
    Day 1,177 (n=241, 110)
    -3.33
    (0.09)
    -3.29
    (0.15)
    Day 1,261 (n=271, 121)
    -3.25
    (0.08)
    -3.18
    (0.14)
    Day 1,457 (n=269, 117)
    -3.32
    (0.08)
    -3.23
    (0.12)
    Day 1,625 (n=260, 118)
    -3.30
    (0.09)
    -3.27
    (0.12)
    Day 1,821 (n=259, 114)
    -3.22
    (0.09)
    -3.34
    (0.12)
    Day 1,989 (n=108, 47)
    -3.41
    (0.13)
    -3.42
    (0.23)
    Day 2,185 (n=76, 31)
    -3.25
    (0.17)
    -3.66
    (0.33)
    61. Primary Outcome
    Title Mean BL Immunoglobulins Over Time in the OL Period
    Description Mean baseline values are those that are reported for each cohort at each time point on Day 365, Day 729, and Day 1,093.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).
    Arm/Group Title ABA + MTX DB Placebo + MTX DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    Immunoglobulin A (IgA) Day 365
    327.0
    (135.2)
    319.2
    (145.1)
    Immunoglobulin G (IgG) Day 365
    1278
    (412.4)
    1317
    (425.4)
    Immunoglobulin M (IgM) Day 365
    145.1
    (86.72)
    154.3
    (85.53)
    IgA Day 729
    328.0
    (133.8)
    317.0
    (145.0)
    IgG Day 729
    1280
    (410.4)
    1315
    (425.3)
    IgM Day 729
    146.2
    (87.34)
    153.1
    (85.80)
    IgA Day 1,093
    321.8
    (133.4)
    318.5
    (145.7)
    IgG Day 1,093
    1273
    (392.3)
    1319
    (436.8)
    IgM Day 1,093
    148.6
    (91.01)
    153.5
    (88.82)
    62. Primary Outcome
    Title Mean Change From BL in Immunoglobulins in the OL Period
    Description
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).
    Arm/Group Title ABA + MTX DB Placebo + MTX DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    IgA Day 365
    -47.8
    (3.16)
    -8.30
    (6.41)
    IgG Day 365
    -212
    (12.77)
    -52.7
    (18.96)
    IgM Day 365
    -5.05
    (1.98)
    6.95
    (9.73)
    IgA Day 729
    -38.6
    (4.24)
    -26.6
    (9.95)
    IgG Day 729
    -215
    (14.10)
    -206
    (21.86)
    IgM Day 729
    8.04
    (3.96)
    6.49
    (5.76)
    IgA Day 1,093
    -46.8
    (4.76)
    -37.9
    (9.66)
    IgG Day 1,093
    -236
    (15.94)
    -245
    (25.44)
    IgM Day 1,093
    4.38
    (3.19)
    6.01
    (5.01)
    63. Primary Outcome
    Title Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period
    Description Participants with titers to abatacept in the DB and OL periods. Serum samples from abatacept-treated adult participants with active Rheumatoid Arthritis (RA) were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and or CTLA4-T.
    Time Frame Day 1 to Day 1,821

    Outcome Measure Data

    Analysis Population Description
    Participants with serum samples available for evaluation of titers to abatacept.
    Arm/Group Title ABA + MTX Cumulative DB + OL Periods
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the DB and OL periods under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 586
    Number [Participants]
    56
    12.9%
    64. Secondary Outcome
    Title Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 15 (n = 367, n = 160)
    115
    26.6%
    46
    21%
    Day 29 (n = 365, n = 159)
    148
    34.2%
    57
    26%
    Day 57 (n = 372, n = 157)
    199
    46%
    73
    33.3%
    Day 85 (n = 366, n = 156)
    228
    52.7%
    76
    34.7%
    Day 113 (n = 369, n = 159)
    239
    55.2%
    85
    38.8%
    Day 141 (n = 370, n = 159)
    238
    55%
    85
    38.8%
    Day 169 (n = 373, n = 159)
    247
    57%
    89
    40.6%
    Day 225 (n = 368, n = 159)
    252
    58.2%
    87
    39.7%
    Day 281 (n = 368, n = 160)
    249
    57.5%
    89
    40.6%
    Day 365 (n = 369, n = 160)
    265
    61.2%
    86
    39.3%
    Day 449 (n = 366, n = 157)
    268
    61.9%
    114
    52.1%
    Day 533 (n = 354, n = 157)
    259
    59.8%
    109
    49.8%
    Day 617 (n = 348, n = 154)
    257
    59.4%
    107
    48.9%
    Day 729 (n = 337, n = 148)
    248
    57.3%
    100
    45.7%
    Day 813 (n = 325, n= 146)
    237
    54.7%
    98
    44.7%
    Day 897 (n = 318, n = 140)
    232
    53.6%
    99
    45.2%
    Day 981 (n = 312, n = 137)
    227
    52.4%
    91
    41.6%
    Day 1,093 (n = 308, n = 137)
    225
    52%
    94
    42.9%
    Day 1,177 (n = 274, n = 124)
    205
    47.3%
    85
    38.8%
    Day 1,261 (n = 292, n = 134)
    214
    49.4%
    88
    40.2%
    Day 1,345 (n = 152, n = 62)
    106
    24.5%
    40
    18.3%
    Day 1,457 (n = 289, n = 129)
    218
    50.3%
    94
    42.9%
    Day 1,625 (n =280, n = 126)
    210
    48.5%
    92
    42%
    Day 1,821 (n = 271, n = 125)
    201
    46.4%
    90
    41.1%
    Day 1,989 (n = 119, n = 55)
    90
    20.8%
    35
    16%
    Day 2,185 (n = 85, n = 38)
    63
    14.5%
    26
    11.9%
    65. Secondary Outcome
    Title BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
    Description Change from baseline in the Genant-modified Sharp erosion score, JSN, TS were evaluated for all participants at the end of the OL period. The total Genant-modified Sharp score (TS) ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145).Higher scores indicated more damage. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort Erosion (n=291, 131)
    17.65
    (15.81)
    18.69
    (17.12)
    Day 365 Erosion Change From BL (n=291, 131)
    0.42
    (1.20)
    0.84
    (1.93)
    BL (Day 0) for Day 365 Cohort JSN (n=291, 131)
    10.83
    (14.02)
    12.02
    (14.53)
    Day 365 JSN Change From BL(n=291, 131)
    0.38
    (1.05)
    0.64
    (1.67)
    BL (Day 0) for Day 365 Cohort TS (n=291, 131)
    28.48
    (29.01)
    30.71
    (30.84)
    Day 365 TS Change From BL (n=291, 131)
    0.80
    (1.99)
    1.48
    (3.35)
    BL (Day 0) for Day 729 Cohort Erosion (n=290, 130)
    17.40
    (15.41)
    18.88
    (17.18)
    Day 729 Erosion Change From BL (n=291, 131)
    0.59
    (1.67)
    1.14
    (2.74)
    BL (Day 0) for Day 729 Cohort JSN (n=291, 131)
    10.65
    (13.80)
    12.21
    (14.56)
    Day 729 JSN Change From BL(n=291, 131)
    0.55
    (1.40)
    1.05
    (2.79)
    BL (Day 0) for Day 729 Cohort TS (n=291, 131)
    28.05
    (28.41)
    31.09
    (30.93)
    Day 729 TS Change From BL(n=291, 131)
    1.14
    (2.69)
    2.19
    (5.22)
    BL (Day 0) for Day 1093 Cohort Erosion (n=293,130)
    17.66
    (15.78)
    18.69
    (17.12)
    Day 1093 Erosion Change From BL (n=293, 130)
    0.92
    (2.60)
    1.48
    (3.65)
    BL (Day 0) for Day 1093 Cohort JSN (n=293, 130)
    10.84
    (13.97)
    12.02
    (14.53)
    Day 1093 JSN Change From BL (n=293, 130)
    0.73
    (2.02)
    1.31
    (3.40)
    BL (Day 0) for Day 1093 Cohort TS (n=293, 130)
    28.50
    (28.94)
    30.71
    (30.84)
    Day 1093 Total Score Change From BL (n=293, 130)
    1.65
    (4.20)
    2.79
    (6.60)
    BL (Day 0) for Day 1457 Cohort Erosion (n=290,128)
    17.46
    (15.46)
    18.94
    (17.30)
    Day 1457 Erosion Change From BL (n=290, 128)
    1.16
    (3.14)
    1.76
    (4.30)
    BL (Day 0) for Day 1457 Cohort JSN (n=290, 128)
    10.66
    (13.71)
    12.12
    (14.64)
    Day 1457 JSN Change From BL (n=290, 128)
    0.85
    (2.30)
    1.51
    (3.73)
    BL (Day 0) for Day 1457 Cohort TS (n=290, 128)
    28.12
    (28.35)
    31.06
    (31.16)
    Day 1457 TS Change From BL (n=290, 128)
    2.01
    (5.00)
    3.27
    (7.55)
    BL (Day 0) for Day 1821 Cohort Erosion (n=233,114)
    17.62
    (15.62)
    18.93
    (17.37)
    Day 1821 Erosion Change From BL (n=233, 114)
    1.12
    (2.99)
    2.05
    (4.88)
    BL (Day 0) for Day 1821 Cohort JSN (n=233, 114)
    10.77
    (13.73)
    12.01
    (14.47)
    Day 1821 JSN Change From BL (n=233, 114)
    0.90
    (2.54)
    1.73
    (4.11)
    BL (Day 0) for Day 1821 Cohort TS (n=233, 114)
    28.39
    (28.50)
    30.94
    (30.99)
    Day 1821 TS Change From BL (n=233, 114)
    2.02
    (4.93)
    3.78
    (8.46)
    66. Secondary Outcome
    Title Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n=370, 157)
    30.69
    (6.84)
    30.94
    (7.32)
    BL (Day 0) for Day 449 Cohort (n=362, 156)
    30.55
    (6.78)
    30.95
    (7.34)
    BL (Day 0) for Day 533 Cohort (n=355, 155)
    30.64
    (6.79)
    30.86
    (7.34)
    BL (Day 0) for Day 617 Cohort (n=348, 153)
    30.70
    (6.81)
    30.88
    (7.37)
    BL (Day 0) for Day 729 Cohort (n=338, 146)
    30.75
    (6.78)
    30.88
    (7.25)
    BL (Day 0) for Day 813 Cohort (n=323, 145)
    30.58
    (6.66)
    31.00
    (7.29)
    BL (Day 0) for Day 897 Cohort (n=320, 139)
    30.52
    (6.69)
    30.87
    (7.41)
    BL (Day 0) for Day 981 Cohort (n=312, 136)
    30.49
    (6.64)
    30.98
    (7.46)
    BL (Day 0) for Day 1,093 Cohort (n=308, 137)
    30.51
    (6.67)
    30.93
    (7.45)
    BL (Day 0) for Day 1,177 Cohort (n=273, 124)
    30.58
    (6.78)
    30.87
    (7.19)
    BL (Day 0) for Day 1,261 Cohort (n=289, 133)
    30.64
    (6.86)
    31.02
    (7.47)
    BL (Day 0) for Day 1,345 Cohort (n=146, 60)
    30.40
    (6.32)
    29.37
    (7.07)
    BL (Day 0) for Day 1,457 Cohort (n=288, 128)
    30.51
    (6.76)
    31.23
    (7.46)
    BL (Day 0) for Day 1,625 Cohort (n=278, 125)
    30.70
    (6.78)
    30.90
    (7.30)
    BL (Day 0) for Day 1,821 Cohort (n=273, 124)
    30.54
    (6.81)
    31.27
    (7.42)
    BL (Day 0) for Day 1,989 Cohort (n=118, 54)
    29.80
    (6.72)
    30.66
    (7.61)
    BL (Day 0) for Day 2,185 Cohort (n=84, 38)
    28.80
    (5.77)
    29.74
    (5.72)
    67. Secondary Outcome
    Title Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n=370, 157)
    9.70
    (0.50)
    6.61
    (0.74)
    Day 449 (n=362, 156)
    10.51
    (0.50)
    9.91
    (0.78)
    Day 533 (n=355, 155)
    10.27
    (0.51)
    10.53
    (0.86)
    Day 617 (n=348, 153)
    10.46
    (0.52)
    10.74
    (0.85)
    Day 729 (n=338, 146)
    10.71
    (0.53)
    10.36
    (0.84)
    Day 813 (n=323, 145)
    10.79
    (0.55)
    10.41
    (0.84)
    Day 897 (n=320, 139)
    10.30
    (0.53)
    9.87
    (0.85)
    Day 981 (n=312, 136)
    11.05
    (0.58)
    10.78
    (0.87)
    Day 1,093 (n=308, 137)
    10.83
    (0.55)
    11.07
    (0.94)
    Day 1,177 (n=273, 124)
    11.02
    (0.61)
    11.20
    (1.01)
    Day 1,261 (n=289, 133)
    10.40
    (0.60)
    11.34
    (0.94)
    Day 1,345 (n=146, 60)
    9.81
    (0.87)
    10.81
    (1.55)
    Day 1,457 (n=288, 128)
    11.12
    (0.58)
    10.68
    (0.97)
    Day 1,625 (n=278, 125)
    10.76
    (0.61)
    11.05
    (0.90)
    Day 1,821 (n=273, 124)
    10.81
    (0.63)
    10.09
    (0.91)
    Day 1,989 (n=118, 54)
    11.69
    (0.93)
    9.65
    (1.47)
    Day 2,185 (n=84, 38)
    9.69
    (0.99)
    11.39
    (1.71)
    68. Secondary Outcome
    Title Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n=370, 157)
    41.40
    (11.35)
    40.56
    (11.18)
    BL (Day 0) for Day 449 Cohort (n=362, 156)
    41.20
    (11.29)
    40.47
    (11.11)
    BL (Day 0) for Day 533 Cohort (n=355, 156)
    41.28
    (11.20)
    40.53
    (11.25)
    BL (Day 0) for Day 617 Cohort (n=348, 153)
    41.23
    (11.28)
    40.67
    (11.26)
    BL (Day 0) for Day 729 Cohort (n=338, 146)
    41.21
    (11.28)
    40.24
    (11.11)
    BL (Day 0) for Day 813 Cohort (n=323, 145)
    41.23
    (11.34)
    40.19
    (11.20)
    BL (Day 0) for Day 897 Cohort (n=320, 139)
    41.36
    (11.41)
    40.28
    (11.33)
    BL (Day 0) for Day 981 Cohort (n=312, 136)
    41.40
    (11.39)
    40.32
    (11.45)
    BL (Day 0) for Day 1,093 Cohort (n=308, 137)
    41.40
    (11.25)
    40.33
    (11.41)
    BL (Day 0) for Day 1,177 Cohort (n=273, 124)
    41.28
    (11.47)
    40.19
    (11.06)
    BL (Day 0) for Day 1,261 Cohort (n=289, 133)
    41.29
    (11.45)
    40.26
    (11.50)
    BL (Day 0) for Day 1,345 Cohort (n=146, 60)
    42.11
    (11.81)
    39.99
    (10.83)
    BL (Day 0) for Day 1,457 Cohort (n=288, 128)
    41.35
    (11.45)
    40.06
    (11.35)
    BL (Day 0) for Day 1,625 Cohort (n=278, 125)
    41.25
    (11.60)
    40.16
    (11.44)
    BL (Day 0) for Day 1,821 Cohort (n=273, 124)
    41.39
    (11.60)
    40.03
    (11.23)
    BL (Day 0) for Day 1,989 Cohort (n=118, 54)
    41.73
    (11.58)
    39.61
    (9.98)
    BL (Day 0) for Day 2,185 Cohort (n=84, 38)
    42.00
    (11.97)
    37.55
    (9.95)
    69. Secondary Outcome
    Title Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n=370, 157)
    7.29
    (0.60)
    6.41
    (0.85)
    Day 449 (n=362, 156)
    6.84
    (0.63)
    7.73
    (0.97)
    Day 533 (n=355, 156)
    7.30
    (0.62)
    7.20
    (0.96)
    Day 617 (n=348, 153)
    7.15
    (0.64)
    6.88
    (0.94)
    Day 729 (n=338, 146)
    7.31
    (0.61)
    8.07
    (1.01)
    Day 813 (n=323, 145)
    6.98
    (0.67)
    7.15
    (1.01)
    Day 897 (n=320, 139)
    7.26
    (0.69)
    8.54
    (1.02)
    Day 981 (n=312, 136)
    6.82
    (0.69)
    7.76
    (1.02)
    Day 1,093 (n=308, 137)
    7.79
    (0.69)
    6.09
    (1.04)
    Day 1,177 (n=273, 124)
    6.93
    (0.73)
    7.65
    (1.09)
    Day 1,261 (n=289, 133)
    7.33
    (0.74)
    7.04
    (1.05)
    Day 1,345 (n=146, 60)
    6.37
    (1.00)
    7.42
    (1.43)
    Day 1,457 (n=288, 128)
    6.82
    (0.74)
    7.19
    (1.12)
    Day 1,625 (n=278, 125)
    6.60
    (0.74)
    6.99
    (1.15)
    Day 1,821 (n=273, 124)
    6.75
    (0.75)
    9.08
    (1.10)
    Day 1,989 (n=118, 54)
    5.53
    (1.14)
    8.74
    (1.60)
    Day 2,185 (n=84, 38)
    5.28
    (1.28)
    9.91
    (1.72)
    70. Secondary Outcome
    Title Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n=373, 160)
    28.79
    (9.12)
    28.09
    (8.88)
    BL (Day 0) for Day 449 Cohort (n=367, 157)
    28.62
    (9.06)
    28.07
    (8.95)
    BL (Day 0) for Day 533 Cohort (n=355, 157)
    28.63
    (9.13)
    28.05
    (8.91)
    BL (Day 0) for Day 617 Cohort (n=348, 155)
    28.71
    (9.13)
    28.02
    (8.91)
    BL (Day 0) for Day 729 Cohort(n=338, 148)
    28.68
    (9.20)
    28.01
    (8.93)
    BL (Day 0) for Day 813 Cohort (n=324, 147)
    28.41
    (8.97)
    28.01
    (9.01)
    BL (Day 0) for Day 897 Cohort (n=320, 140)
    28.36
    (8.99)
    27.93
    (9.11)
    BL (Day 0) for Day 981 Cohort (n=312, 137)
    28.43
    (9.01)
    28.10
    (9.15)
    BL (Day 0) for Day 1,093 Cohort (n=310, 138)
    28.43
    (8.98)
    28.10
    (9.11)
    BL (Day 0) for Day 1,177 Cohort (n=275, 125)
    28.70
    (8.95)
    27.91
    (8.85)
    BL (Day 0) for Day 1,261 Cohort (n=292, 135)
    28.62
    (9.12)
    28.17
    (9.13)
    BL (Day 0) for Day 1,345 Cohort (n=147, 61)
    28.70
    (8.97)
    26.49
    (8.34)
    BL (Day 0) for Day 1,457 Cohort (n=290, 129)
    28.35
    (9.11)
    28.24
    (9.03)
    BL (Day 0) for Day 1,625 Cohort (n=279, 126)
    28.68
    (9.10)
    27.98
    (8.87)
    BL (Day 0) for Day 1,821 Cohort (n=273, 125)
    28.50
    (9.07)
    28.50
    (9.03)
    BL (Day 0) for Day 1,989 Cohort (n=118, 55)
    27.78
    (8.86)
    27.75
    (9.35)
    BL (Day 0) for Day 2,185 Cohort (n=85, 38)
    26.94
    (7.79)
    26.25
    (7.45)
    71. Primary Outcome
    Title Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period
    Description Vital signs included body temperature, heart rate, and seated blood pressure. Clinically significant changes were defined as those that were not within the normal range for the participant.
    Time Frame Day 365 to Day 1,821. All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing.

