Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00048581
• Collaborator: (none)
• Enrollment: 738
• Locations: 42
• Arms: 3
• Duration (Months): 81
• Patients Per Site: 17.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this clinical research study is to determine whether abatacept treatment on a background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF therapy in the last 3 months and did not respond. The safety of treatment with abatacept will also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months after the start of the study.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Abatacept; Drug: Placebo; Drug: Abatacept	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 738 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background Disease Modifying Anti-Rheumatic Drugs (DMARDS) Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy
• Study Start Date: Dec 1, 2002
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Abatacept Short Term Portion of Study	Drug: Abatacept; Vials, intravenous (IV), ~10mg/kg abatacept, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.; Other Names: Orencia BMS-188667 CTLA4Ig
Placebo Comparator: Placebo Short Term Portion of Study	Drug: Placebo; Vials, IV, 0mg, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
Active Comparator: Abatacept (Long Term) Long Term Portion of Study: All participants receive Active Drug	Drug: Abatacept; Vials, IV, ~10mg/kg abatacept, every 4 weeks, 5.5 years; Other Names: Orencia BMS-188667 CTLA4Ig

Outcome Measures

Primary Outcome Measures

1. Double-blind Period (DB); Number of Participants With American College of Rheumatology (ACR) 20 Response at Day 169 [Day 169]

   ACR 20 response requires a participant 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, participant global assessment of disease, participant 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. DB; Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) [Day 169]

   The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.

3. Open-Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation [From first day of OL to 5.5 years]

   AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment. SAE=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.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug

4. OL; Number of Participants AEs of Special Interest [From first day of OL to 5.5 years]

   AE=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 are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).

5. OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria [From first day of OL to 5.5 years]

   Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). 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/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<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. OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria [From first day of OL to 5.5 years]

   Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; 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; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL

7. OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL [Baseline and Days 169, 365, 729, and 1093]

   Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with serum samples available at that visit.

8. OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL [BL, Days 169, 365, 729, and 1093]

   Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with serum samples available at that visit.

Secondary Outcome Measures

1. DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time [Days 15, 29, 57, 85, 113, 141, and 169]

   ACR 20/50/70 response requires a participant to have a 20/50/70% reduction in the number of swollen and tender joints, and a reduction of 20/50/70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant 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 20/50/70 response if the participant had ACR 20/50/70 observed for at least 2 consecutive study visits.

2. DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component [BL]

   The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Time-matched baseline TJC values for each post-baseline TJC in the DB were presented for each visit and represent the mean baseline TJC value for only that cohort of participants with TJCs available at that visit.

3. DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component [BL, Days 15, 29, 57, 85, 113, 141, and 169]

   The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.

4. DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component [Days 15, 29, 57, 85, 113, 141, and 169]

   The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicates increasing level of severity. Time-matched baseline SJC values for each post-baseline SJC in the DB were presented for each visit and represent the mean baseline SJC value for only that cohort of participants with SJCs available at that visit.

5. DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component [Days 15, 29, 57, 85, 113, 141, and 169]

   The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicate increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.

6. DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component [BL]

   The participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Pain Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.

7. DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component [BL, Days 15, 29, 57, 85, 113, 141, and 169]

   Participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.

8. DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component [BL]

   HAQ-DI is a self-administered questionnaire composed of 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ-DI is the weighted sum of the scale scores, with higher scores indicating poorer function. For each post-BL visit, time-matched BL HAQ-DI values were presented and represent the mean BL value for only that cohort of participants with data available at that visit.

9. DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component [BL, Days 15, 29, 57, 85, 113, 141, and 169]

   A self-administered questionnaire with 20 questions assessing physical function in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Questions evaluated on a 4-point scale:0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=weighted sum of scale scores, with higher scores indicating poorer function. Mean time-matched % change from BL=(time-matched BL value - Post-BL value)/time-matched BL value x100, where time-matched BL value=the mean BL value for only that cohort of participants with data available at that visit.

10. DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component [BL]

    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 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.

11. DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component [BL, Days 15, 29, 57, 85, 113, 141, and 169]

    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. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.

12. DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component [BL]

    Physician global rheumatoid arthritis (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. For each post-baseline visit in the DB, time-matched baseline Physician Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.

13. DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component [BL, Days 15, 29, 57, 85, 113, 141, and 169]

    Physician global rheumatoid arthritis (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. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.

14. DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component [BL]

    CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels of CRP indicate increasing level of disease. For each post-baseline visit in the DB, time-matched baseline CRP values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.

15. DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component [Days 15, 29, 57, 85, 113, 141, and 169]

    CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.

16. DB; Mean Baseline Levels of Disease Biomarkers (Interleukin-6 (IL-6), Soluble IL-2 Receptor [sIL-2R], and Tumor Necrosing Factor [TNF]-Alpha) in Participants With Measurements at Day 169 [BL]

    Potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.

17. DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (IL-6, sIL-2R, and TNF-alpha) in Participants With Measurements at Day 169 [BL, Day 169]

    The mean change from baseline in levels of potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. Change from Baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.

18. DB; Mean Baseline Levels of Disease Biomarkers (E-Selectin, Soluble Inter-Cellular Adhesion Molecule 1 [sICAM-1], and Matrix Metalloproteinase-3 [MMP-3]) in Participants With Measurements at Day 169 [BL]

    Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.

19. DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (E-Selectin, sICAM-1, and MMP-3) in Participants With Measurements at Day 169 [BL, Day 169]

    Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. Change from Baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.

20. DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status [BL, Day 169]

    Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. A positive value for RF was >20 IU/mL; a negative value for RF was ≤ 20 IU/mL.

21. DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85 [BL]

    SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Mean BL value presented represents a time-matched Day 85 BL value for only that cohort of participants with data available at that visit.

22. DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores [BL, Day 85]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from Baseline= Post-baseline value - time-matched baseline value, where time-matched BL value = the mean BL value for only that cohort of participants with data available at Day 85.

23. DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 [BL]

    SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with data available at that visit.

24. DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 [BL, Day 169]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from Baseline= Post-baseline value - time-matched baseline value, where time-matched BL value = the mean BL value for only that cohort of participants with data available at Day 169.

25. DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 [BL]

    The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI is a weighted sum of the scale scores, with a higher score indicating poorer function. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.

26. DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 [BL, Day 169]

    HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.

27. DB; Mean Disease Activity Score (DAS)28 (C-Reactive Protein [CRP]) and Mean Disease Activity Score (Erythrocyte Sedimentation Rate [ESR]) at Day 169 [BL, Day 169]

    The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline. The mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with assessments available at that visit.

28. DB; Adjusted Mean Change From Baseline to Day 169 in DAS28 (CRP) and DAS28 (ESR) [BL, Day 169]

    The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.

29. DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation [From BL up to database lock for DB period (6/2/2004)]

    AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment. SAE=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.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug

30. DB; Number of Participants AEs of Special Interest [From BL up to database lock for DB period (6/2/2004)]

    AE=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 are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).

31. DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria [From BL up to