    Outcome Measure Data

    Analysis Population Description
    All treated participants entering the OL period.
    Arm/Group Title ABA + MTX OL
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 529
    Body Temperature
    0
    0%
    Heart Rate
    0
    0%
    Blood Pressure
    0
    0%
    72. Primary Outcome
    Title Number of Participants Experiencing AEs of Special Interest in the OL Period
    Description AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest have been identified to be those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.
    Time Frame Day 365 to Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period.
    Arm/Group Title ABA + MTX OL
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 529
    Infections/Infestations
    452
    104.4%
    Neoplasms
    71
    16.4%
    Autoimmune Disorders
    52
    12%
    Acute Infusional AEs
    30
    6.9%
    Peri-Infusional AEs
    86
    19.9%
    73. Primary Outcome
    Title Mean BL Hematocrit in the OL Period
    Description Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
    Time Frame Baseline (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    Day 365 (n=365, 157)
    38.79
    (4.60)
    39.38
    (4.32)
    Day 729 (n=328, 143)
    38.72
    (4.52)
    39.39
    (4.19)
    Day 1,093 (n=312, 138)
    38.69
    (4.57)
    39.46
    (4.33)
    Day 1,457 (n=292, 130)
    38.59
    (4.48)
    39.40
    (4.27)
    Day 1,821 (n=262,124)
    38.70
    (4.44)
    39.48
    (4.43)
    Day 1,905 (n=134, 68)
    38.11
    (4.56)
    39.83
    (3.90)
    Day 1,989 (n=121,56)
    38.07
    (4.78)
    39.99
    (4.12)
    Day 2,073 (n=81,38)
    37.11
    (3.92)
    39.12
    (3.45)
    Day 2,185 (n=82,37)
    37.25
    (3.83)
    39.02
    (3.45)
    74. Primary Outcome
    Title Mean Change From BL in Participant Hematocrit in the OL Period
    Description All changes in participant laboratory parameters were monitored on each day of study drug administration.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    Day 365 (n=365, 157)
    1.87
    (0.21)
    -0.04
    (0.24)
    Day 729 (n=328, 143)
    2.16
    (0.20)
    1.36
    (0.31)
    Day 1,093 (n=312, 138)
    1.41
    (0.20)
    0.56
    (0.35)
    Day 1,457 (n=292, 130)
    1.60
    (0.23)
    1.01
    (0.38)
    Day 1,821 (n=262,124)
    0.85
    (0.25)
    0.78
    (0.34)
    Day 1,905 (n=134, 68)
    1.63
    (0.34)
    0.59
    (0.48)
    Day 1,989 (n=121,56)
    1.42
    (0.38)
    0.94
    (0.49)
    Day 2,073 (n=81,38)
    1.79
    (0.42)
    0.20
    (0.62)
    Day 2,185 (n=82,37)
    1.42
    (0.37)
    0.65
    (0.61)
    75. Primary Outcome
    Title Mean BL Platelet Count in the OL Period
    Description Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    Day 365 (n=365, 157)
    352.7
    (108.5)
    339.2
    (97.92)
    Day 729 (n=328, 143)
    351.8
    (110.4)
    334.2
    (91.41)
    Day 1,093 (n=312, 138)
    351.7
    (107.9)
    334.8
    (96.35)
    Day 1,457 (n=292, 130)
    352.7
    (106.4)
    335.0
    (98.59)
    Day 1,821 (n=262,124)
    351.1
    (98.28)
    334.2
    (97.52)
    Day 1,905 (n=134, 68)
    365.7
    (113.9)
    333.7
    (89.66)
    Day 1,989 (n=121,56)
    366.1
    (115.3)
    326.6
    (86.82)
    Day 2,073 (n=81,38)
    375.2
    (118.6)
    321.2
    (90.51)
    Day 2,185 (n=82,37)
    380.4
    (119.7)
    320.3
    (91.59)
    76. Primary Outcome
    Title Mean Change From BL in Participant Platelet Count in the OL Period
    Description All changes in participant laboratory parameters were monitored on each day of study drug administration.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    Day 365 (n=365, 157)
    -66.9
    (4.29)
    -29.9
    (5.58)
    Day 729 (n=328, 143)
    -59.5
    (4.64)
    -45.4
    (6.64)
    Day 1,093 (n=312, 138)
    -53.5
    (5.10)
    -36.8
    (7.21)
    Day 1,457 (n=292, 130)
    -59.0
    (5.64)
    -48.7
    (7.40)
    Day 1,821 (n=262,124)
    -68.9
    (4.92)
    -59.2
    (7.38)
    Day 1,905 (n=134, 68)
    -55.1
    (14.57)
    -47.5
    (10.71)
    Day 1,989 (n=121,56)
    -63.7
    (8.33)
    -50.3
    (9.83)
    Day 2,073 (n=81,38)
    -69.6
    (10.64)
    -55.3
    (11.68)
    Day 2,185 (n=82,37)
    -80.5
    (10.68)
    -53.9
    (10.34)
    77. Primary Outcome
    Title Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
    Description Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    Hemoglobin Day 365 (n=365, 157)
    12.49
    (1.57)
    12.70
    (1.56)
    Total Protein Day 365 (n=365, 157)
    7.23
    (0.52)
    7.35
    (0.56)
    Albumin Day 365 (n=365, 157)
    4.03
    (0.33)
    4.13
    (0.30)
    Hemoglobin Day 729 (n=328, 143)
    12.50
    (1.54)
    12.72
    (1.49)
    Total Protein Day 729 (n=328, 143)
    7.22
    (0.52)
    7.34
    (0.55)
    Albumin Day 729 (n=328, 143)
    4.01
    (0.33)
    4.12
    (0.29)
    Hemoglobin Day 1,093 (n=312, 138)
    12.48
    (1.55)
    12.75
    (1.55)
    Total Protein Day 1,093 (n=312, 138)
    7.23
    (0.51)
    7.34
    (0.55)
    Albumin Day 1,093 (n=312, 138)
    4.02
    (0.33)
    4.11
    (0.30)
    Hemoglobin Day 1,457 (n=292, 130)
    12.46
    (1.54)
    12.74
    (1.50)
    Total Protein Day 1,457 (n=292, 130)
    7.23
    (0.51)
    7.35
    (0.57)
    Albumin Day 1,457 (n=292, 130)
    4.02
    (0.33)
    4.12
    (0.30)
    Hemoglobin Day 1,821 (n=262,124)
    12.49
    (1.51)
    12.79
    (1.57)
    Total Protein Day 1,821 (n=262,124)
    7.23
    (0.49)
    7.37
    (0.56)
    Albumin Day 1,821 (n=262,124)
    4.02
    (0.33)
    4.13
    (0.30)
    Hemoglobin Day 1,905 (n=134, 68)
    12.35
    (1.55)
    12.88
    (1.33)
    Total Protein Day 1,905 (n=134, 68)
    7.27
    (0.52)
    7.35
    (0.53)
    Albumin Day 1,905 (n=134, 68)
    4.03
    (0.32)
    4.13
    (0.30)
    Hemoglobin Day 1,989 (n=121,56)
    12.35
    (1.60)
    12.98
    (1.46)
    Total Protein Day 1,989 (n=121,56)
    7.25
    (0.51)
    7.38
    (0.55)
    Albumin Day 1,989 (n=121,56)
    4.03
    (0.33)
    4.12
    (0.30)
    Hemoglobin Day 2,073 (n=81,38)
    12.21
    (1.46)
    12.84
    (1.18)
    Total Protein Day 2,073 (n=81,38)
    7.18
    (0.47)
    7.27
    (0.44)
    Albumin Day 2,073 (n=81,38)
    3.98
    (0.33)
    4.08
    (0.33)
    Hemoglobin Day 2,185 (n=82,37)
    12.25
    (1.44)
    12.82
    (1.19)
    Total Protein Day 2,185 (n=82,37)
    7.18
    (0.47)
    7.28
    (0.45)
    Albumin Day 2,185 (n=82,37)
    3.97
    (0.32)
    4.08
    (0.33)
    78. Primary Outcome
    Title Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
    Description All changes in participant laboratory parameters were monitored on each day of study drug administration.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    Hemoglobin Day 365 (n=365, 157)
    0.62
    (0.07)
    -0.09
    (0.08)
    Total Protein Day 365 (n=365, 157)
    -0.26
    (0.02)
    -0.25
    (0.04)
    Albumin Day 365 (n=365, 157)
    0.22
    (0.02)
    0.02
    (0.02)
    Hemoglobin Day 729 (n=328, 143)
    0.95
    (0.07)
    0.61
    (0.10)
    Total Protein Day 729 (n=328, 143)
    -0.01
    (0.03)
    -0.05
    (0.05)
    Albumin Day 729 (n=328, 143)
    0.31
    (0.02)
    0.23
    (0.03)
    Hemoglobin Day 1,093 (n=312, 138)
    0.75
    (0.07)
    0.40
    (0.11)
    Total Protein Day 1,093 (n=312, 138)
    -0.16
    (0.03)
    -0.26
    (0.04)
    Albumin Day 1,093 (n=312, 138)
    0.13
    (0.02)
    0.02
    (0.03)
    Hemoglobin Day 1,457 (n=292, 130)
    0.80
    (0.07)
    0.52
    (0.12)
    Total Protein Day 1,457 (n=292, 130)
    -0.28
    (0.03)
    -0.35
    (0.05)
    Albumin Day 1,457 (n=292, 130)
    0.07
    (0.02)
    -0.02
    (0.03)
    Hemoglobin Day 1,821 (n=262,124)
    0.79
    (0.08)
    0.70
    (0.11)
    Total Protein Day 1,821 (n=262,124)
    -0.27
    (0.03)
    -0.35
    (0.05)
    Albumin Day 1,821 (n=262,124)
    0.06
    (0.02)
    -0.05
    (0.03)
    Hemoglobin Day 1,905 (n=134, 68)
    0.74
    (0.12)
    0.39
    (0.16)
    Total Protein Day 1,905 (n=134, 68)
    -0.32
    (0.05)
    -0.31
    (0.07)
    Albumin Day 1,905 (n=134, 68)
    0.05
    (0.03)
    -0.06
    (0.04)
    Hemoglobin Day 1,989 (n=121,56)
    0.59
    (0.13)
    0.41
    (0.17)
    Total Protein Day 1,989 (n=121,56)
    -0.29
    (0.05)
    -0.33
    (0.07)
    Albumin Day 1,989 (n=121,56)
    0.08
    (0.03)
    0.01
    (0.05)
    Hemoglobin Day 2,073 (n=81,38)
    0.78
    (0.15)
    0.23
    (0.22)
    Total Protein Day 2,073 (n=81,38)
    -0.21
    (0.04)
    -0.24
    (0.09)
    Albumin Day 2,073 (n=81,38)
    0.22
    (0.03)
    0.09
    (0.06)
    Hemoglobin Day 2,185 (n=82,37)
    0.69
    (0.14)
    0.40
    (0.21)
    Total Protein Day 2,185 (n=82,37)
    -0.20
    (0.04)
    -0.12
    (0.09)
    Albumin Day 2,185 (n=82,37)
    0.30
    (0.03)
    0.25
    (0.06)
    79. Secondary Outcome
    Title Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n=373, 160)
    8.61
    (0.58)
    6.44
    (0.84)
    Day 449 (n=367, 157)
    9.44
    (0.57)
    9.13
    (0.93)
    Day 533 (n=355, 157)
    9.43
    (0.59)
    9.46
    (0.97)
    Day 617 (n=348, 155)
    9.43
    (0.57)
    9.80
    (0.98)
    Day 729 (n=338, 148)
    9.51
    (0.61)
    9.63
    (1.03)
    Day 813 (n=324, 147)
    10.17
    (0.62)
    9.71
    (1.06)
    Day 897 (n=320, 140)
    9.95
    (0.60)
    9.39
    (1.07)
    Day 981 (n=312, 137)
    10.23
    (0.63)
    10.45
    (1.10)
    Day 1,093 (n=310, 138)
    9.40
    (0.63)
    10.35
    (1.15)
    Day 1,177 (n=275, 125)
    9.74
    (0.71)
    10.57
    (1.17)
    Day 1,261 (n=292, 135)
    9.95
    (0.68)
    9.92
    (1.14)
    Day 1,345 (n=147, 61)
    9.18
    (1.00)
    10.75
    (1.84)
    Day 1,457 (n=290, 129)
    10.55
    (0.70)
    10.03
    (1.15)
    Day 1,625 (n=279, 126)
    9.80
    (0.72)
    9.68
    (1.13)
    Day 1,821 (n=273, 125)
    9.48
    (0.75)
    9.08
    (1.10)
    Day 1,989 (n=118, 55)
    11.35
    (1.17)
    9.22
    (1.92)
    Day 2,185 (n=85, 38)
    10.06
    (1.22)
    10.90
    (2.25)
    80. Secondary Outcome
    Title Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n=372, 160)
    32.06
    (7.78)
    32.08
    (7.34)
    BL (Day 0) for Day 449 Cohort (n=367, 157)
    31.88
    (7.64)
    32.02
    (7.40)
    BL (Day 0) for Day 533 Cohort (n=355, 157)
    32.02
    (7.78)
    32.11
    (7.39)
    BL (Day 0) for Day 617 Cohort (n=348, 156)
    32.04
    (7.81)
    32.14
    (7.41)
    BL (Day 0) for Day 729 Cohort (n=338, 148)
    32.12
    (7.86)
    31.79
    (6.83)
    BL (Day 0) for Day 813 Cohort (n=324, 147)
    31.93
    (7.65)
    31.91
    (7.14)
    BL (Day 0) for Day 897 Cohort (n=320, 140)
    31.91
    (7.56)
    32.01
    (7.27)
    BL (Day 0) for Day 981 Cohort (n=312, 137)
    31.83
    (7.52)
    32.05
    (7.32)
    BL (Day 0) for Day 1,093 Cohort (n=309, 138)
    31.82
    (7.52)
    32.02
    (7.31)
    BL (Day 0) for Day 1,177 Cohort (n=275, 125)
    31.84
    (7.55)
    31.88
    (7.22)
    BL (Day 0) for Day 1,261 Cohort (n=292, 134)
    31.83
    (7.56)
    32.09
    (7.38)
    BL (Day 0) for Day 1,345 Cohort (n=147, 61)
    31.90
    (7.13)
    31.66
    (6.53)
    BL (Day 0) for Day 1,457 Cohort (n=289, 129)
    31.82
    (7.57)
    32.08
    (7.34)
    BL (Day 0) for Day 1,625 Cohort (n=279, 126)
    31.88
    (7.60)
    31.96
    (7.25)
    BL (Day 0) for Day 1,821 Cohort (n=273, 125)
    31.87
    (7.71)
    31.71
    (6.95)
    BL (Day 0) for Day 1,989 Cohort (n=118, 55)
    31.79
    (7.72)
    31.43
    (6.92)
    BL (Day 0) for Day 2,185 Cohort (n=84, 38)
    30.98
    (6.88)
    30.56
    (5.05)
    81. Secondary Outcome
    Title Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n=372, 160)
    10.10
    (0.67)
    7.59
    (0.96)
    Day 449 (n=367, 157)
    10.66
    (0.70)
    10.89
    (1.04)
    Day 533 (n=355, 157)
    11.18
    (0.70)
    10.98
    (1.02)
    Day 617 (n=348, 156)
    10.93
    (0.73)
    11.61
    (1.05)
    Day 729 (n=338, 148)
    11.33
    (0.72)
    11.50
    (1.04)
    Day 813 (n=324, 147)
    10.56
    (0.73)
    10.57
    (1.00)
    Day 897 (n=320, 140)
    10.13
    (0.74)
    10.96
    (1.06)
    Day 981 (n=312, 137)
    10.96
    (0.76)
    10.88
    (1.07)
    Day 1,093 (n=309, 138)
    11.82
    (0.76)
    9.72
    (1.04)
    Day 1,177 (n=275, 125)
    11.32
    (0.82)
    11.09
    (1.18)
    Day 1,261 (n=292, 134)
    10.25
    (0.82)
    11.61
    (1.08)
    Day 1,345 (n=147, 61)
    9.09
    (1.13)
    10.32
    (1.67)
    Day 1,457 (n=289, 129)
    10.57
    (0.79)
    11.39
    (1.13)
    Day 1,625 (n=279, 126)
    10.11
    (0.80)
    11.10
    (1.10)
    Day 1,821 (n=273, 125)
    11.25
    (0.84)
    10.62
    (1.15)
    Day 1,989 (n=118, 55)
    10.79
    (1.31)
    10.42
    (1.71)
    Day 2,185 (n=84, 38)
    9.04
    (1.41)
    12.84
    (1.96)
    82. Secondary Outcome
    Title Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    AlAll treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n=373, 160)
    33.13
    (7.37)
    33.43
    (7.53)
    BL (Day 0) for Day 449 Cohort (n=367, 157)
    32.95
    (7.36)
    33.47
    (7.56)
    BL (Day 0) for Day 533 Cohort (n=355, 157)
    33.05
    (7.36)
    33.27
    (7.49)
    BL (Day 0) for Day 617 Cohort (n=348, 156)
    33.00
    (7.30)
    33.49
    (7.59)
    BL (Day 0) for Day 729 Cohort (n=338, 148)
    32.94
    (7.38)
    33.44
    (7.57)
    BL (Day 0) for Day 813 Cohort (n=324, 147)
    32.80
    (7.27)
    33.53
    (7.65)
    BL (Day 0) for Day 897 Cohort (n=320, 140)
    32.80
    (7.33)
    33.29
    (7.67)
    BL (Day 0) for Day 981 Cohort (n=312, 137)
    32.79
    (7.28)
    33.29
    (7.74)
    BL (Day 0) for Day 1,093 Cohort (n=309, 138)
    32.88
    (7.30)
    33.29
    (7.71)
    BL (Day 0) for Day 1,177 Cohort (n=275, 125)
    32.84
    (7.34)
    33.13
    (7.71)
    BL (Day 0) for Day 1,261 Cohort (n=291, 134)
    32.81
    (7.50)
    33.31
    (7.77)
    BL (Day 0) for Day 1,345 Cohort (n=147, 61)
    32.57
    (7.37)
    31.83
    (6.61)
    BL (Day 0) for Day 1,457 Cohort (n=289, 129)
    32.73
    (7.35)
    33.48
    (7.74)
    BL (Day 0) for Day 1,625 Cohort (n=279, 126)
    32.78
    (7.36)
    33.20
    (7.52)
    BL (Day 0) for Day 1,821 Cohort (n=273, 125)
    32.85
    (7.44)
    33.56
    (7.71)
    BL (Day 0) for Day 1,989 Cohort (n=118, 55)
    31.98
    (7.20)
    32.81
    (7.66)
    BL (Day 0) for Day 2,185 Cohort (n=85, 38)
    31.49
    (6.81)
    31.40
    (5.91)
    83. Secondary Outcome
    Title Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n=373, 160)
    12.08
    (0.51)
    7.98
    (0.76)
    Day 449 (n=367, 157)
    12.38
    (0.53)
    11.78
    (0.82)
    Day 533 (n=355, 157)
    11.94
    (0.55)
    12.53
    (0.86)
    Day 617 (n=348, 156)
    12.52
    (0.56)
    11.97
    (0.90)
    Day 729 (n=338, 148)
    12.84
    (0.57)
    12.06
    (0.88)
    Day 813 (n=324, 147)
    13.13
    (0.60)
    12.25
    (0.85)
    Day 897 (n=320, 140)
    12.44
    (0.59)
    11.84
    (0.85)
    Day 981 (n=312, 137)
    12.86
    (0.63)
    12.87
    (0.87)
    Day 1,093 (n=309, 138)
    13.34
    (0.60)
    12.93
    (0.91)
    Day 1,177 (n=275, 125)
    13.21
    (0.67)
    13.44
    (1.02)
    Day 1,261 (n=291, 134)
    12.83
    (0.68)
    13.31
    (0.94)
    Day 1,345 (n=147, 61)
    12.44
    (0.98)
    13.40
    (1.42)
    Day 1,457 (n=289, 129)
    13.13
    (0.60)
    11.74
    (0.97)
    Day 1,625 (n=279, 126)
    12.89
    (0.63)
    13.36
    (0.89)
    Day 1,821 (n=273, 125)
    12.56
    (0.67)
    12.65
    (0.95)
    Day 1,989 (n=118, 55)
    13.45
    (0.98)
    13.19
    (1.41)
    Day 2,185 (n=85, 38)
    10.44
    (1.18)
    14.28
    (1.47)
    84. Secondary Outcome
    Title Mean BL General Health Component of the SF-36 by Visit in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n=373, 160)
    35.43
    (8.41)
    35.27
    (7.73)
    BL (Day 0) for Day 449 Cohort (n=367, 157)
    35.33
    (8.45)
    35.28
    (7.80)
    BL (Day 0) for Day 533 Cohort (n=355, 157)
    35.34
    (8.40)
    35.17
    (7.73)
    BL (Day 0) for Day 617 Cohort (n=348, 156)
    35.41
    (8.38)
    35.21
    (7.72)
    BL (Day 0) for Day 729 Cohort (n=338, 148)
    35.47
    (8.46)
    35.16
    (7.61)
    BL (Day 0) for Day 813 Cohort (n=324, 147)
    35.59
    (8.45)
    35.19
    (7.62)
    BL (Day 0) for Day 897 Cohort (n=320, 140)
    35.72
    (8.50)
    35.22
    (7.78)
    BL (Day 0) for Day 981 Cohort (n=312, 137)
    35.67
    (8.46)
    35.38
    (7.79)
    BL (Day 0) for Day 1,093 Cohort (n=312, 138)
    35.69
    (8.52)
    35.32
    (7.80)
    BL (Day 0) for Day 1,177 Cohort (n=275, 125)
    35.50
    (8.38)
    35.54
    (7.87)
    BL (Day 0) for Day 1,261 Cohort (n=291, 135)
    35.65
    (8.38)
    35.31
    (7.88)
    BL (Day 0) for Day 1,345 Cohort (n=147, 61)
    35.88
    (8.68)
    33.78
    (7.96)
    BL (Day 0) for Day 1,457 Cohort (n=290, 129)
    35.56
    (8.48)
    35.43
    (7.85)
    BL (Day 0) for Day 1,625 Cohort (n=280, 126)
    35.67
    (8.33)
    35.23
    (7.91)
    BL (Day 0) for Day 1,821 Cohort (n=273, 125)
    35.61
    (8.46)
    35.56
    (7.83)
    BL (Day 0) for Day 1,989 Cohort (n=119, 55)
    34.87
    (8.65)
    34.94
    (8.67)
    BL (Day 0) for Day 2,185 Cohort (n=85, 38)
    34.29
    (9.03)
    33.71
    (8.26)
    85. Secondary Outcome
    Title Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n=373, 160)
    6.88
    (0.46)
    5.43
    (0.58)
    Day 449 (n=367, 157)
    6.94
    (0.46)
    7.32
    (0.71)
    Day 533 (n=355, 157)
    6.82
    (0.47)
    7.88
    (0.68)
    Day 617 (n=348, 156)
    7.22
    (0.45)
    7.87
    (0.70)
    Day 729 (n=338, 148)
    7.31
    (0.46)
    7.90
    (0.68)
    Day 813 (n=324, 147)
    6.89
    (0.49)
    7.63
    (0.69)
    Day 897 (n=320, 140)
    6.86
    (0.52)
    8.24
    (0.79)
    Day 981 (n=312, 137)
    7.31
    (0.53)
    8.45
    (0.79)
    Day 1,093 (n=312, 138)
    7.24
    (0.55)
    8.36
    (0.82)
    Day 1,177 (n=275, 125)
    7.48
    (0.57)
    8.55
    (0.94)
    Day 1,261 (n=291, 135)
    7.18
    (0.58)
    8.17
    (0.83)
    Day 1,345 (n=147, 61)
    6.19
    (0.73)
    8.45
    (1.36)
    Day 1,457 (n=290, 129)
    7.07
    (0.57)
    8.32
    (0.86)
    Day 1,625 (n=280, 126)
    7.27
    (0.57)
    8.10
    (0.81)
    Day 1,821 (n=273, 125)
    7.50
    (0.60)
    7.53
    (0.81)
    Day 1,989 (n=119, 55)
    6.55
    (0.81)
    7.05
    (1.14)
    Day 2,185 (n=85, 38)
    5.93
    (1.02)
    8.76
    (1.38)
    86. Secondary Outcome
    Title Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n=373, 160)
    35.58
    (10.10)
    34.98
    (9.72)
    BL (Day 0) for Day 449 Cohort (n=368, 157)
    35.42
    (10.13)
    34.91
    (9.75)
    BL (Day 0) for Day 533 Cohort (n=355, 157)
    35.52
    (10.18)
    34.94
    (9.80)
    BL (Day 0) for Day 617 Cohort (n=348, 156)
    35.46
    (10.14)
    35.01
    (9.80)
    BL (Day 0) for Day 729 Cohort (n=338, 148)
    35.70
    (10.24)
    34.51
    (9.61)
    BL (Day 0) for Day 813 Cohort (n=324, 147)
    35.47
    (10.17)
    34.57
    (9.73)
    BL (Day 0) for Day 897 Cohort (n=320, 140)
    35.47
    (10.20)
    34.65
    (9.82)
    BL (Day 0) for Day 981 Cohort (n=312, 137)
    35.46
    (10.17)
    34.67
    (9.90)
    BL (Day 0) for Day 1,093 Cohort (n=312, 138)
    35.60
    (10.07)
    34.68
    (9.86)
    BL (Day 0) for Day 1,177 Cohort (n=275, 125)
    35.52
    (10.10)
    34.51
    (9.60)
    BL (Day 0) for Day 1,261 Cohort (n=292, 134)
    35.48
    (10.24)
    34.82
    (9.93)
    BL (Day 0) for Day 1,345 Cohort (n=147, 62)
    35.65
    (10.53)
    33.24
    (9.09)
    BL (Day 0) for Day 1,457 Cohort (n=289, 129)
    35.56
    (10.28)
    34.83
    (9.82)
    BL (Day 0) for Day 1,625 Cohort (n=280, 126)
    35.44
    (10.45)
    34.73
    (9.90)
    BL (Day 0) for Day 1,821 Cohort (n=273, 125)
    35.56
    (10.42)
    34.86
    (9.52)
    BL (Day 0) for Day 1,989 Cohort (n=118, 55)
    34.50
    (10.41)
    33.75
    (8.92)
    BL (Day 0) for Day 2,185 Cohort (n=85, 38)
    34.66
    (10.43)
    31.85
    (8.21)
    87. Secondary Outcome
    Title Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n=373, 160)
    9.01
    (0.61)
    7.12
    (0.77)
    Day 449 (n=368, 157)
    9.74
    (0.61)
    9.47
    (0.91)
    Day 533 (n=355, 157)
    9.88
    (0.62)
    9.44
    (0.92)
    Day 617 (n=348, 156)
    9.48
    (0.62)
    8.66
    (0.92)
    Day 729 (n=338, 148)
    9.99
    (0.63)
    9.90
    (0.94)
    Day 813 (n=324, 147)
    9.80
    (0.67)
    8.97
    (0.92)
    Day 897 (n=320, 140)
    9.96
    (0.67)
    9.81
    (0.99)
    Day 981 (n=312, 137)
    9.71
    (0.66)
    9.51
    (1.00)
    Day 1,093 (n=312, 138)
    10.16
    (0.68)
    8.61
    (0.98)
    Day 1,177 (n=275, 125)
    9.28
    (0.71)
    9.64
    (1.06)
    Day 1,261 (n=292, 134)
    9.54
    (0.73)
    9.92
    (0.99)
    Day 1,345 (n=147, 62)
    9.01
    (1.11)
    8.84
    (1.42)
    Day 1,457 (n=289, 129)
    10.16
    (0.72)
    9.26
    (1.01)
    Day 1,625 (n=280, 126)
    9.67
    (0.73)
    9.05
    (0.99)
    Day 1,821 (n=273, 125)
    8.93
    (0.75)
    8.16
    (0.91)
    Day 1,989 (n=118, 55)
    9.34
    (1.17)
    10.17
    (1.37)
    Day 2,185 (n=85, 38)
    7.98
    (1.31)
    10.57
    (1.40)
    88. Secondary Outcome
    Title Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n= 370, 158)
    35.78
    (13.63)
    33.40
    (12.53)
    BL (Day 0) for Day 449 Cohort (n=365, 157)
    35.71
    (13.61)
    33.26
    (12.44)
    BL (Day 0) for Day 533 Cohort (n=355, 156)
    35.61
    (13.57)
    33.39
    (12.61)
    BL (Day 0) for Day 617 Cohort (n=348, 155)
    35.66
    (13.55)
    33.52
    (12.60)
    BL (Day 0) for Day 729 Cohort (n=338, 147)
    35.49
    (13.49)
    33.34
    (12.45)
    BL (Day 0) for Day 813 Cohort (n=324, 146)
    35.38
    (13.42)
    33.26
    (12.52)
    BL (Day 0) for Day 897 Cohort (n=320, 139)
    35.46
    (13.40)
    33.13
    (12.60)
    BL (Day 0) for Day 981 Cohort (n=312, 136)
    35.42
    (13.36)
    33.19
    (12.65)
    BL (Day 0) for Day 1,093 Cohort (n=309, 137)
    35.40
    (13.36)
    33.27
    (12.64)
    BL (Day 0) for Day 1,177 Cohort (n=275, 124)
    35.46
    (13.34)
    33.42
    (12.57)
    BL (Day 0) for Day 1,261 Cohort (n=291, 133)
    35.61
    (13.44)
    33.00
    (12.51)
    BL (Day 0) for Day 1,345 Cohort (n=146, 60)
    36.00
    (13.78)
    32.69
    (12.39)
    BL (Day 0) for Day 1,457 Cohort (n=289, 128)
    35.36
    (13.44)
    32.79
    (12.31)
    BL (Day 0) for Day 1,625 Cohort (n=279, 125)
    35.33
    (13.39)
    32.92
    (12.48)
    BL (Day 0) for Day 1,821 Cohort (n=273, 124)
    35.43
    (13.50)
    32.74
    (12.14)
    BL (Day 0) for Day 1,989 Cohort (n=118, 54)
    35.61
    (13.67)
    30.76
    (11.58)
    BL (Day 0) for Day 2,185 Cohort (n=85, 38)
    35.26
    (13.76)
    29.28
    (10.32)
    89. Secondary Outcome
    Title Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n= 370, 158)
    8.97
    (0.81)
    8.60
    (1.25)
    Day 449 (n=365, 157)
    8.02
    (0.86)
    10.80
    (1.28)
    Day 533 (n=355, 156)
    8.44
    (0.88)
    10.13
    (1.30)
    Day 617 (n=348, 155)
    8.60
    (0.88)
    10.47
    (1.34)
    Day 729 (n=338, 147)
    8.96
    (0.86)
    10.89
    (1.34)
    Day 813 (n=324, 146)
    8.71
    (0.89)
    11.04
    (1.37)
    Day 897 (n=320, 139)
    8.48
    (0.90)
    11.67
    (1.41)
    Day 981 (n=312, 136)
    8.61
    (0.92)
    11.70
    (1.42)
    Day 1,093 (n=309, 137)
    9.31
    (0.94)
    9.46
    (1.41)
    Day 1,177 (n=275, 124)
    8.35
    (1.01)
    11.17
    (1.48)
    Day 1,261 (n=291, 133)
    8.43
    (1.00)
    10.53
    (1.42)
    Day 1,345 (n=146, 60)
    7.22
    (1.35)
    11.41
    (2.23)
    Day 1,457 (n=289, 128)
    7.51
    (0.98)
    10.70
    (1.46)
    Day 1,625 (n=279, 125)
    7.91
    (1.02)
    9.44
    (1.53)
    Day 1,821 (n=273, 124)
    7.39
    (0.71)
    6.56
    (1.09)
    Day 1,989 (n=118, 54)
    7.81
    (1.60)
    12.49
    (2.18)
    Day 2,185 (n=85, 38)
    7.06
    (1.69)
    16.08
    (2.17)
    90. Secondary Outcome
    Title Mean BL Vitality Component of the SF-36 by Visit in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n=373, 159)
    40.93
    (9.14)
    41.29
    (8.35)
    BL (Day 0) for Day 449 Cohort (n=368, 156)
    40.77
    (9.11)
    41.21
    (8.38)
    BL (Day 0) for Day 533 Cohort (n=355, 156)
    40.68
    (8.99)
    41.21
    (8.40)
    BL (Day 0) for Day 617 Cohort (n=348, 155)
    40.77
    (9.02)
    41.40
    (8.37)
    BL (Day 0) for Day 729 Cohort (n=338, 147)
    40.74
    (9.11)
    41.19
    (8.34)
    BL (Day 0) for Day 813 Cohort (n=323, 146)
    40.60
    (9.06)
    41.27
    (8.46)
    BL (Day 0) for Day 897 Cohort (n=320, 140)
    40.79
    (9.11)
    41.34
    (8.45)
    BL (Day 0) for Day 981 Cohort (n=312, 137)
    40.85
    (9.00)
    41.43
    (8.45)
    BL (Day 0) for Day 1,093 Cohort (n=312, 138)
    40.85
    (9.07)
    41.33
    (8.50)
    BL (Day 0) for Day 1,177 Cohort (n=273, 125)
    40.69
    (9.23)
    41.23
    (8.42)
    BL (Day 0) for Day 1,261 Cohort (n=292, 134)
    40.78
    (9.15)
    41.31
    (8.57)
    BL (Day 0) for Day 1,345 Cohort (n=147, 62)
    41.30
    (9.39)
    40.64
    (7.84)
    BL (Day 0) for Day 1,457 Cohort (n=290, 129)
    40.79
    (9.21)
    41.47
    (8.17)
    BL (Day 0) for Day 1,625 Cohort (n=280, 126)
    40.84
    (9.18)
    41.23
    (8.29)
    BL (Day 0) for Day 1,821 Cohort (n=273, 125)
    40.82
    (9.27)
    41.47
    (8.36)
    BL (Day 0) for Day 1,989 Cohort (n=118, 55)
    42.19
    (8.85)
    41.72
    (8.01)
    BL (Day 0) for Day 2,185 Cohort (n=85, 38)
    41.16
    (9.08)
    39.88
    (8.31)
    91. Secondary Outcome
    Title Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n=373, 159)
    8.58
    (0.55)
    6.04
    (0.68)
    Day 449 (n=368, 156)
    8.29
    (0.55)
    8.70
    (0.76)
    Day 533 (n=355, 156)
    8.68
    (0.52)
    8.09
    (0.81)
    Day 617 (n=348, 155)
    8.61
    (0.53)
    8.46
    (0.79)
    Day 729 (n=338, 147)
    8.69
    (0.55)
    8.41
    (0.80)
    Day 813 (n=323, 146)
    8.99
    (0.58)
    8.22
    (0.83)
    Day 897 (n=320, 140)
    8.69
    (0.57)
    8.53
    (0.81)
    Day 981 (n=312, 137)
    8.85
    (0.58)
    7.52
    (0.83)
    Day 1,093 (n=312, 138)
    8.98
    (0.56)
    7.53
    (0.82)
    Day 1,177 (n=273, 125)
    9.08
    (0.63)
    8.08
    (0.85)
    Day 1,261 (n=292, 134)
    8.39
    (0.64)
    8.14
    (0.84)
    Day 1,345 (n=147, 62)
    8.29
    (0.91)
    6.39
    (1.25)
    Day 1,457 (n=290, 129)
    9.19
    (0.62)
    7.57
    (0.87)
    Day 1,625 (n=280, 126)
    8.77
    (0.64)
    8.20
    (0.85)
    Day 1,821 (n=273, 125)
    8.96
    (0.66)
    7.42
    (0.84)
    Day 1,989 (n=118, 55)
    7.60
    (0.99)
    7.99
    (1.26)
    Day 2,185 (n=85, 38)
    7.06
    (1.11)
    9.61
    (1.28)
    92. Secondary Outcome
    Title Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n=373, 159)
    39.08
    (11.55)
    39.43
    (11.09)
    BL (Day 0) for Day 449 Cohort (n=368, 156)
    38.87
    (11.46)
    39.33
    (11.14)
    BL (Day 0) for Day 533 Cohort (n=355, 156)
    38.89
    (11.44)
    39.40
    (11.18)
    BL (Day 0) for Day 617 Cohort (n=348, 155)
    38.76
    (11.46)
    39.49
    (11.14)
    BL (Day 0) for Day 729 Cohort (n=338, 147)
    38.75
    (11.56)
    39.05
    (11.18)
    BL (Day 0) for Day 813 Cohort (n=323, 146)
    38.85
    (11.57)
    39.01
    (11.19)
    BL (Day 0) for Day 897 Cohort (n=320, 140)
    38.96
    (11.66)
    39.03
    (11.35)
    BL (Day 0) for Day 981 Cohort (n=312, 137)
    39.06
    (11.58)
    39.09
    (11.46)
    BL (Day 0) for Day 1,093 Cohort (n=312, 138)
    39.16
    (11.47)
    39.08
    (11.42)
    BL (Day 0) for Day 1,177 Cohort (n=273, 125)
    38.88
    (11.54)
    38.67
    (11.22)
    BL (Day 0) for Day 1,261 Cohort (n=292, 134)
    38.81
    (11.56)
    39.15
    (11.49)
    BL (Day 0) for Day 1,345 Cohort (n=147, 62)
    39.91
    (11.46)
    39.33
    (11.21)
    BL (Day 0) for Day 1,457 Cohort (n=290, 129)
    38.83
    (11.62)
    38.93
    (11.42)
    BL (Day 0) for Day 1,625 Cohort (n=280, 126)
    38.88
    (11.66)
    38.97
    (11.46)
    BL (Day 0) for Day 1,821 Cohort (n=273, 125)
    39.06
    (11.72)
    38.95
    (11.44)
    BL (Day 0) for Day 1,989 Cohort (n=118, 55)
    38.95
    (10.99)
    39.90
    (10.63)
    BL (Day 0) for Day 2,185 Cohort (n=85, 38)
    39.32
    (12.04)
    37.40
    (10.09)
    93. Secondary Outcome
    Title Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
    Description The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n=373, 159)
    7.02
    (0.59)
    5.31
    (0.78)
    Day 449 (n=368, 156)
    7.27
    (0.58)
    6.45
    (0.89)
    Day 533 (n=355, 156)
    7.72
    (0.61)
    6.49
    (0.88)
    Day 617 (n=348, 155)
    7.60
    (0.61)
    6.03
    (0.93)
    Day 729 (n=338, 147)
    7.49
    (0.61)
    7.38
    (0.96)
    Day 813 (n=323, 146)
    7.26
    (0.66)
    5.72
    (0.93)
    Day 897 (n=320, 140)
    7.65
    (0.67)
    7.29
    (0.96)
    Day 981 (n=312, 137)
    7.13
    (0.65)
    6.97
    (1.00)
    Day 1,093 (n=312, 138)
    7.85
    (0.62)
    5.81
    (0.99)
    Day 1,177 (n=273, 125)
    7.67
    (0.68)
    7.02
    (1.07)
    Day 1,261 (n=292, 134)
    8.18
    (0.70)
    6.14
    (1.03)
    Day 1,345 (n=147, 62)
    6.80
    (0.93)
    7.01
    (1.25)
    Day 1,457 (n=290, 129)
    7.75
    (0.70)
    6.51
    (1.01)
    Day 1,625 (n=280, 126)
    6.96
    (0.70)
    7.13
    (1.10)
    Day 1,821 (n=273, 125)
    7.39
    (0.71)
    6.56
    (1.09)
    Day 1,989 (n=118, 55)
    6.58
    (1.08)
    6.65
    (1.57)
    Day 2,185 (n=85, 38)
    5.92
    (1.22)
    7.10
    (1.60)
    94. Secondary Outcome
    Title Mean BL Fatigue in the OL Period
    Description Mean baseline values are reported for each cohort at each time point using the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n=373, 160)
    63.52
    (23.23)
    65.37
    (22.96)
    BL (Day 0) for Day 449 Cohort (n=358, 156)
    63.59
    (23.51)
    65.28
    (23.24)
    BL (Day 0) for Day 533 Cohort (n=353, 157)
    63.25
    (23.57)
    65.78
    (22.89)
    BL (Day 0) for Day 617 Cohort (n=339, 150)
    63.19
    (23.48)
    64.73
    (23.42)
    BL (Day 0) for Day 729 Cohort (n=329, 143)
    63.53
    (23.15)
    64.59
    (23.73)
    BL (Day 0) for Day 813 Cohort (n=318, 141)
    63.77
    (22.77)
    64.81
    (23.59)
    BL (Day 0) for Day 897 Cohort (n=316, 139)
    63.61
    (23.11)
    65.36
    (23.29)
    BL (Day 0) for Day 981 Cohort (n=312, 137)
    63.58
    (22.99)
    65.51
    (23.43)
    BL (Day 0) for Day 1,093 Cohort (n=307, 138)
    63.33
    (23.18)
    65.47
    (23.34)
    BL (Day 0) for Day 1,177 Cohort (n=271, 123)
    64.05
    (22.73)
    65.18
    (23.11)
    BL (Day 0) for Day 1,261 Cohort (n=289, 133)
    63.38
    (23.37)
    65.56
    (23.19)
    BL (Day 0) for Day 1,345 Cohort (n=141, 59)
    65.64
    (21.44)
    69.00
    (20.57)
    BL (Day 0) for Day 1,457 Cohort (n=283, 129)
    63.66
    (23.51)
    65.50
    (23.00)
    BL (Day 0) for Day 1,625 Cohort (n=275, 124)
    63.18
    (23.78)
    66.34
    (22.48)
    BL (Day 0) for Day 1,821 Cohort (n=263, 125)
    62.48
    (23.84)
    65.00
    (23.15)
    BL (Day 0) for Day 1,989 Cohort (n=115, 53)
    64.36
    (23.88)
    67.45
    (22.16)
    BL (Day 0) for Day 2,185 Cohort (n=81, 37)
    64.77
    (22.45)
    70.17
    (19.01)
    95. Secondary Outcome
    Title Mean Change From BL in Fatigue in the OL Period
    Description The mean change from baseline in fatigue was measured on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n=373, 160)
    -28.0
    (1.49)
    -22.6
    (2.21)
    Day 449 (n=358, 156)
    -28.5
    (1.55)
    -31.1
    (2.43)
    Day 533 (n=353, 157)
    -29.4
    (1.51)
    -31.1
    (2.46)
    Day 617 (n=339, 150)
    -30.4
    (1.60)
    -30.5
    (2.54)
    Day 729 (n=329, 143)
    -31.2
    (1.60)
    -30.0
    (2.67)
    Day 813 (n=318, 141)
    -29.9
    (1.60)
    -31.0
    (2.42)
    Day 897 (n=316, 139)
    -29.7
    (1.66)
    -30.6
    (2.45)
    Day 981 (n=312, 137)
    -30.5
    (1.69)
    -31.1
    (2.56)
    Day 1,093 (n=307, 138)
    -32.8
    (1.61)
    -31.3
    (2.53)
    Day 1,177 (n=271, 123)
    -32.2
    (1.83)
    -33.3
    (2.69)
    Day 1,261 (n=289, 133)
    -30.3
    (1.70)
    -31.2
    (2.62)
    Day 1,345 (n=141, 59)
    -33.9
    (2.42)
    -28.2
    (3.80)
    Day 1,457 (n=283, 129)
    -32.2
    (1.65)
    -32.6
    (2.62)
    Day 1,625 (n=275, 124)
    -30.9
    (1.69)
    -32.3
    (2.56)
    Day 1,821 (n=263, 125)
    -30.3
    (1.82)
    -32.0
    (2.65)
    Day 1,989 (n=115, 53)
    -33.6
    (2.80)
    -33.7
    (4.18)
    Day 2,185 (n=81, 37)
    -29.4
    (3.22)
    -35.0
    (4.49)
    96. Secondary Outcome
    Title Mean BL Sleep Quality in the OL Period
    Description Mean baseline values are reported for each cohort at each time point using the Medical Outcomes Study Sleep scale (MOS-sleep [assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n=373, 160)
    42.42
    (19.96)
    43.53
    (19.59)
    BL (Day 0) for Day 449 Cohort (n=358, 156)
    42.77
    (20.07)
    43.22
    (19.64)
    BL (Day 0) for Day 533 Cohort (n=353, 157)
    42.62
    (20.11)
    43.24
    (19.39)
    BL (Day 0) for Day 617 Cohort (n=339, 150)
    42.51
    (20.19)
    43.24
    (19.90)
    BL (Day 0) for Day 729 Cohort (n=329, 143)
    42.28
    (20.01)
    43.97
    (19.75)
    BL (Day 0) for Day 813 Cohort (n=318, 141)
    42.63
    (20.07)
    43.58
    (19.70)
    BL (Day 0) for Day 897 Cohort (n=316, 139)
    42.60
    (20.31)
    43.65
    (19.83)
    BL (Day 0) for Day 981 Cohort (n=312, 137)
    42.51
    (20.25)
    43.58
    (19.78)
    BL (Day 0) for Day 1,093 Cohort (n=307, 138)
    42.69
    (20.36)
    43.78
    (19.84)
    BL (Day 0) for Day 1,177 Cohort (n=270, 124)
    43.08
    (20.28)
    43.51
    (19.52)
    BL (Day 0) for Day 1,261 Cohort (n=289, 133)
    42.87
    (20.40)
    43.76
    (19.83)
    BL (Day 0) for Day 1,345 Cohort (n=141, 59)
    41.78
    (21.79)
    48.39
    (20.23)
    BL (Day 0) for Day 1,457 Cohort (n=275, 124)
    42.93
    (20.82)
    44.14
    (19.74)
    BL (Day 0) for Day 1,625 Cohort (n=272, 122)
    42.70
    (20.46)
    44.51
    (20.00)
    BL (Day 0) for Day 1,821 Cohort (n=263, 125)
    42.04
    (20.53)
    43.59
    (20.00)
    BL (Day 0) for Day 1,989 Cohort (n=115, 53)
    43.15
    (22.33)
    47.62
    (20.33)
    BL (Day 0) for Day 2,185 Cohort (n=81, 37)
    42.70
    (22.06)
    51.43
    (19.75)
    97. Secondary Outcome
    Title Mean Change From BL in Sleep Quality in the OL Period
    Description The mean change from baseline in sleep quality was assessed on the Medical Outcomes Study Sleep scale (MOS-sleep [assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n=373, 160)
    -10.8
    (0.91)
    -7.97
    (1.25)
    Day 449 (n=358, 156)
    -11.0
    (0.97)
    -11.4
    (1.36)
    Day 533 (n=353, 157)
    -11.4
    (0.92)
    -10.9
    (1.42)
    Day 617 (n=339, 150)
    -10.6
    (0.92)
    -11.9
    (1.41)
    Day 729 (n=329, 143)
    -10.9
    (0.99)
    -11.3
    (1.48)
    Day 813 (n=318, 141)
    -10.9
    (1.07)
    -10.8
    (1.57)
    Day 897 (n=316, 139)
    -12.2
    (1.04)
    -12.0
    (1.46)
    Day 981 (n=312, 137)
    -11.4
    (1.05)
    -10.8
    (1.58)
    Day 1,093 (n=307, 138)
    -11.9
    (1.09)
    -11.3
    (1.53)
    Day 1,177 (n=270, 124)
    -11.9
    (1.19)
    -10.8
    (1.61)
    Day 1,261 (n=289, 133)
    -12.2
    (1.16)
    -10.1
    (1.59)
    Day 1,345 (n=141, 59)
    -11.6
    (1.68)
    -12.5
    (2.17)
    Day 1,457 (n=275, 124)
    -11.7
    (1.16)
    -10.4
    (1.62)
    Day 1,625 (n=272, 122)
    -11.2
    (1.19)
    -11.6
    (1.72)
    Day 1,821 (n=263, 125)
    -10.8
    (1.23)
    -9.10
    (1.50)
    Day 1,989 (n=115, 53)
    -11.7
    (1.98)
    -11.0
    (2.40)
    Day 2,185 (n=81, 37)
    -8.76
    (2.03)
    -14.6
    (2.92)
    98. Secondary Outcome
    Title Mean BL Limitations on Activities of Daily Living in the OL Period
    Description Mean baseline values are reported for each cohort at each time point. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    BL (Day 0) for Day 365 Cohort (n=360, 153)
    13.80
    (10.98)
    13.21
    (12.64)
    BL (Day 0) for Day 449 Cohort (n=348, 150)
    13.82
    (10.92)
    13.19
    (12.65)
    BL (Day 0) for Day 533 Cohort (n=338, 148)
    13.91
    (11.06)
    13.55
    (12.70)
    BL (Day 0) for Day 617 Cohort (n=332, 140)
    14.01
    (11.10)
    13.23
    (12.72)
    BL (Day 0) for Day 729 Cohort (n=316, 138)
    13.96
    (11.11)
    13.52
    (12.78)
    BL (Day 0) for Day 813 Cohort (n=306, 133)
    14.31
    (11.14)
    13.38
    (12.88)
    BL (Day 0) for Day 897 Cohort (n=302, 131)
    14.08
    (11.14)
    13.81
    (12.91)
    BL (Day 0) for Day 981 Cohort (n=300, 129)
    14.13
    (11.19)
    13.70
    (13.03)
    BL (Day 0) for Day 1,093 Cohort (n=292, 130)
    14.34
    (11.15)
    13.79
    (12.95)
    BL (Day 0) for Day 1,177 Cohort (n=259, 118)
    14.53
    (11.17)
    13.80
    (13.28)
    BL (Day 0) for Day 1,261 Cohort (n=231, 105)
    15.00
    (11.01)
    13.81
    (13.16)
    BL (Day 0) for Day 1,345 Cohort (n=133, 57)
    15.71
    (11.20)
    15.05
    (11.29)
    BL (Day 0) for Day 1,457 Cohort (n=196, 84)
    15.36
    (11.16)
    14.87
    (13.96)
    99. Secondary Outcome
    Title Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
    Description The mean change from baseline in limitations on activities of daily living in the OL period. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA.
    Time Frame BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    Day 365 (n=360, 153)
    -9.04
    (0.60)
    -6.39
    (1.04)
    Day 449 (n=348, 150)
    -8.75
    (0.58)
    -8.60
    (1.03)
    Day 533 (n=338, 148)
    -9.21
    (0.61)
    -9.00
    (1.12)
    Day 617 (n=332, 140)
    -9.49
    (0.63)
    -8.62
    (1.18)
    Day 729 (n=316, 138)
    -9.55
    (0.62)
    -8.18
    (1.21)
    Day 813 (n=306, 133)
    -9.87
    (0.64)
    -8.67
    (1.19)
    Day 897 (n=302, 131)
    -9.35
    (0.65)
    -9.22
    (1.28)
    Day 981 (n=300, 129)
    -9.48
    (0.66)
    -8.68
    (1.26)
    Day 1,093 (n=292, 130)
    -10.1
    (0.69)
    -8.71
    (1.25)
    Day 1,177 (n=259, 118)
    -10.6
    (0.68)
    -8.39
    (1.34)
    Day 1,261 (n=231, 105)
    -9.96
    (0.73)
    -8.30
    (1.51)
    Day 1,345 (n=133, 57)
    -11.1
    (1.02)
    -9.18
    (1.61)
    Day 1,457 (n=196, 84)
    -9.73
    (0.94)
    -10.3
    (1.61)
    100. Primary Outcome
    Title Mean BL White Blood Cells in the OL Period
    Description Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    White Blood Cells Day 365 (n=365, 157)
    8.78
    (2.83)
    8.81
    (3.01)
    Absolute Neutrophils Day 365 (n=365, 157)
    6.45
    (2.63)
    6.39
    (2.67)
    Absolute Eosinophils Day 365 (n=365, 157)
    0.18
    (0.16)
    0.18
    (0.12)
    Absolute Monocytes Day 365 (n=365, 157)
    0.42
    (0.25)
    0.41
    (0.26)
    White Blood Cells Day 729 (n=328, 143)
    8.89
    (2.87)
    8.73
    (2.96)
    Absolute Neutrophils Day 729 (n=328, 143)
    6.50
    (2.63)
    6.35
    (2.66)
    Absolute Eosinophils Day 729 (n=328, 143)
    0.18
    (0.16)
    0.18
    (0.12)
    Absolute Monocytes Day 729 (n=328, 143)
    0.43
    (0.25)
    0.40
    (0.25)
    White Blood Cells Day 1,093 (n=312, 138)
    8.81
    (2.83)
    8.80
    (3.08)
    Absolute Neutrophils Day 1,093 (n=312, 138)
    6.46
    (2.63)
    6.37
    (2.71)
    Absolute Eosinophils Day 1,093 (n=312, 138)
    0.18
    (0.16)
    0.18
    (0.12)
    Absolute Monocytes Day 1,093 (n=312, 138)
    0.43
    (0.25)
    0.41
    (0.27)
    White Blood Cells Day 1,457 (n=292, 130)
    8.80
    (2.81)
    8.74
    (3.10)
    Absolute Neutrophils Day 1,457 (n=292, 130)
    6.43
    (2.59)
    6.32
    (2.73)
    Absolute Eosinophils Day 1,457 (n=292, 130)
    0.18
    (0.17)
    0.18
    (0.12)
    Absolute Monocytes Day 1,457 (n=292, 130)
    0.43
    (0.25)
    0.40
    (0.25)
    White Blood Cells Day 1,821 (n=262,124)
    8.82
    (2.76)
    8.70
    (3.06)
    Absolute Neutrophils Day 1,821 (n=262,124)
    6.45
    (2.56)
    6.35
    (2.72)
    Absolute Eosinophils Day 1,821 (n=262,124)
    0.18
    (0.16)
    0.18
    (0.12)
    Absolute Monocytes Day 1,821 (n=262,124)
    0.42
    (0.24)
    0.39
    (0.22)
    White Blood Cells Day 1,905 (n=134, 68)
    9.14
    (2.83)
    8.80
    (2.91)
    Absolute Neutrophils Day 1,905 (n=134, 68)
    6.78
    (2.67)
    6.56
    (2.68)
    Absolute Eosinophils Day 1,905 (n=134, 68)
    0.17
    (0.16)
    0.16
    (0.11)
    Absolute Monocytes Day 1,905 (n=134, 68)
    0.37
    (0.21)
    0.34
    (0.19)
    White Blood Cells Day 1,989 (n=121,56)
    9.16
    (2.87)
    8.81
    (2.93)
    Absolute Neutrophils Day 1,989 (n=121,56)
    6.86
    (2.77)
    6.69
    (2.74)
    Absolute Eosinophils Day 1,989 (n=121,56)
    0.15
    (0.14)
    0.15
    (0.10)
    Absolute Monocytes Day 1,989 (n=121,56)
    0.35
    (0.21)
    0.35
    (0.18)
    White Blood Cells Day 2,073 (n=81,38)
    9.64
    (3.05)
    9.22
    (3.12)
    Absolute Neutrophils Day 2,073 (n=81,38)
    7.25
    (2.90)
    6.97
    (2.99)
    Absolute Eosinophils Day 2,073 (n=81,38)
    0.12
    (0.10)
    0.13
    (0.09)
    Absolute Monocytes Day 2,073 (n=81,38)
    0.41
    (0.22)
    0.38
    (0.19)
    White Blood Cells Day 2,185 (n=82,37)
    9.73
    (2.98)
    9.22
    (3.16)
    Absolute Neutrophils Day 2,185 (n=82,37)
    7.35
    (2.84)
    6.93
    (3.03)
    Absolute Eosinophils Day 2,185 (n=82,37)
    0.12
    (0.11)
    0.13
    (0.09)
    Absolute Monocytes Day 2,185 (n=82,37)
    0.40
    (0.22)
    0.38
    (0.20)
    101. Primary Outcome
    Title Mean Change From BL in White Blood Cells in the OL Period
    Description All changes in participant laboratory parameters were monitored on each day of study drug administration.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    White Blood Cells Day 365 (n=365, 157)
    -.10
    (0.13)
    -0.44
    (0.17)
    Absolute Neutrophils Day 365 (n=365, 157)
    -1.20
    (0.12)
    -0.43
    (0.18)
    Absolute Eosinophils Day 365 (n=365, 157)
    -0.02
    (0.01)
    -0.01
    (0.01)
    Absolute Monocytes Day 365 (n=365, 157)
    -0.03
    (0.01)
    -0.03
    (0.02)
    White Blood Cells Day 729 (n=328, 143)
    -1.35
    (0.15)
    -1.19
    (0.20)
    Absolute Neutrophils Day 729 (n=328, 143)
    -1.50
    (0.14)
    -1.49
    (0.19)
    Absolute Eosinophils Day 729 (n=328, 143)
    -0.02
    (0.01)
    -0.04
    (0.01)
    Absolute Monocytes Day 729 (n=328, 143)
    -0.06
    (0.02)
    -0.03
    (0.02)
    White Blood Cells Day 1,093 (n=312, 138)
    -1.50
    (0.16)
    -1.55
    (0.22)
    Absolute Neutrophils Day 1,093 (n=312, 138)
    -1.57
    (0.15)
    -1.66
    (0.22)
    Absolute Eosinophils Day 1,093 (n=312, 138)
    -0.01
    (0.01)
    -0.01
    (0.01)
    Absolute Monocytes Day 1,093 (n=312, 138)
    -0.07
    (0.02)
    -0.08
    (0.02)
    White Blood Cells Day 1,457 (n=292, 130)
    -1.36
    (0.16)
    -1.62
    (0.25)
    Absolute Neutrophils Day 1,457 (n=292, 130)
    -1.44
    (0.15)
    -1.68
    (0.24)
    Absolute Eosinophils Day 1,457 (n=292, 130)
    -0.00
    (0.01)
    0.01
    (0.02)
    Absolute Monocytes Day 1,457 (n=292, 130)
    -0.06
    (0.02)
    -0.07
    (0.02)
    White Blood Cells Day 1,821 (n=262,124)
    -1.56
    (0.18)
    -1.71
    (0.24)
    Absolute Neutrophils Day 1,821 (n=262,124)
    -1.72
    (0.17)
    -1.92
    (0.23)
    Absolute Eosinophils Day 1,821 (n=262,124)
    -0.00
    (0.01)
    0.01
    (0.02)
    Absolute Monocytes Day 1,821 (n=262,124)
    -0.03
    (0.02)
    -0.04
    (0.02)
    White Blood Cells Day 1,905 (n=134, 68)
    -0.82
    (0.38)
    -1.11
    (0.32)
    Absolute Neutrophils Day 1,905 (n=134, 68)
    -1.30
    (0.31)
    -1.53
    (0.33)
    Absolute Eosinophils Day 1,905 (n=134, 68)
    -0.00
    (0.02)
    -0.02
    (0.02)
    Absolute Monocytes Day 1,905 (n=134, 68)
    0.03
    (0.02)
    0.05
    (0.03)
    White Blood Cells Day 1,989 (n=121,56)
    -1.07
    (0.26)
    -0.97
    (0.30)
    Absolute Neutrophils Day 1,989 (n=121,56)
    -.152
    (0.26)
    -1.47
    (0.33)
    Absolute Eosinophils Day 1,989 (n=121,56)
    0.01
    (0.02)
    -0.00
    (0.02)
    Absolute Monocytes Day 1,989 (n=121,56)
    0.03
    (0.02)
    0.03
    (0.03)
    White Blood Cells Day 2,073 (n=81,38)
    -1.00
    (0.33)
    -1.54
    (0.44)
    Absolute Neutrophils Day 2,073 (n=81,38)
    -1.57
    (0.35)
    -2.17
    (0.47)
    Absolute Eosinophils Day 2,073 (n=81,38)
    0.02
    (0.01)
    0.04
    (0.02)
    Absolute Monocytes Day 2,073 (n=81,38)
    0.13
    (0.03)
    0.11
    (0.04)
    White Blood Cells Day 2,185 (n=82,37)
    -1.41
    (0.33)
    -1.96
    (0.39)
    Absolute Neutrophils Day 2,185 (n=82,37)
    -1.78
    (0.33)
    -2.39
    (0.43)
    Absolute Eosinophils Day 2,185 (n=82,37)
    0.03
    (0.02)
    -0.01
    (0.02)
    Absolute Monocytes Day 2,185 (n=82,37)
    0.08
    (0.04)
    0.08
    (0.04)
    102. Primary Outcome
    Title Mean BL Liver Function Parameters in the OL Period
    Description Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    Alkaline Phosphatase Day 365 (n=365, 157)
    99.56
    (37.11)
    98.73
    (41.23)
    Alanine Aminotransferase Day 365 (n=365, 157)
    22.35
    (22.07)
    23.40
    (27.35)
    Aspartate Aminotransferase Day 365 (n=365, 157)
    21.53
    (12.00)
    22.87
    (15.14)
    G-Glutamyl Transferase Day 365 (n=365, 157)
    34.89
    (32.59)
    30.73
    (26.54)
    Alkaline Phosphatase Day 729 (n=328, 143)
    98.30
    (35.22)
    99.49
    (41.24)
    Alanine Aminotransferase Day 729 (n=328, 143)
    22.74
    (22.91)
    23.21
    (28.38)
    Aspartate Aminotransferase Day 729 (n=328, 143)
    21.62
    (12.35)
    22.87
    (15.50)
    G-Glutamyl Transferase Day 729 (n=328, 143)
    35.37
    (33.62)
    28.73
    (19.92)
    Alkaline Phosphatase Day 1,093 (n=312, 138)
    99.18
    (34.95)
    99.43
    (40.80)
    Alanine Aminotransferase Day 1,093 (n=312, 138)
    22.75
    (23.38)
    23.01
    (28.87)
    Aspartate Aminotransferase Day 1,093 (n=312, 138)
    21.60
    (12.55)
    22.91
    (15.69)
    G-Glutamyl Transferase Day 1,093 (n=312, 138)
    34.34
    (29.93)
    28.43
    (20.15)
    Alkaline Phosphatase Day 1,457 (n=292, 130)
    100.8
    (36.04)
    99.75
    (41.90)
    Alanine Aminotransferase Day 1,457 (n=292, 130)
    23.05
    (23.95)
    23.43
    (29.67)
    Aspartate Aminotransferase Day 1,457 (n=292, 130)
    21.88
    (12.84)
    23.29
    (16.08)
    G-Glutamyl Transferase Day 1,457 (n=292, 130)
    35.80
    (34.83)
    28.34
    (20.35)
    Alkaline Phosphatase Day 1,821 (n=262,124)
    99.80
    (34.22)
    97.68
    (33.66)
    Alanine Aminotransferase Day 1,821 (n=262,124)
    23.22
    (24.74)
    23.55
    (30.34)
    Aspartate Aminotransferase Day 1,821 (n=262,124)
    21.63
    (12.98)
    23.50
    (16.37)
    G-Glutamyl Transferase Day 1,821 (n=262,124)
    35.50
    (34.74)
    27.76
    (19.77)
    Alkaline Phosphatase Day 1,905 (n=134, 68)
    97.33
    (35.95)
    92.19
    (35.33)
    Alanine Aminotransferase Day 1,905 (n=134, 68)
    22.57
    (22.33)
    25.65
    (39.19)
    Aspartate Aminotransferase Day 1,905 (n=134, 68)
    21.43
    (12.21)
    24.60
    (20.64)
    G-Glutamyl Transferase Day 1,905 (n=134, 68)
    35.08
    (31.28)
    30.01
    (22.38)
    Alkaline Phosphatase Day 1,989 (n=121,56)
    97.46
    (35.63)
    95.18
    (36.81)
    Alanine Aminotransferase Day 1,989 (n=121,56)
    23.15
    (23.24)
    27.80
    (42.76)
    Aspartate Aminotransferase Day 1,989 (n=121,56)
    21.55
    (12.72)
    25.82
    (22.44)
    G-Glutamyl Transferase Day 1,989 (n=121,56)
    35.27
    (32.43)
    31.39
    (23.44)
    Alkaline Phosphatase Day 2,073 (n=81,38)
    86.87
    (30.05)
    78.53
    (22.77)
    Alanine Aminotransferase Day 2,073 (n=81,38)
    22.34
    (24.62)
    27.50
    (50.75)
    Aspartate Aminotransferase Day 2,073 (n=81,38)
    20.93
    (12.70)
    25.37
    (26.59)
    G-Glutamyl Transferase Day 2,073 (n=81,38)
    35.62
    (37.07)
    30.47
    (21.40)
    Alkaline Phosphatase Day 2,185 (n=82,37)
    87.33
    (30.52)
    78.97
    (22.92)
    Alanine Aminotransferase Day 2,185 (n=82,37)
    22.51
    (24.78)
    27.82
    (51.41)
    Alanine Aminotransferase Day 2,185 (n=82,37)
    20.80
    (12.29)
    25.81
    (26.81)
    G-Glutamyl Transferase Day 2,185 (n=82,37)
    36.23
    (37.42)
    30.46
    (21.69)
    103. Primary Outcome
    Title Mean Change From BL in Liver Function Parameters in the OL Period
    Description All changes in participant laboratory parameters were monitored on each day of study drug administration.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    Alkaline Phosphatase Day 365 (n=365, 157)
    -7.27
    (1.60)
    -10.8
    (2.30)
    Alanine Aminotransferase Day 365 (n=365, 157)
    1.10
    (1.25)
    -2.64
    (2.18)
    Aspartate Aminotransferase Day 365 (n=365, 157)
    1.50
    (0.76)
    -1.42
    (1.20)
    G-Glutamyl Transferase Day 365 (n=365, 157)
    -4.42
    (1.48)
    -2.83
    (1.79)
    Alkaline Phosphatase Day 729 (n=328, 143)
    -13.3
    (1.70)
    -18.8
    (2.85)
    Alanine Aminotransferase Day 729 (n=328, 143)
    0.39
    (1.39)
    -1.69
    (2.38)
    Aspartate Aminotransferase Day 729 (n=328, 143)
    1.30
    (0.83)
    0.47
    (1.43)
    G-Glutamyl Transferase Day 729 (n=328, 143)
    -4.96
    (1.62)
    -3.98
    (1.68)
    Alkaline Phosphatase Day 1,093 (n=312, 138)
    -10.0
    (1.69)
    -13.0
    (2.74)
    Alanine Aminotransferase Day 1,093 (n=312, 138)
    0.81
    (1.40)
    -0.17
    (2.52)
    Aspartate Aminotransferase Day 1,093 (n=312, 138)
    1.11
    (0.85)
    0.07
    (1.39)
    G-Glutamyl Transferase Day 1,093 (n=312, 138)
    -6.81
    (1.55)
    -4.51
    (1.54)
    Alkaline Phosphatase Day 1,457 (n=292, 130)
    -12.4
    (1.73)
    -12.0
    (3.02)
    Alanine Aminotransferase Day 1,457 (n=292, 130)
    1.43
    (2.66)
    -3.11
    (2.57)
    Aspartate Aminotransferase Day 1,457 (n=292, 130)
    1.40
    (1.73)
    -1.82
    (1.40)
    G-Glutamyl Transferase Day 1,457 (n=292, 130)
    -5.15
    (2.35)
    -3.66
    (1.54)
    Alkaline Phosphatase Day 1,821 (n=262,124)
    -14.6
    (1.70)
    -14.7
    (1.99)
    Alanine Aminotransferase Day 1,821 (n=262,124)
    -0.95
    (1.49)
    -0.75
    (2.65)
    Aspartate Aminotransferase Day 1,821 (n=262,124)
    0.14
    (0.85)
    -0.52
    (1.52)
    G-Glutamyl Transferase Day 1,821 (n=262,124)
    -5.63
    (2.04)
    -4.65
    (1.55)
    Alkaline Phosphatase Day 1,905 (n=134, 68)
    -14.9
    (2.82)
    -10.6
    (3.19)
    Alanine Aminotransferase Day 1,905 (n=134, 68)
    -2.35
    (2.03)
    -5.74
    (4.66)
    Aspartate Aminotransferase Day 1,905 (n=134, 68)
    -0.49
    (1.18)
    -3.00
    (2.46)
    G-Glutamyl Transferase Day 1,905 (n=134, 68)
    -6.76
    (3.16)
    -3.09
    (2.91)
    Alkaline Phosphatase Day 1,989 (n=121,56)
    -12.4
    (2.80)
    -13.0
    (3.80)
    Alanine Aminotransferase Day 1,989 (n=121,56)
    -1.41
    (2.04)
    -4.98
    (5.60)
    Aspartate Aminotransferase Day 1,989 (n=121,56)
    0.20
    (1.24)
    -1.71
    (2.98)
    G-Glutamyl Transferase Day 1,989 (n=121,56)
    -3.66
    (3.58)
    -4.00
    (2.95)
    Alkaline Phosphatase Day 2,073 (n=81,38)
    -10.6
    (3.40)
    -4.24
    (3.57)
    Alanine Aminotransferase Day 2,073 (n=81,38)
    -0.56
    (2.82)
    -8.08
    (7.91)
    Aspartate Aminotransferase Day 2,073 (n=81,38)
    0.95
    (1.68)
    -2.37
    (4.26)
    G-Glutamyl Transferase Day 2,073 (n=81,38)
    -10.2
    (4.23)
    -4.92
    (3.49)
    Alkaline Phosphatase Day 2,185 (n=82,37)
    -14.2
    (2.79)
    -7.76
    (3.40)
    Alanine Aminotransferase Day 2,185 (n=82,37)
    -2.56
    (2.84)
    -7.43
    (8.65)
    Alanine Aminotransferase Day 2,185 (n=82,37)
    0.60
    (1.60)
    -1.43
    (4.64)
    G-Glutamyl Transferase Day 2,185 (n=82,37)
    -13.9
    (3.81)
    -4.51
    (2.95)
    104. Primary Outcome
    Title Mean BL Select Laboratory Parameters in the OL Period
    Description Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    Total Bilirubin Day 365 (n=365, 157)
    0.42
    (0.18)
    0.48
    (0.23)
    Blood Urea Nitrogen (BUN) Day 365 (n=365, 157)
    16.05
    (5.19)
    15.09
    (4.41)
    Creatinine Day 365 (n=365, 157)
    0.74
    (0.17)
    0.74
    (0.17)
    Serum Calcium Day 365 (n=365, 157)
    9.26
    (0.44)
    9.26
    (0.50)
    Inorganic Phosphorous Day 365 (n=365, 157)
    3.48
    (0.57)
    3.56
    (0.54)
    Serum Glucose Day 365 (n=365, 157)
    96.63
    (29.30)
    98.78
    (58.76)
    Uric Acid Day 365 (n=365, 157)
    4.80
    (1.45)
    4.83
    (1.50)
    Total Bilirubin Day 729 (n=328, 143)
    0.42
    (0.18)
    0.48
    (0.23)
    BUN Day 729 (n=328, 143)
    16.02
    (5.23)
    15.03
    (4.40)
    Creatinine Day 729 (n=328, 143)
    0.74
    (0.18)
    0.73
    (0.17)
    Serum Calcium Day 729 (n=328, 143)
    9.26
    (0.44)
    9.24
    (0.50)
    Inorganic Phosphorous Day 729 (n=328, 143)
    3.50
    (0.57)
    3.55
    (0.50)
    Serum Glucose Day 729 (n=328, 143)
    97.36
    (30.59)
    98.56
    (60.79)
    Uric Acid Day 729 (n=328, 143)
    4.79
    (1.41)
    4.75
    (1.34)
    Total Bilirubin Day 1,093 (n=312, 138)
    0.42
    (0.18)
    0.48
    (0.22)
    BUN Day 1,093 (n=312, 138)
    -0.36
    (0.26)
    0.00
    (0.40)
    Creatinine Day 1,093 (n=312, 138)
    0.73
    (0.17)
    0.74
    (0.17)
    Serum Calcium Day 1,093 (n=312, 138)
    0.04
    (0.03)
    0.02
    (0.04)
    Inorganic Phosphorous Day 1,093 (n=312, 138)
    0.02
    (0.04)
    0.10
    (0.05)
    Serum Glucose Day 1,093 (n=312, 138)
    96.49
    (29.70)
    97.65
    (61.54)
    Uric Acid Day 1,093 (n=312, 138)
    -0.15
    (0.06)
    -0.32
    (0.09)
    Total Bilirubin Day 1,457 (n=292, 130)
    0.42
    (0.18)
    0.49
    (0.23)
    BUN Day 1,457 (n=292, 130)
    15.86
    (5.28)
    15.02
    (4.36)
    Creatinine Day 1,457 (n=292, 130)
    0.73
    (0.17)
    0.74
    (0.18)
    Serum Calcium Day 1,457 (n=292, 130)
    9.26
    (0.45)
    9.25
    (0.46)
    Inorganic Phosphorous Day 1,457 (n=292, 130)
    3.49
    (0.54)
    3.54
    (0.50)
    Serum Glucose Day 1,457 (n=292, 130)
    95.81
    (28.90)
    95.35
    (55.47)
    Uric Acid Day 1,457 (n=292, 130)
    4.73
    (1.40)
    4.75
    (1.32)
    Total Bilirubin Day Day 1,821 (n=262,124)
    0.42
    (0.18)
    0.50
    (0.23)
    BUN Day 1,821 (n=262,124)
    15.93
    (5.29)
    14.88
    (3.96)
    Creatinine Day 1,821 (n=262,124)
    0.73
    (0.16)
    0.74
    (0.18)
    Serum Calcium Day 1,821 (n=262,124)
    9.25
    (0.45)
    9.25
    (0.46)
    Inorganic Phosphorous Day 1,821 (n=262,124)
    3.49
    (0.53)
    3.54
    (0.51)
    Serum Glucose Day 1,821 (n=262,124)
    96.81
    (30.21)
    98.59
    (64.79)
    Uric Acid Day 1,821 (n=262,124)
    4.66
    (1.29)
    4.68
    (1.31)
    Total Bilirubin Day 1,905 (n=134, 68)
    0.43
    (0.18)
    0.50
    (0.25)
    BUN Day 1,905 (n=134, 68)
    16.15
    (5.74)
    14.77
    (3.78)
    Creatinine Day 1,905 (n=134, 68)
    0.72
    (0.16)
    0.75
    (0.16)
    Serum Calcium Day 1,905 (n=134, 68)
    9.30
    (0.45)
    9.30
    (0.40)
    Inorganic Phosphorous Day 1,905 (n=134, 68)
    3.50
    (0.56)
    3.44
    (0.52)
    Serum Glucose Day 1,905 (n=134, 68)
    96.82
    (31.18)
    101.1
    (74.67)
    Uric Acid Day 1,905 (n=134, 68)
    4.70
    (1.25)
    4.93
    (1.30)
    Total Bilirubin Day 1,989 (n=121,56)
    0.43
    (0.18)
    0.52
    (0.27)
    BUN Day 1,989 (n=121,56)
    16.26
    (5.68)
    15.18
    (3.88)
    Creatinine Day 1,989 (n=121,56)
    0.71
    (0.14)
    0.72
    (0.15)
    Serum Calcium Day 1,989 (n=121,56)
    9.31
    (0.44)
    9.33
    (0.42)
    Inorganic Phosphorous Day 1,989 (n=121,56)
    3.51
    (0.57)
    3.45
    (0.53)
    Serum Glucose Day 1,989 (n=121,56)
    98.59
    (33.41)
    104.80
    (81.64)
    Uric Acid Day 1,989 (n=121,56)
    4.72
    (1.25)
    4.99
    (1.36)
    Total Bilirubin Day 2,073 (n=81,38)
    0.42
    (0.19)
    0.52
    (0.30)
    BUN Day 2,073 (n=81,38)
    16.36
    (5.83)
    15.27
    (3.91)
    Creatinine Day 2,073 (n=81,38)
    0.68
    (0.13)
    0.69
    (0.13)
    Serum Calcium Day 2,073 (n=81,38)
    9.41
    (0.36)
    9.48
    (0.38)
    Inorganic Phosphorous Day 2,073 (n=81,38)
    3.61
    (0.58)
    3.52
    (0.60)
    Serum Glucose Day 2,073 (n=81,38)
    100.4
    (31.96)
    111.1
    (97.97)
    Uric Acid Day 2,073 (n=81,38)
    4.58
    (1.19)
    4.60
    (1.37)
    Total Bilirubin Day 2,185 (n=82,37)
    0.42
    (0.18)
    0.52
    (0.30)
    BUN Day 2,185 (n=82,37)
    16.40
    (5.86)
    15.22
    (3.95)
    Creatinine Day 2,185 (n=82,37)
    0.68
    (0.13)
    0.69
    (0.13)
    Serum Calcium Day 2,185 (n=82,37)
    9.43
    (0.41)
    9.48
    (0.38)
    Inorganic Phosphorous Day 2,185 (n=82,37)
    3.58
    (0.58)
    3.54
    (0.61)
    Serum Glucose Day 2,185 (n=82,37)
    99.29
    (30.71)
    111.4
    (99.31)
    Uric Acid Day 2,185 (n=82,37)
    4.61
    (1.22)
    4.60
    (1.39)
    105. Primary Outcome
    Title Mean Change From BL in Select Laboratory Parameters in the OL Period
    Description All changes in participant laboratory parameters were monitored on each day of study drug administration.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    Total Bilirubin Day 365 (n=365, 157)
    0.06
    (0.01)
    0.00
    (0.01)
    Blood Urea Nitrogen (BUN) Day 365 (n=365, 157)
    16.05
    (5.19)
    15.09
    (4.41)
    Creatinine Day 365 (n=365, 157)
    0.74
    (0.17)
    0.74
    (0.17)
    Serum Calcium Day 365 (n=365, 157)
    0.25
    (0.02)
    0.22
    (0.04)
    Inorganic Phosphorous Day 365 (n=365, 157)
    -0.02
    (0.03)
    -0.12
    (0.04)
    Serum Glucose Day 365 (n=365, 157)
    -1.65
    (1.26)
    -4.06
    (4.29)
    Uric Acid Day 365 (n=365, 157)
    0.04
    (0.05)
    -0.06
    (0.07)
    Total Bilirubin Day 729 (n=328, 143)
    0.09
    (0.01)
    0.05
    (0.02)
    BUN Day 729 (n=328, 143)
    -0.38
    (0.31)
    -0.06
    (0.35)
    Creatinine Day 729 (n=328, 143)
    0.08
    (0.01)
    0.08
    (0.01)
    Serum Calcium Day 729 (n=328, 143)
    0.14
    (0.03)
    0.18
    (0.05)
    Inorganic Phosphorous Day 729 (n=328, 143)
    -0.06
    (0.03)
    -0.10
    (0.05)
    Serum Glucose Day 729 (n=328, 143)
    -1.77
    (1.67)
    -4.74
    (5.18)
    Uric Acid Day 729 (n=328, 143)
    0.11
    (0.06)
    0.00
    (0.09)
    Total Bilirubin Day 1,093 (n=312, 138)
    0.05
    (0.01)
    0.01
    (0.02)
    BUN Day 1,093 (n=312, 138)
    -0.36
    (0.26)
    0.00
    (0.40)
    Creatinine Day 1,093 (n=312, 138)
    -0.00
    (0.01)
    -0.03
    (0.01)
    Serum Calcium Day 1,093 (n=312, 138)
    0.04
    (0.03)
    0.02
    (0.04)
    Inorganic Phosphorous Day 1,093 (n=312, 138)
    0.02
    (0.04)
    0.10
    (0.05)
    Serum Glucose Day 1,093 (n=312, 138)
    0.36
    (1.63)
    -4.95
    (4.84)
    Uric Acid Day 1,093 (n=312, 138)
    -0.15
    (0.06)
    -0.32
    (0.09)
    Total Bilirubin Day 1,457 (n=292, 130)
    0.01
    (0.01)
    -0.04
    (0.02)
    BUN Day 1,457 (n=292, 130)
    -0.48
    (0.27)
    -0.47
    (0.42)
    Creatinine Day 1,457 (n=292, 130)
    0.02
    (0.01)
    -0.03
    (0.01)
    Serum Calcium Day 1,457 (n=292, 130)
    -0.08
    (0.03)
    -0.08
    (0.04)
    Inorganic Phosphorous Day 1,457 (n=292, 130)
    -0.00
    (0.04)
    0.02
    (0.05)
    Serum Glucose Day 1,457 (n=292, 130)
    0.43
    (1.53)
    -0.12
    (5.09)
    Uric Acid Day 1,457 (n=292, 130)
    -0.19
    (0.06)
    -0.43
    (0.09)
    Total Bilirubin Day Day 1,821 (n=262,124)
    0.01
    (0.01)
    -0.01
    (0.04)
    BUN Day 1,821 (n=262,124)
    -0.54
    (0.28)
    0.30
    (0.44)
    Creatinine Day 1,821 (n=262,124)
    -0.01
    (0.01)
    -0.04
    (0.02)
    Serum Calcium Day 1,821 (n=262,124)
    -0.07
    (0.03)
    -0.04
    (0.04)
    Inorganic Phosphorous Day 1,821 (n=262,124)
    0.02
    (0.04)
    0.01
    (0.05)
    Serum Glucose Day 1,821 (n=262,124)
    3.27
    (1.86)
    -0.02
    (5.51)
    Uric Acid Day 1,821 (n=262,124)
    -0.13
    (0.06)
    -0.30
    (0.09)
    Total Bilirubin Day 1,905 (n=134, 68)
    0.01
    (0.02)
    -0.05
    (0.04)
    BUN Day 1,905 (n=134, 68)
    -0.36
    (0.39)
    0.56
    (0.57)
    Creatinine Day 1,905 (n=134, 68)
    -0.04
    (0.01)
    -0.03
    (0.02)
    Serum Calcium Day 1,905 (n=134, 68)
    -0.12
    (0.04)
    -0.11
    (0.05)
    Inorganic Phosphorous Day 1,905 (n=134, 68)
    -0.03
    (0.06)
    0.11
    (0.08)
    Serum Glucose Day 1,905 (n=134, 68)
    3.00
    (2.96)
    -0.50
    (9.71)
    Uric Acid Day 1,905 (n=134, 68)
    -0.29
    (0.09)
    -0.29
    (0.12)
    Total Bilirubin Day 1,989 (n=121,56)
    0.01
    (0.02)
    -0.03
    (0.03)
    BUN Day 1,989 (n=121,56)
    -0.31
    (0.45)
    0.09
    (0.64)
    Creatinine Day 1,989 (n=121,56)
    -0.01
    (0.01)
    -0.02
    (0.02)
    Serum Calcium Day 1,989 (n=121,56)
    -0.10
    (0.04)
    -0.08
    (0.05)
    Inorganic Phosphorous Day 1,989 (n=121,56)
    -0.07
    (0.06)
    0.08
    (0.08)
    Serum Glucose Day 1,989 (n=121,56)
    -1.58
    (2.85)
    -2.70
    (11.88)
    Uric Acid Day 1,989 (n=121,56)
    -0.29
    (0.09)
    -0.38
    (0.14)
    Total Bilirubin Day 2,073 (n=81,38)
    0.04
    (0.02)
    -0.100
    (0.04)
    BUN Day 2,073 (n=81,38)
    0.33
    (0.47)
    0.84
    (0.72)
    Creatinine Day 2,073 (n=81,38)
    0.05
    (0.01)
    0.04
    (0.03)
    Serum Calcium Day 2,073 (n=81,38)
    -0.10
    (0.04)
    -0.20
    (0.08)
    Inorganic Phosphorous Day 2,073 (n=81,38)
    -0.11
    (0.07)
    -0.11
    (0.12)
    Serum Glucose Day 2,073 (n=81,38)
    -0.74
    (3.13)
    -18.2
    (16.92)
    Uric Acid Day 2,073 (n=81,38)
    -0.08
    (0.11)
    -0.15
    (0.16)
    Total Bilirubin Day 2,185 (n=82,37)
    0.05
    (0.02)
    0.00
    (0.04)
    BUN Day 2,185 (n=82,37)
    0.51
    (0.53)
    0.18
    (0.56)
    Creatinine Day 2,185 (n=82,37)
    0.03
    (0.01)
    0.04
    (0.02)
    Serum Calcium Day 2,185 (n=82,37)
    -0.27
    (0.04)
    -0.19
    (0.07)
    Inorganic Phosphorous Day 2,185 (n=82,37)
    -0.14
    (0.07)
    -0.13
    (0.13)
    Serum Glucose Day 2,185 (n=82,37)
    6.85
    (3.81)
    -8.86
    (17.98)
    Uric Acid Day 2,185 (n=82,37)
    -0.12
    (0.10)
    -0.17
    (0.14)
    106. Primary Outcome
    Title Mean BL Serum Electrolytes in the OL Period
    Description Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    Serum Sodium Day 365 (n=365, 157)
    139.9
    (2.89)
    140.7
    (3.03)
    Serum Potassium Day 365 (n=365, 157)
    4.27
    (0.37)
    4.29
    (0.43)
    Serum Chloride Day 365 (n=365, 157)
    104.1
    (3.17)
    105.0
    (3.63)
    Serum Sodium Day 729 (n=328, 143)
    139.8
    (2.97)
    140.7
    (3.06)
    Serum Potassium Day 729 (n=328, 143)
    4.27
    (0.36)
    4.30
    (0.42)
    Serum Chloride Day 729 (n=328, 143)
    103.9
    (3.13)
    104.9
    (3.65)
    Serum Sodium Day 1,093 (n=312, 138)
    139.9
    (2.88)
    140.7
    (3.11)
    Serum Potassium Day 1,093 (n=312, 138)
    4.27
    (0.36)
    4.27
    (0.39)
    Serum Chloride Day 1,093 (n=312, 138)
    104.0
    (3.08)
    104.9
    (3.64)
    Serum Sodium Day 1,457 (n=292, 130)
    139.9
    (2.83)
    140.7
    (3.16)
    Serum Potassium Day 1,457 (n=292, 130)
    4.27
    (0.35)
    4.27
    (0.38)
    Serum Chloride Day 1,457 (n=292, 130)
    104.0
    (3.06)
    105.0
    (3.64)
    Serum Sodium Day 1,821 (n=262,124)
    140.0
    (2.84)
    140.7
    (3.11)
    Serum Potassium Day 1,821 (n=262,124)
    4.26
    (0.36)
    4.28
    (0.40)
    Serum Chloride Day 1,821 (n=262,124)
    104.1
    (3.08)
    104.8
    (3.60)
    Serum Sodium Day 1,905 (n=134, 68)
    139.6
    (3.13)
    140.5
    (3.56)
    Serum Potassium Day 1,905 (n=134, 68)
    4.25
    (0.37)
    4.25
    (0.42)
    Serum Chloride Day 1,905 (n=134, 68)
    103.9
    (3.44)
    104.9
    (4.03)
    Serum Sodium Day 1,989 (n=121,56)
    139.5
    (3.14)
    140.1
    (3.72)
    Serum Potassium Day 1,989 (n=121,56)
    4.27
    (0.41)
    4.24
    (0.43)
    Serum Chloride Day 1,989 (n=121,56)
    103.8
    (3.61)
    104.8
    (4.33)
    Serum Sodium Day 2,073 (n=81,38)
    138.2
    (2.33)
    139.0
    (3.91)
    Serum Potassium Day 2,073 (n=81,38)
    4.31
    (0.44)
    4.27
    (0.48)
    Serum Chloride Day 2,073 (n=81,38)
    102.3
    (2.57)
    103.0
    (4.23)
    Serum Sodium Day 2,185 (n=82,37)
    138.2
    (2.31)
    138.9
    (3.93)
    Serum Potassium Day 2,185 (n=82,37)
    4.30
    (0.43)
    4.28
    (0.49)
    Serum Chloride Day 2,185 (n=82,37)
    102.3
    (2.51)
    102.9
    (4.24)
    107. Primary Outcome
    Title Mean Change From BL in Serum Electrolytes in the OL Period
    Description All changes in participant laboratory parameters were monitored on each day of study drug administration.
    Time Frame BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 378 161
    Serum Sodium Day 365 (n=365, 157)
    -0.42
    (0.17)
    -1.37
    (0.27)
    Serum Potassium Day 365 (n=365, 157)
    -0.01
    (0.02)
    -0.06
    (0.03)
    Serum Chloride Day 365 (n=365, 157)
    0.43
    (0.14)
    -0.21
    (0.25)
    Serum Sodium Day 729 (n=328, 143)
    0.71
    (0.19)
    -0.29
    (0.29)
    Serum Potassium Day 729 (n=328, 143)
    -0.03
    (0.02)
    -0.12
    (0.04)
    Serum Chloride Day 729 (n=328, 143)
    0.63
    (0.17)
    0.15
    (0.27)
    Serum Sodium Day 1,093 (n=312, 138)
    -0.29
    (0.21)
    -1.34
    (0.34)
    Serum Potassium Day 1,093 (n=312, 138)
    -0.05
    (0.02)
    -0.08
    (0.04)
    Serum Chloride Day 1,093 (n=312, 138)
    -0.35
    (0.18)
    -1.17
    (0.31)
    Serum Sodium Day 1,457 (n=292, 130)
    -0.18
    (0.25)
    -0.88
    (0.40)
    Serum Potassium Day 1,457 (n=292, 130)
    -0.03
    (0.03)
    -0.08
    (0.04)
    Serum Chloride Day 1,457 (n=292, 130)
    104.0
    (3.06)
    105.0
    (3.64)
    Serum Sodium Day 1,821 (n=262,124)
    -0.68
    (0.24)
    -1.29
    (0.38)
    Serum Potassium Day 1,821 (n=262,124)
    -0.08
    (0.02)
    -0.15
    (0.04)
    Serum Chloride Day 1,821 (n=262,124)
    -0.19
    (0.22)
    -0.69
    (0.34)
    Serum Sodium Day 1,905 (n=134, 68)
    -0.27
    (0.36)
    -0.75
    (0.54)
    Serum Potassium Day 1,905 (n=134, 68)
    -0.06
    (0.04)
    -0.06
    (0.05)
    Serum Chloride Day 1,905 (n=134, 68)
    0.31
    (0.33)
    -0.15
    (0.53)
    Serum Sodium Day 1,989 (n=121,56)
    -0.02
    (0.40)
    -0.25
    (0.66)
    Serum Potassium Day 1,989 (n=121,56)
    -0.05
    (0.04)
    -0.12
    (0.06)
    Serum Chloride Day 1,989 (n=121,56)
    0.40
    (0.38)
    -0.52
    (0.60)
    Serum Sodium Day 2,073 (n=81,38)
    2.56
    (0.32)
    2.05
    (0.71)
    Serum Potassium Day 2,073 (n=81,38)
    -0.10
    (0.05)
    -0.14
    (0.08)
    Serum Chloride Day 2,073 (n=81,38)
    2.27
    (0.40)
    1.89
    (0.72)
    Serum Sodium Day 2,185 (n=82,37)
    2.76
    (0.34)
    2.24
    (0.68)
    Serum Potassium Day 2,185 (n=82,37)
    -0.11
    (0.05)
    -0.20
    (0.08)
    Serum Chloride Day 2,185 (n=82,37)
    2.95
    (0.40)
    1.81
    (0.72)
    108. Secondary Outcome
    Title Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
    Description Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    BL (Day 0) IL-6 for Day 169 Cohort (n=357, 175)
    36.35
    (43.53)
    39.90
    (54.43)
    BL (Day 0) SIL-2R for Day 169 Cohort (n=370, 171)
    1776
    (946.5)
    1603
    (933.1)
    BL (Day 0) TNF-Alpha for D169 Cohort (n=354,172)
    5.94
    (7.90)
    7.86
    (29.41)
    BL (Day 0) IL-6 for Day 365 Cohort (n=247, 121)
    35.27
    (49.06)
    37.89
    (49.61)
    BL (Day 0) SIL-2R for Day 365 Cohort (n=235, 106)
    1674
    (835.1)
    1601
    (1076)
    BL (Day 0) TNF-Alpha for D365 Cohort (n=246, 119)
    5.55
    (7.84)
    5.46
    (8.63)
    109. Secondary Outcome
    Title Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
    Description The mean change from baseline in potential biomarkers of disease (IL-6, SIL-3R, and TNF-Alpha were determined for all participants.
    Time Frame BL (Day 0), Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    IL-6 Day 169 (n=357, 175)
    -21.0
    (2.24)
    -5.81
    (3.00)
    SIL-2R Day 169 (n=370, 171)
    -519.0
    (32.72)
    -85.5
    (32.78)
    TNF-Alpha Day 169 (n=354, 172)
    -0.82
    (0.72)
    2.27
    (2.49)
    IL-6 Day 365 (n=247, 121)
    -23.4
    (3.08)
    -1.82
    (5.23)
    SIL-2R Day 365(n=235, 106)
    -562
    (40.82)
    -290
    (87.97)
    TNF-Alpha Day 365 (n=246, 119)
    -0.22
    (1.04)
    1.22
    (2.42)
    110. Secondary Outcome
    Title Mean Change From BL in RF in the DB Period
    Description The mean change from baseline in participant rheumatoid factor was determined after 6 months and 1 year of treatment relative to baseline. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB Placebo + MTX DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    BL (Day 0) for Day 169 Cohort (n=308, 126)
    -49.8
    (10.90)
    -18.6
    (10.28)
    BL (Day 0) for Day 365 Cohort (n=281, 104)
    -46.5
    (11.44)
    -5.83
    (22.38)
    111. Secondary Outcome
    Title Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period
    Description Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
    Time Frame BL (Day 0), Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB Placebo + MTX DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    BL (Day 0) E-Selectin for D169 Cohort (n= 256,126)
    85.89
    (72.62)
    85.53
    (68.42)
    BL (Day 0) SICAM-1 for D169 Cohort (n=264, 130)
    444.0
    (398.1)
    426.8
    (323.5)
    BL (Day 0) MMP3 for D169 Cohort (n=362, 183)
    83.37
    (81.53)
    77.22
    (73.72)
    BL (Day 0) E-Selectin fpr D365 Cohort (n=162, 74)
    85.91
    (71.66)
    88.39
    (75.09)
    BL (Day 0) SICAM-1 for D365 Cohort (n=235, 114)
    467.2
    (578.5)
    449.5
    (356.0)
    BL (Day 0) MMP3 for D365 Cohort (n=232, 112)
    79.56
    (78.35)
    64.02
    (59.05)
    112. Secondary Outcome
    Title Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period
    Description The mean change from basline in particpant biomarkers of RA disease (E-Selectin, SICAM-1, and MMP3) after 6 months and 1 year of treatment, relative to baseline, were evaluated.
    Time Frame BL (Day 0), Day 169, Day 365

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB Placebo + MTX DB
    Arm/Group Description Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    Measure Participants 424 214
    E-Selectin Day 169 (n= 256, 126)
    -13.8
    (3.28)
    -6.52
    (4.44)
    SICAM-1 Day 169 (n=264, 130)
    -65.0
    (9.87)
    -42.0
    (17.02)
    MMP3 Day 169 (n=362, 183)
    -37.2
    (2.85)
    -8.03
    (3.88)
    E-Selectin Day 365 (n=162, 74)
    -15.4
    (4.37)
    -9.94
    (5.73)
    SICAM-1 Day 365 (n=235, 114)
    -80.0
    (27.20)
    -43.7
    (16.25)
    MMP3 Day 365 (n=232, 112)
    -41.0
    (4.09)
    -12.1
    (5.01)
    113. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 365

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=369, 160)
    1.68
    (0.63)
    1.70
    (0.58)
    Dressing and Grooming (n=372, 160)
    1.47
    (0.75)
    1.49
    (0.73)
    Arising (n=372, 160)
    1.42
    (0.82)
    1.46
    (0.78)
    Eating (n=372, 160)
    1.63
    (0.97)
    1.68
    (0.84)
    Walking (n=372, 158)
    1.40
    (0.83)
    1.37
    (0.78)
    Hygiene (n=370, 160)
    1.93
    (0.90)
    1.91
    (0.89)
    Reaching (n=370, 160)
    1.94
    (0.86)
    1.97
    (0.80)
    Gripping (n=371, 160)
    1.80
    (0.76)
    1.90
    (0.67)
    Activities (n=369, 160)
    1.87
    (0.79)
    1.86
    (0.82)
    114. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 365

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=369, 160)
    -0.68
    (0.03)
    -0.51
    (0.05)
    Dressing and Grooming (n=372, 160)
    -0.77
    (0.04)
    -0.62
    (0.06)
    Arising (n=372, 160)
    -0.75
    (0.05)
    -0.59
    (0.07)
    Eating (n=372, 160)
    -0.80
    (0.05)
    -0.46
    (0.07)
    Walking (n=372, 158)
    -0.62
    (0.04)
    -0.48
    (0.06)
    Hygiene (n=370, 160)
    -0.54
    (0.05)
    -0.36
    (0.08)
    Reaching (n=370, 160)
    -0.71
    (0.05)
    -0.60
    (0.07)
    Gripping (n=371, 160)
    -0.63
    (0.05)
    -0.49
    (0.07)
    Activities (n=369, 160)
    -0.66
    (0.05)
    -0.47
    (0.07)
    115. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 449

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=366, 157)
    1.69
    (0.64)
    1.71
    (0.59)
    Dressing and Grooming (n=367, 157)
    1.48
    (0.75)
    1.49
    (0.73)
    Arising (n=367, 157)
    1.42
    (0.83)
    1.46
    (0.79)
    Eating (n=367, 157)
    1.64
    (0.97)
    1.67
    (0.84)
    Walking (n=367, 155)
    1.40
    (0.83)
    1.37
    (0.76)
    Hygiene (n=367, 157)
    1.93
    (0.90)
    1.92
    (0.89)
    Reaching (n= 367, 157)
    1.94
    (0.86)
    1.97
    (0.80)
    Gripping (n=368, 157)
    1.81
    (0.75)
    1.90
    (0.67)
    Activities (n=367, 157)
    1.87
    (0.79)
    1.87
    (0.82)
    116. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 449

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=366, 157)
    -0.70
    (0.03)
    -0.71
    (0.05)
    Dressing and Grooming (n=367, 157)
    -0.78
    (0.04)
    -0.85
    (0.06)
    Arising (n=367, 157)
    -0.72
    (0.05)
    -0.86
    (0.07)
    Eating (n=367, 157)
    -0.82
    (0.05)
    -0.63
    (0.07)
    Walking (n=367, 155)
    -0.60
    (0.05)
    -0.61
    (0.06)
    Hygiene (n=367, 157)
    -0.57
    (0.05)
    -0.59
    (0.08)
    Reaching (n= 367, 157)
    -0.75
    (0.05)
    -0.76
    (0.07)
    Gripping (n=368, 157)
    -0.67
    (0.05)
    -0.73
    (0.08)
    Activities (n=367, 157)
    -0.70
    (0.05)
    -0.65
    (0.08)
    117. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 533

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=354, 157)
    1.69
    (0.64)
    1.71
    (0.58)
    Dressing and Grooming (n=355, 156)
    1.47
    (0.75)
    1.49
    (0.73)
    Arising (n=355, 157)
    1.42
    (0.84)
    1.45
    (.078)
    Eating (n=355, 156)
    1.64
    (0.98)
    1.67
    (0.84)
    Walking (n=351, 156)
    1.40
    (0.84)
    1.37
    (0.78)
    Hygiene (n=354, 157)
    1.94
    (0.91)
    1.92
    (0.88)
    Reaching (n=354, 157)
    1.95
    (0.86)
    1.97
    (0.80)
    Gripping (n=354, 157)
    1.81
    (0.76)
    1.91
    (0.66)
    Activities (n=354, 157)
    1.88
    (0.79)
    1.87
    (0.82)
    118. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 533

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=354, 157)
    -0.73
    (0.04)
    -0.73
    (0.05)
    Dressing and Grooming (n=355, 156)
    -0.81
    (0.05)
    -0.85
    (0.06)
    Arising (n=355, 157)
    -0.76
    (0.05)
    -0.86
    (0.07)
    Eating (n=355, 156)
    -0.83
    (0.05)
    -0.74
    (0.07)
    Walking (n=351, 156)
    -0.64
    (0.05)
    -0.69
    (0.07)
    Hygiene (n=354, 157)
    -0.64
    (0.05)
    -0.57
    (0.08)
    Reaching (n=354, 157)
    -0.77
    (0.05)
    -0.57
    (0.08)
    Gripping (n=354, 157)
    -0.68
    (0.05)
    -0.74
    (0.08)
    Activities (n=354, 157)
    -0.70
    (0.05)
    -0.68
    (0.08)
    119. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 617

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=348, 154)
    1.69
    (0.64)
    1.71
    (0.59)
    Dressing and Grooming (n=348, 155)
    1.47
    (0.75)
    1.50
    (0.73)
    Arising (n=348, 155)
    1.42
    (0.84)
    1.46
    (0.79)
    Eating (n=348, 155)
    1.64
    (0.97)
    1.68
    (0.84)
    Walking (n=348, 154)
    1.40
    (0.83)
    1.37
    (0.78)
    Hygiene (n=348, 155)
    1.93
    (0.90)
    1.92
    (0.89)
    Reaching (n=348, 155)
    1.96
    (0.86)
    1.97
    (0.81)
    Gripping (n=348, 154)
    1.82
    (0.75)
    1.91
    (0.67)
    Activities (n=348, 155)
    1.88
    (0.79)
    1.87
    (0.83)
    120. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 617

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=348, 154)
    -0.73
    (0.04)
    -0.74
    (0.06)
    Dressing and Grooming (n=348, 155)
    -0.76
    (0.05)
    -0.82
    (0.07)
    Arising (n=348, 155)
    -0.84
    (0.05)
    -0.81
    (0.07)
    Eating (n=348, 155)
    -0.80
    (0.05)
    -0.75
    (0.07)
    Walking (n=348, 154)
    -0.66
    (0.05)
    -0.67
    (0.07)
    Hygiene (n=348, 155)
    -0.56
    (0.05)
    -0.66
    (0.08)
    Reaching (n=348, 155)
    -0.81
    (0.05)
    -0.80
    (0.08)
    Gripping (n=348, 154)
    -0.75
    (0.05)
    -0.68
    (0.08)
    Activities (n=348, 155)
    -0.71
    (0.05)
    -0.76
    (0.09)
    121. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 729

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=337, 148)
    1.69
    (0.64)
    1.72
    (0.60)
    Dressing and Grooming (n=337, 148)
    1.48
    (0.76)
    1.51
    (0.74)
    Arising (n=338, 148)
    1.41
    (0.83)
    1.45
    (0.79)
    Eating (n= 337, 148)
    1.63
    (0.98)
    1.72
    (0.83)
    Walking (n=338, 147)
    1.41
    (0.84)
    1.37
    (0.78)
    Hygiene (n=338, 148)
    1.93
    (0.89)
    1.93
    (0.89)
    Reaching (n=336, 148)
    1.95
    (0.87)
    1.97
    (0.81)
    Gripping (n=338, 148)
    1.81
    (0.77)
    1.92
    (0.65)
    Activities (n=338, 148)
    1.86
    (0.79)
    1.89
    (0.83)
    122. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 729

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=337, 148)
    -0.74
    (0.04)
    -0.72
    (0.06)
    Dressing and Grooming (n=337, 148)
    -0.82
    (0.05)
    -0.91
    (0.07)
    Arising (n=338, 148)
    -0.80
    (0.05)
    -0.82
    (0.08)
    Eating (n= 337, 148)
    -0.81
    (0.05)
    -0.72
    (0.08)
    Walking (n=338, 147)
    -0.68
    (0.05)
    -0.63
    (0.07)
    Hygiene (n=338, 148)
    -0.53
    (0.05)
    -0.62
    (0.09)
    Reaching (n=336, 148)
    -0.79
    (0.05)
    -0.73
    (0.08)
    Gripping (n=338, 148)
    -0.75
    (0.05)
    -0.62
    (0.08)
    Activities (n=338, 148)
    -0.72
    (0.05)
    -0.72
    (0.09)
    123. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 813

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=325, 146)
    1.70
    (0.64)
    1.72
    (0.60)
    Dressing and Grooming (n=325, 147)
    1.48
    (0.75)
    1.51
    (0.74)
    Arising (n=325, 147)
    1.42
    (0.83)
    1.46
    (0.80)
    Eating (n=325, 147)
    1.65
    (0.98)
    1.70
    (0.83)
    Walking (n=324, 146)
    1.42
    (0.83)
    1.38
    (0.78)
    Hygiene (n=325, 146)
    1.95
    (0.89)
    1.94
    (0.90)
    Reaching (n=324, 146)
    1.97
    (0.87)
    1.97
    (0.82)
    Gripping (n=325, 146)
    1.81
    (0.77)
    1.92
    (0.66)
    Activities (n=324, 146)
    1.87
    (0.79)
    1.87
    (0.84)
    124. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 813

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=325, 146)
    -0.77
    (0.04)
    -0.71
    (0.06)
    Dressing and Grooming (n=325, 147)
    -0.82
    (0.06)
    -0.87
    (0.07)
    Arising (n=325, 147)
    -0.80
    (0.05)
    -0.78
    (0.08)
    Eating (n=325, 147)
    -0.88
    (0.06)
    -0.72
    (0.08)
    Walking (n=324, 146)
    -0.69
    (0.05)
    -0.66
    (0.07)
    Hygiene (n=325, 146)
    -0.58
    (0.06)
    -0.53
    (0.09)
    Reaching (n=324, 146)
    -0.85
    (0.05)
    -0.72
    (0.08)
    Gripping (n=325, 146)
    -0.76
    (0.05)
    -0.77
    (0.08)
    Activities (n=324, 146)
    -0.76
    (0.05)
    -0.71
    (0.08)
    125. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 897

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=318, 140)
    1.69
    (0.64)
    1.72
    (0.60)
    Dressing and Grooming (n=319, 140)
    1.47
    (0.76)
    1.52
    (0.75)
    Arising (n=319, 140)
    1.43
    (0.84)
    1.46
    (0.80)
    Eating (n=319, 140)
    1.63
    (0.99)
    1.71
    (0.84)
    Walking (n=319, 138)
    1.41
    (0.84)
    1.38
    (0.79)
    Hygiene (n=319, 140)
    1.95
    (0.90)
    1.94
    (0.90)
    Reaching (n=319, 140)
    1.96
    (0.87)
    2.01
    (0.80)
    Gripping (n=319, 140)
    1.80
    (0.76)
    1.92
    (0.67)
    Activities (n=319, 140)
    1.87
    (0.79)
    1.87
    (0.85)
    126. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 897

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=318, 140)
    -0.76
    (0.04)
    -0.74
    (0.06)
    Dressing and Grooming (n=319, 140)
    -0.86
    (0.05)
    -0.90
    (0.08)
    Arising (n=319, 140)
    -0.81
    (0.05)
    -0.87
    (0.07)
    Eating (n=319, 140)
    -0.88
    (0.05)
    -0.78
    (0.08)
    Walking (n=319, 138)
    -0.69
    (0.05)
    -0.67
    (0.07)
    Hygiene (n=319, 140)
    -0.60
    (0.06)
    -0.54
    (0.09)
    Reaching (n=319, 140)
    -0.82
    (0.06)
    -0.74
    (0.08)
    Gripping (n=319, 140)
    -0.74
    (0.06)
    -0.74
    (0.08)
    Activities (n=319, 140)
    -0.69
    (0.05)
    -0.71
    (0.09)
    127. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 981

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=312, 137)
    1.69
    (0.65)
    1.72
    (0.60)
    Dressing and Grooming (n=312, 137)
    1.47
    (0.76)
    1.52
    (0.75)
    Arising (n=312, 137)
    1.42
    (0.84)
    1.45
    (0.79)
    Eating (n=312, 137)
    1.63
    (0.99)
    1.70
    (0.83)
    Walking (n=308, 136)
    1.41
    (0.84)
    1.37
    (0.79)
    Hygiene (n=312, 137)
    1.94
    (0.89)
    1.93
    (0.90)
    Reaching (n=312, 137)
    1.97
    (0.86)
    1.99
    (0.80)
    Gripping (n=312, 137)
    1.80
    (0.78)
    1.92
    (0.68)
    Activities (n=312, 137)
    1.87
    (0.79)
    1.85
    (0.84)
    128. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 981

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=312, 137)
    -0.74
    (0.04)
    -0.69
    (0.06)
    Dressing and Grooming (n=312, 137)
    -0.80
    (0.05)
    -0.86
    (0.08)
    Arising (n=312, 137)
    -0.82
    (0.05)
    -0.77
    (0.08)
    Eating (n=312, 137)
    -0.84
    (0.06)
    -0.64
    (0.08)
    Walking (n=308, 136)
    -0.66
    (0.05)
    -0.63
    (0.08)
    Hygiene (n=312, 137)
    -0.54
    (0.06)
    -0.49
    (0.09)
    Reaching (n=312, 137)
    -0.82
    (0.05)
    -0.75
    (0.09)
    Gripping (n=312, 137)
    -0.68
    (0.06)
    -0.74
    (0.08)
    Activities (n=312, 137)
    -0.74
    (0.05)
    -0.64
    (0.09)
    129. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,093

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=308, 137)
    1.69
    (0.64)
    1.72
    (0.60)
    Dressing and Grooming (n=310, 138)
    1.47
    (0.75)
    1.51
    (0.75)
    Arising (n=309, 138)
    1.41
    (0.84)
    1.45
    (0.79)
    Eating (n=309, 138)
    1.62
    (0.98)
    1.69
    (0.84)
    Walking (n=308, 137)
    1.41
    (0.83)
    1.36
    (0.78)
    Hygiene (n=310, 137)
    1.94
    (0.89)
    1.92
    (0.90)
    Reaching (n=310, 137)
    1.96
    (0.87)
    1.99
    (0.80)
    Gripping (n=310, 137)
    1.79
    (0.77)
    1.92
    (0.68)
    Activities (n=310, 137)
    1.87
    (0.79)
    1.85
    (0.84)
    130. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,093

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=308, 137)
    -0.74
    (0.04)
    -0.76
    (0.06)
    Dressing and Grooming (n=310, 138)
    -0.80
    (0.05)
    -0.91
    (0.07)
    Arising (n=309, 138)
    -0.82
    (0.05)
    -0.87
    (0.08)
    Eating (n=309, 138)
    -0.81
    (0.06)
    -0.70
    (0.08)
    Walking (n=308, 137)
    -0.70
    (0.05)
    -0.69
    (0.08)
    Hygiene (n=310, 137)
    -0.58
    (0.05)
    -0.59
    (0.09)
    Reaching (n=310, 137)
    -0.79
    (0.05)
    -0.81
    (0.08)
    Gripping (n=310, 137)
    -0.71
    (0.06)
    -0.74
    (0.08)
    Activities (n=310, 137)
    -0.71
    (0.05)
    -0.73
    (0.09)
    131. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,177

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=274, 125)
    1.69
    (0.63)
    1.71
    (0.61)
    Dressing and Grooming (n=274, 125)
    1.47
    (0.76)
    1.53
    (0.77)
    Arising (n=274, 125)
    1.39
    (0.81)
    1.45
    (0.80)
    Eating (n=274, 125)
    1.68
    (0.97)
    1.70
    (0.85)
    Walking (n=272, 122)
    1.37
    (0.83)
    1.37
    (0.78)
    Hygiene (n=275, 124)
    1.94
    (0.89)
    1.90
    (0.91)
    Reaching (n=275, 125)
    1.96
    (0.85)
    1.99
    (0.80)
    Gripping (n=275, 125)
    1.83
    (0.75)
    1.91
    (0.68)
    Activities (n=275, 125)
    1.87
    (0.80)
    1.85
    (0.86)
    132. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,177

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=274, 125)
    -0.76
    (0.04)
    -0.74
    (0.07)
    Dressing and Grooming (n=274, 125)
    -0.82
    (0.05)
    -0.86
    (0.09)
    Arising (n=274, 125)
    -0.74
    (0.06)
    -0.79
    (0.09)
    Eating (n=274, 125)
    -0.92
    (0.06)
    -0.74
    (0.09)
    Walking (n=272, 122)
    -0.63
    (0.06)
    -0.66
    (0.08)
    Hygiene (n=275, 124)
    -0.57
    (0.06)
    -0.48
    (0.10)
    Reaching (n=275, 125)
    -0.82
    (0.06)
    -0.84
    (0.09)
    Gripping (n=275, 125)
    -0.80
    (0.06)
    -0.80
    (0.09)
    Activities (n=275, 125)
    -0.75
    (0.06)
    -0.76
    (0.10)
    133. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,261

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=292, 134)
    1.69
    (0.65)
    1.70
    (0.60)
    Dressing and Grooming (n=292, 135)
    1.47
    (0.77)
    1.51
    (0.75)
    Arising (n=292, 135)
    1.42
    (0.85)
    1.44
    (0.79)
    Eating (n=292, 135)
    1.64
    (1.00)
    1.69
    (0.83)
    Walking (n=290, 134)
    1.40
    (0.83)
    1.36
    (0.79)
    Hygiene (n=292, 134)
    1.96
    (0.90)
    1.92
    (0.90)
    Reaching (n=292, 134)
    1.97
    (0.87)
    1.97
    (0.79)
    Gripping (n=292, 134)
    1.79
    (0.77)
    1.91
    (0.68)
    Activities (n=292, 133)
    1.87
    (0.81)
    1.83
    (0.85)
    134. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,261

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=292, 134)
    -0.74
    (0.04)
    -0.73
    (0.06)
    Dressing and Grooming (n=292, 135)
    -0.81
    (0.05)
    -0.91
    (0.08)
    Arising (n=292, 135)
    -0.82
    (0.05)
    -0.82
    (0.08)
    Eating (n=292, 135)
    -0.85
    (0.06)
    -0.73
    (0.08)
    Walking (n=290, 134)
    -0.66
    (0.06)
    -0.63
    (0.08)
    Hygiene (n=292, 134)
    -0.52
    (0.06)
    -0.54
    (0.09)
    Reaching (n=292, 134)
    -0.83
    (0.06)
    -0.80
    (0.09)
    Gripping (n=292, 134)
    -0.68
    (0.06)
    -0.70
    (0.09)
    Activities (n=292, 133)
    -0.75
    (0.05)
    -0.68
    (0.10)
    135. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,345

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=152, 62)
    1.65
    (0.63)
    1.73
    (0.58)
    Dressing and Grooming (n=152, 62)
    1.45
    (0.73)
    1.50
    (0.70)
    Arising (n=152, 62)
    1.34
    (0.79)
    1.44
    (0.74)
    Eating (n=152, 62)
    1.63
    (0.97)
    1.69
    (0.84)
    Walking (n=151, 62)
    1.32
    (0.80)
    1.35
    (0.79)
    Hygiene (n=152, 62)
    1.82
    (0.89)
    2.05
    (0.86)
    Reaching (n=152, 62)
    1.98
    (0.82)
    2.06
    (0.74)
    Gripping (n=152, 62)
    1.77
    (0.74)
    1.94
    (0.60)
    Activities (n=152, 62)
    1.88
    (0.79)
    1.79
    (0.77)
    136. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,345

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=152, 62)
    -0.69
    (0.06)
    -0.73
    (0.09)
    Dressing and Grooming (n=152, 62)
    -0.74
    (0.07)
    -0.81
    (0.11)
    Arising (n=152, 62)
    -0.68
    (0.08)
    -0.84
    (0.12)
    Eating (n=152, 62)
    -0.84
    (0.08)
    -0.68
    (0.13)
    Walking (n=151, 62)
    -0.61
    (0.07)
    -0.60
    (0.13)
    Hygiene (n=152, 62)
    -0.46
    (0.09)
    -0.71
    (0.13)
    Reaching (n=152, 62)
    -0.84
    (0.08)
    -0.76
    (0.13)
    Gripping (n=152, 62)
    -0.63
    (0.08)
    -0.82
    (0.11)
    Activities (n=152, 62)
    -0.73
    (0.08)
    -0.60
    (0.12)
    137. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,457

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=289, 129)
    1.70
    (0.65)
    1.71
    (0.60)
    Dressing and Grooming (n=289, 129)
    1.48
    (0.76)
    1.51
    (0.74)
    Arising (n=289, 129)
    1.43
    (0.85)
    1.44
    (0.78)
    Eating (n=289, 129)
    1.64
    (1.00)
    1.70
    (0.83)
    Walking (n=287, 126)
    1.42
    (0.83)
    1.37
    (0.78)
    Hygiene (n=289, 129)
    1.95
    (0.89)
    1.91
    (0.91)
    Reaching (n=289, 129)
    1.97
    (0.86)
    1.99
    (0.79)
    Gripping (n=289, 129)
    1.80
    (0.77)
    1.91
    (0.69)
    Activities (n=289, 129)
    1.88
    (0.80)
    1.84
    (0.84)
    138. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,457

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=289, 129)
    -0.77
    (0.04)
    -0.74
    (0.06)
    Dressing and Grooming (n=289, 129)
    -0.85
    (0.06)
    -0.91
    (0.08)
    Arising (n=289, 129)
    -0.80
    (0.05)
    -0.82
    (0.08)
    Eating (n=289, 129)
    -0.89
    (0.06)
    -0.81
    (0.08)
    Walking (n=287, 126)
    -0.68
    (0.05)
    -0.63
    (0.08)
    Hygiene (n=289, 129)
    -0.57
    (0.06)
    -0.59
    (0.10)
    Reaching (n=289, 129)
    -0.84
    (0.06)
    -0.76
    (0.09)
    Gripping (n=289, 129)
    -0.77
    (0.06)
    -0.71
    (0.09)
    Activities (n=289, 129)
    -0.77
    (0.06)
    -0.74
    (0.09)
    139. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,625

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=280, 126)
    1.69
    (0.65)
    1.72
    (0.59)
    Dressing and Grooming (n=280, 126)
    1.46
    (0.77)
    1.52
    (0.73)
    Arising (n=280, 126)
    1.42
    (0.85)
    1.45
    (0.75)
    Eating (n=280, 126)
    1.63
    (0.99)
    1.69
    (0.83)
    Walking (n=279, 125)
    1.43
    (0.84)
    1.37
    (0.78)
    Hygiene (n=280, 126)
    1.94
    (0.90)
    1.93
    (0.89)
    Reaching (n=280, 126)
    1.96
    (0.85)
    2.00
    (0.78)
    Gripping (n=280, 126)
    1.80
    (0.77)
    1.93
    (0.67)
    Activities (n=280, 126)
    1.88
    (0.80)
    1.87
    (0.83)
    140. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,625

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=280, 126)
    -0.76
    (0.04)
    -0.78
    (0.06)
    Dressing and Grooming (n=280, 126)
    -0.84
    (0.06)
    -0.98
    (0.08)
    Arising (n=280, 126)
    -0.79
    (0.06)
    -0.84
    (0.08)
    Eating (n=280, 126)
    -0.83
    (0.06)
    -0.79
    (0.09)
    Walking (n=279, 125)
    -0.70
    (0.06)
    -0.74
    (0.08)
    Hygiene (n=280, 126)
    -0.56
    (0.06)
    -0.57
    (0.10)
    Reaching (n=280, 126)
    -0.83
    (0.06)
    -0.81
    (0.09)
    Gripping (n=280, 126)
    -0.80
    (0.06)
    -0.76
    (0.09)
    Activities (n=280, 126)
    -0.78
    (0.06)
    -0.76
    (0.09)
    141. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,821

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=273, 125)
    1.69
    (0.65)
    1.69
    (0.60)
    Dressing and Grooming (n=273, 125)
    1.47
    (0.77)
    1.49
    (0.74)
    Arising (n=273, 125)
    1.41
    (0.83)
    1.42
    (0.76)
    Eating (n=273, 124)
    1.63
    (1.00)
    1.67
    (0.83)
    Walking (n=271, 122)
    1.43
    (0.84)
    1.34
    (0.78)
    Hygiene (n=273, 125)
    1.93
    (0.90)
    1.88
    (0.91)
    Reaching (n=273, 125)
    1.97
    (0.86)
    1.97
    (0.78)
    Gripping (n=273, 125)
    1.79
    (0.78)
    1.90
    (0.70)
    Activities (n=273, 125)
    1.88
    (0.81)
    1.82
    (0.85)
    142. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,821

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=273, 125)
    -0.77
    (0.44)
    -0.72
    (0.06)
    Dressing and Grooming (n=273, 125)
    -0.82
    (0.06)
    -0.86
    (0.08)
    Arising (n=273, 125)
    -0.83
    (0.06)
    -0.90
    (0.08)
    Eating (n=273, 124)
    -0.86
    (0.07)
    -0.78
    (0.09)
    Walking (n=271, 122)
    -0.68
    (0.06)
    -0.61
    (0.08)
    Hygiene (n=273, 125)
    -0.56
    (0.07)
    -0.53
    (0.10)
    Reaching (n=273, 125)
    -0.83
    (0.06)
    -0.74
    (0.09)
    Gripping (n=273, 125)
    -0.79
    (0.06)
    -0.80
    (0.09)
    Activities (n=273, 125)
    -0.76
    (0.06)
    -0.61
    (0.09)
    143. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,989

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=119, 55)
    1.72
    (0.61)
    1.67
    (0.62)
    Dressing and Grooming (n=119, 55)
    1.51
    (0.72)
    1.49
    (0.69)
    Arising (n=119, 55)
    1.36
    (0.78)
    1.38
    (0.78)
    Eating (n=119, 55)
    1.66
    (0.99)
    1.62
    (0.85)
    Walking (n=117, 54)
    1.45
    (0.79)
    1.30
    (0.84)
    Hygiene (n=119, 55)
    1.87
    (0.94)
    1.89
    (0.92)
    Reaching (n=119, 55)
    2.08
    (0.81)
    1.98
    (0.76)
    Gripping (n=119, 55)
    1.85
    (0.74)
    1.87
    (0.67)
    Activities (n=119, 55)
    1.97
    (0.81)
    1.84
    (0.74)
    144. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 1,989

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=119, 55)
    -0.81
    (0.07)
    -0.70
    (0.10)
    Dressing and Grooming (n=119, 55)
    -0.84
    (0.09)
    -0.76
    (0.11)
    Arising (n=119, 55)
    -0.86
    (0.08)
    -0.84
    (0.12)
    Eating (n=119, 55)
    -0.83
    (0.10)
    -0.62
    (0.14)
    Walking (n=117, 54)
    -0.77
    (0.09)
    -0.67
    (0.12)
    Hygiene (n=119, 55)
    -0.56
    (0.11)
    -0.58
    (0.13)
    Reaching (n=119, 55)
    -0.89
    (0.10)
    -0.75
    (0.14)
    Gripping (n=119, 55)
    -0.88
    (0.10)
    -0.67
    (0.12)
    Activities (n=119, 55)
    -0.84
    (0.10)
    -0.71
    (0.13)
    145. Secondary Outcome
    Title Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=85, 38)
    1.73
    (0.55)
    1.69
    (0.49)
    Dressing and Grooming (n=85, 37)
    1.54
    (0.70)
    1.54
    (0.65)
    Arising (n=85, 38)
    1.36
    (0.72)
    1.37
    (0.59)
    Eating (n=85, 38)
    1.64
    (0.96)
    1.58
    (0.79)
    Walking (n=84, 38)
    1.39
    (0.73)
    1.37
    (0.71)
    Hygiene (n=85, 38)
    1.86
    (0.91)
    1.97
    (0.82)
    Reaching (n=85, 38)
    2.11
    (0.79)
    2.03
    (0.68)
    Gripping (n=85, 38)
    1.86
    (0.73)
    1.84
    (0.55)
    Activities (n=85, 38)
    2.04
    (0.70)
    1.84
    (0.59)
    146. Secondary Outcome
    Title Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period
    Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
    Time Frame BL (Day 0), Day 2,185

    Outcome Measure Data

    Analysis Population Description
    All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
    Arm/Group Title ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
    Measure Participants 376 160
    HAQ DI (n=85, 38)
    -0.70
    (0.08)
    -0.68
    (0.10)
    Dressing and Grooming (n=85, 37)
    -0.68
    (0.10)
    -0.78
    (0.13)
    Arising (n=85, 38)
    -0.66
    (0.11)
    -0.82
    (0.12)
    Eating (n=85, 38)
    -0.82
    (0.11)
    -0.74
    (0.16)
    Walking (n=84, 38)
    -0.67
    (0.11)
    -0.58
    (0.14)
    Hygiene (n=85, 38)
    -0.55
    (0.13)
    -0.68
    (0.15)
    Reaching (n=85, 38)
    -0.88
    (0.12)
    -0.66
    (0.17)
    Gripping (n=85, 38)
    -0.64
    (0.11)
    -0.47
    (0.12)
    Activities (n=85, 38)
    -0.68
    (0.10)
    -0.68
    (0.13)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title ABA + MTX OL ABA + MTX DB MTX + Placebo DB
    Arm/Group Description Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period. Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
    All Cause Mortality
    ABA + MTX OL ABA + MTX DB MTX + Placebo DB
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    ABA + MTX OL ABA + MTX DB MTX + Placebo DB
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 215/539 (39.9%) 68/433 (15.7%) 27/219 (12.3%)
    Blood and lymphatic system disorders
    ANAEMIA 4/539 (0.7%) 1/433 (0.2%) 0/219 (0%)
    HAEMORRHAGIC ANAEMIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    DISSEMINATED INTRAVASCULAR COAGULATION 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    Cardiac disorders
    ARRHYTHMIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    BRADYCARDIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    CARDIAC ARREST 3/539 (0.6%) 0/433 (0%) 0/219 (0%)
    ANGINA UNSTABLE 2/539 (0.4%) 1/433 (0.2%) 0/219 (0%)
    CARDIAC FAILURE 1/539 (0.2%) 1/433 (0.2%) 1/219 (0.5%)
    CARDIOGENIC SHOCK 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ATRIAL FIBRILLATION 0/539 (0%) 0/433 (0%) 1/219 (0.5%)
    MYOCARDIAL ISCHAEMIA 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    PERICARDIAL EFFUSION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    MYOCARDIAL INFARCTION 4/539 (0.7%) 1/433 (0.2%) 0/219 (0%)
    TACHYCARDIA PAROXYSMAL 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    CORONARY ARTERY DISEASE 2/539 (0.4%) 1/433 (0.2%) 0/219 (0%)
    VENTRICULAR FIBRILLATION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    CARDIAC FAILURE CONGESTIVE 0/539 (0%) 0/433 (0%) 1/219 (0.5%)
    SUPRAVENTRICULAR TACHYCARDIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ATRIOVENTRICULAR BLOCK COMPLETE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    Eye disorders
    CATARACT 3/539 (0.6%) 0/433 (0%) 1/219 (0.5%)
    STRABISMUS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    VITREOUS DETACHMENT 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    Gastrointestinal disorders
    VOMITING 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    DIARRHOEA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    GASTRITIS 1/539 (0.2%) 0/433 (0%) 1/219 (0.5%)
    PERITONITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    CONSTIPATION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    HAEMORRHOIDS 0/539 (0%) 0/433 (0%) 1/219 (0.5%)
    OESOPHAGITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PEPTIC ULCER 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    RECTAL POLYP 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ENTEROCOLITIS 1/539 (0.2%) 0/433 (0%) 1/219 (0.5%)
    ABDOMINAL PAIN 2/539 (0.4%) 0/433 (0%) 1/219 (0.5%)
    ABDOMINAL HERNIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ANAL HAEMORRHAGE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    GASTRODUODENITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    UMBILICAL HERNIA 3/539 (0.6%) 2/433 (0.5%) 0/219 (0%)
    COLITIS ULCERATIVE 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    RECTAL HAEMORRHAGE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ABDOMINAL DISCOMFORT 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ABDOMINAL PAIN UPPER 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    HAEMORRHOIDAL HAEMORRHAGE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    RETROPERITONEAL HAEMORRHAGE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ABDOMINAL HERNIA OBSTRUCTIVE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    GASTROINTESTINAL HAEMORRHAGE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    SMALL INTESTINAL OBSTRUCTION 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    ABDOMINAL STRANGULATED HERNIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    GASTROOESOPHAGEAL REFLUX DISEASE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    MESENTERIC VASCULAR INSUFFICIENCY 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    General disorders
    PYREXIA 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    CHEST PAIN 5/539 (0.9%) 1/433 (0.2%) 0/219 (0%)
    IMPAIRED HEALING 3/539 (0.6%) 1/433 (0.2%) 0/219 (0%)
    HERNIA OBSTRUCTIVE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    MULTI-ORGAN FAILURE 0/539 (0%) 0/433 (0%) 1/219 (0.5%)
    Hepatobiliary disorders
    CHOLELITHIASIS 6/539 (1.1%) 1/433 (0.2%) 0/219 (0%)
    BILE DUCT STONE 3/539 (0.6%) 0/433 (0%) 0/219 (0%)
    CHOLECYSTITIS ACUTE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    CHOLECYSTITIS CHRONIC 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    Infections and infestations
    SEPSIS 1/539 (0.2%) 1/433 (0.2%) 1/219 (0.5%)
    ABSCESS 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    CYSTITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    RHINITIS 0/539 (0%) 0/433 (0%) 1/219 (0.5%)
    PNEUMONIA 7/539 (1.3%) 4/433 (0.9%) 1/219 (0.5%)
    SINUSITIS 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    BRONCHITIS 4/539 (0.7%) 0/433 (0%) 0/219 (0%)
    CELLULITIS 5/539 (0.9%) 1/433 (0.2%) 1/219 (0.5%)
    ERYSIPELAS 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    PARONYCHIA 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    ABSCESS JAW 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    BACTERAEMIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PHARYNGITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ABSCESS LIMB 1/539 (0.2%) 0/433 (0%) 1/219 (0.5%)
    APPENDICITIS 1/539 (0.2%) 0/433 (0%) 1/219 (0.5%)
    SEPTIC SHOCK 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    TUBERCULOSIS 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    DACRYOCYSTITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    DIVERTICULITIS 1/539 (0.2%) 2/433 (0.5%) 0/219 (0%)
    LUNG INFECTION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PYELONEPHRITIS 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    GASTROENTERITIS 2/539 (0.4%) 1/433 (0.2%) 0/219 (0%)
    LOBAR PNEUMONIA 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    NASOPHARYNGITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    WOUND INFECTION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    BRONCHOPNEUMONIA 0/539 (0%) 2/433 (0.5%) 0/219 (0%)
    DOUGLAS' ABSCESS 0/539 (0%) 0/433 (0%) 1/219 (0.5%)
    HERPES DERMATITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ESCHERICHIA SEPSIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PERIRECTAL ABSCESS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ARTHRITIS BACTERIAL 1/539 (0.2%) 1/433 (0.2%) 0/219 (0%)
    LOCALISED INFECTION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    OSTEOMYELITIS ACUTE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PERINEPHRIC ABSCESS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PYELONEPHRITIS ACUTE 1/539 (0.2%) 1/433 (0.2%) 0/219 (0%)
    SUBCUTANEOUS ABSCESS 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    TUBERCULOUS PLEURISY 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    SOFT TISSUE INFECTION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ABDOMINAL WALL ABSCESS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ENDOCARDITIS BACTERIAL 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    HERPES VIRUS INFECTION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PULMONARY TUBERCULOSIS 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    INCISION SITE INFECTION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    URINARY TRACT INFECTION 5/539 (0.9%) 2/433 (0.5%) 0/219 (0%)
    POST PROCEDURAL INFECTION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    RESPIRATORY TRACT INFECTION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    CLOSTRIDIUM DIFFICILE COLITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    POSTOPERATIVE WOUND INFECTION 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    STAPHYLOCOCCAL SKIN INFECTION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    BRONCHOPULMONARY ASPERGILLOSIS 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    LOWER RESPIRATORY TRACT INFECTION 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    UPPER RESPIRATORY TRACT INFECTION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ESCHERICHIA URINARY TRACT INFECTION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    Injury, poisoning and procedural complications
    FALL 3/539 (0.6%) 0/433 (0%) 0/219 (0%)
    OVERDOSE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    EYE INJURY 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    HIP FRACTURE 3/539 (0.6%) 0/433 (0%) 0/219 (0%)
    FOOT FRACTURE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ULNA FRACTURE 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    ANKLE FRACTURE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    FEMUR FRACTURE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    GUN SHOT WOUND 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    WRIST FRACTURE 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    MENISCUS LESION 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    PROCEDURAL PAIN 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    SPINAL FRACTURE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    WOUND DEHISCENCE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ALCOHOL POISONING 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    JOINT DISLOCATION 4/539 (0.7%) 0/433 (0%) 0/219 (0%)
    FAILURE OF IMPLANT 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    TRAUMATIC FRACTURE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ACCIDENTAL OVERDOSE 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    LOWER LIMB FRACTURE 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    PROCEDURAL VOMITING 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    UPPER LIMB FRACTURE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    FEMORAL NECK FRACTURE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    VASCULAR PSEUDOANEURYSM 0/539 (0%) 2/433 (0.5%) 0/219 (0%)
    INCORRECT DOSE ADMINISTERED 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    MEDICAL DEVICE COMPLICATION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    POST PROCEDURAL COMPLICATION 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    DISLOCATION OF JOINT PROSTHESIS 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    Investigations
    ARTERIOGRAM 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    WEIGHT DECREASED 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    LABORATORY TEST ABNORMAL 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ELECTROCARDIOGRAM ST SEGMENT ABNORMAL 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    Metabolism and nutrition disorders
    OBESITY 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    DEHYDRATION 2/539 (0.4%) 2/433 (0.5%) 0/219 (0%)
    DIABETES MELLITUS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    DECREASED APPETITE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    Musculoskeletal and connective tissue disorders
    MYALGIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    BURSITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ARTHRITIS 7/539 (1.3%) 3/433 (0.7%) 1/219 (0.5%)
    BACK PAIN 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    BONE CYST 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    SYNOVITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ARTHRALGIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    MONARTHRITIS 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    METATARSALGIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    OSTEONECROSIS 3/539 (0.6%) 2/433 (0.5%) 0/219 (0%)
    SYNOVIAL CYST 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    FOOT DEFORMITY 3/539 (0.6%) 0/433 (0%) 1/219 (0.5%)
    OSTEOARTHRITIS 20/539 (3.7%) 2/433 (0.5%) 2/219 (0.9%)
    RHEUMATOID NODULE 0/539 (0%) 2/433 (0.5%) 0/219 (0%)
    SPONDYLOLISTHESIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    MUSCLE HAEMORRHAGE 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    RHEUMATOID ARTHRITIS 36/539 (6.7%) 13/433 (3%) 6/219 (2.7%)
    SOFT TISSUE NECROSIS 0/539 (0%) 0/433 (0%) 1/219 (0.5%)
    OSTEOPOROTIC FRACTURE 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    SPINAL COLUMN STENOSIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    SYSTEMIC LUPUS ERYTHEMATOSUS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    INTERVERTEBRAL DISC PROTRUSION 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    LYMPHOMA 1/539 (0.2%) 1/433 (0.2%) 0/219 (0%)
    NEOPLASM 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    LEIOMYOMA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    COLON CANCER 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    LUNG NEOPLASM 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    CARDIAC MYXOMA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PROSTATE CANCER 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    THYROID NEOPLASM 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    UTERINE LEIOMYOMA 3/539 (0.6%) 0/433 (0%) 0/219 (0%)
    ENDOMETRIAL CANCER 1/539 (0.2%) 0/433 (0%) 1/219 (0.5%)
    METASTATIC NEOPLASM 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    BASAL CELL CARCINOMA 8/539 (1.5%) 4/433 (0.9%) 1/219 (0.5%)
    BENIGN BREAST NEOPLASM 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    FIBROADENOMA OF BREAST 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    LUNG NEOPLASM MALIGNANT 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    SQUAMOUS CELL CARCINOMA 3/539 (0.6%) 1/433 (0.2%) 0/219 (0%)
    MYELODYSPLASTIC SYNDROME 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    NEUROENDOCRINE CARCINOMA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    GASTROINTESTINAL NEOPLASM 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    MALIGNANT MELANOMA IN SITU 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ACUTE LYMPHOCYTIC LEUKAEMIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    BRONCHIOLOALVEOLAR CARCINOMA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    LYMPHOPROLIFERATIVE DISORDER 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    METASTATIC MALIGNANT MELANOMA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    SQUAMOUS CELL CARCINOMA OF SKIN 4/539 (0.7%) 0/433 (0%) 1/219 (0.5%)
    EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    Nervous system disorders
    APHASIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    SYNCOPE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    MIGRAINE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    DIZZINESS 0/539 (0%) 0/433 (0%) 1/219 (0.5%)
    HYPOAESTHESIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    OPTIC NEURITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    POLYNEUROPATHY 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    TENSION HEADACHE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    NERVE COMPRESSION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    CEREBRAL INFARCTION 0/539 (0%) 0/433 (0%) 1/219 (0.5%)
    CERVICAL MYELOPATHY 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    LOSS OF CONSCIOUSNESS 0/539 (0%) 1/433 (0.2%) 1/219 (0.5%)
    CARPAL TUNNEL SYNDROME 0/539 (0%) 1/433 (0.2%) 1/219 (0.5%)
    CAROTID ARTERY STENOSIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    CEREBROVASCULAR ACCIDENT 4/539 (0.7%) 1/433 (0.2%) 0/219 (0%)
    TRANSIENT ISCHAEMIC ATTACK 2/539 (0.4%) 1/433 (0.2%) 0/219 (0%)
    COMPLEX REGIONAL PAIN SYNDROME 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    Psychiatric disorders
    DELIRIUM 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    DEPRESSION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    Renal and urinary disorders
    RENAL COLIC 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    RENAL FAILURE 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    NEPHROLITHIASIS 2/539 (0.4%) 1/433 (0.2%) 0/219 (0%)
    CALCULUS BLADDER 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    URINARY RETENTION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    RENAL FAILURE ACUTE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    URINARY INCONTINENCE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    RENAL FAILURE CHRONIC 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    Reproductive system and breast disorders
    CYSTOCELE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    RECTOCELE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    METRORRHAGIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    OVARIAN CYST 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    ENDOMETRIOSIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    UTERINE POLYP 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    UTERINE PROLAPSE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    BREAST CALCIFICATIONS 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    BENIGN PROSTATIC HYPERPLASIA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    Respiratory, thoracic and mediastinal disorders
    ASTHMA 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    HYPOXIA 0/539 (0%) 0/433 (0%) 1/219 (0.5%)
    DYSPNOEA 1/539 (0.2%) 0/433 (0%) 1/219 (0.5%)
    ATELECTASIS 0/539 (0%) 0/433 (0%) 1/219 (0.5%)
    HAEMOPTYSIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PNEUMONITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PNEUMOTHORAX 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PLEURAL EFFUSION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PULMONARY OEDEMA 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PULMONARY EMBOLISM 2/539 (0.4%) 0/433 (0%) 0/219 (0%)
    RESPIRATORY FAILURE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    SLEEP APNOEA SYNDROME 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    TONSILLAR INFLAMMATION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    INTERSTITIAL LUNG DISEASE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1/539 (0.2%) 1/433 (0.2%) 0/219 (0%)
    Skin and subcutaneous tissue disorders
    INGROWING NAIL 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    DERMATOMYOSITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    Vascular disorders
    HYPERTENSION 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    VARICOSE VEIN 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    AORTIC ANEURYSM 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    THROMBOPHLEBITIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ARTERIAL DISORDER 0/539 (0%) 0/433 (0%) 1/219 (0.5%)
    VENOUS THROMBOSIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    HYPOVOLAEMIC SHOCK 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    DEEP VEIN THROMBOSIS 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    PERIPHERAL ISCHAEMIA 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    AORTIC ANEURYSM RUPTURE 1/539 (0.2%) 0/433 (0%) 0/219 (0%)
    ARTERIAL THROMBOSIS LIMB 0/539 (0%) 1/433 (0.2%) 0/219 (0%)
    Other (Not Including Serious) Adverse Events
    ABA + MTX OL ABA + MTX DB MTX + Placebo DB
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 466/539 (86.5%) 320/433 (73.9%) 144/219 (65.8%)
    Blood and lymphatic system disorders
    ANAEMIA 35/539 (6.5%) 9/433 (2.1%) 8/219 (3.7%)
    Eye disorders
    CONJUNCTIVITIS 37/539 (6.9%) 4/433 (0.9%) 2/219 (0.9%)
    Gastrointestinal disorders
    NAUSEA 53/539 (9.8%) 53/433 (12.2%) 25/219 (11.4%)
    VOMITING 30/539 (5.6%) 17/433 (3.9%) 8/219 (3.7%)
    DIARRHOEA 83/539 (15.4%) 48/433 (11.1%) 22/219 (10%)
    DYSPEPSIA 72/539 (13.4%) 28/433 (6.5%) 10/219 (4.6%)
    GASTRITIS 29/539 (5.4%) 9/433 (2.1%) 6/219 (2.7%)
    ABDOMINAL PAIN 33/539 (6.1%) 12/433 (2.8%) 7/219 (3.2%)
    ABDOMINAL PAIN UPPER 50/539 (9.3%) 19/433 (4.4%) 13/219 (5.9%)
    General disorders
    FATIGUE 32/539 (5.9%) 24/433 (5.5%) 15/219 (6.8%)
    CHEST PAIN 38/539 (7.1%) 7/433 (1.6%) 5/219 (2.3%)
    OEDEMA PERIPHERAL 38/539 (7.1%) 13/433 (3%) 7/219 (3.2%)
    Infections and infestations
    RHINITIS 42/539 (7.8%) 15/433 (3.5%) 7/219 (3.2%)
    INFLUENZA 76/539 (14.1%) 30/433 (6.9%) 12/219 (5.5%)
    SINUSITIS 64/539 (11.9%) 19/433 (4.4%) 15/219 (6.8%)
    BRONCHITIS 95/539 (17.6%) 37/433 (8.5%) 16/219 (7.3%)
    PHARYNGITIS 70/539 (13%) 27/433 (6.2%) 10/219 (4.6%)
    GASTROENTERITIS 42/539 (7.8%) 10/433 (2.3%) 9/219 (4.1%)
    NASOPHARYNGITIS 137/539 (25.4%) 66/433 (15.2%) 25/219 (11.4%)
    URINARY TRACT INFECTION 118/539 (21.9%) 21/433 (4.8%) 11/219 (5%)
    UPPER RESPIRATORY TRACT INFECTION 131/539 (24.3%) 47/433 (10.9%) 21/219 (9.6%)
    Musculoskeletal and connective tissue disorders
    BACK PAIN 110/539 (20.4%) 40/433 (9.2%) 13/219 (5.9%)
    TENDONITIS 29/539 (5.4%) 1/433 (0.2%) 3/219 (1.4%)
    Nervous system disorders
    HEADACHE 99/539 (18.4%) 77/433 (17.8%) 26/219 (11.9%)
    DIZZINESS 54/539 (10%) 41/433 (9.5%) 16/219 (7.3%)
    Psychiatric disorders
    ANXIETY 27/539 (5%) 15/433 (3.5%) 6/219 (2.7%)
    INSOMNIA 51/539 (9.5%) 12/433 (2.8%) 6/219 (2.7%)
    DEPRESSION 41/539 (7.6%) 15/433 (3.5%) 7/219 (3.2%)
    Respiratory, thoracic and mediastinal disorders
    COUGH 83/539 (15.4%) 31/433 (7.2%) 15/219 (6.8%)
    RHINITIS ALLERGIC 29/539 (5.4%) 3/433 (0.7%) 4/219 (1.8%)
    OROPHARYNGEAL PAIN 31/539 (5.8%) 11/433 (2.5%) 7/219 (3.2%)
    Skin and subcutaneous tissue disorders
    RASH 30/539 (5.6%) 19/433 (4.4%) 1/219 (0.5%)
    Vascular disorders
    HYPERTENSION 86/539 (16%) 26/433 (6%) 4/219 (1.8%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

    Results Point of Contact

    Name/Title BMS Study Director
    Organization Bristol Myers-Squibb
    Phone
    Email clinical.trials@bms.com
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00048568
    Other Study ID Numbers:
    • IM101-102
    First Posted:
    Nov 13, 2002
    Last Update Posted:
    Dec 5, 2011
    Last Verified:
    Oct 1, 2011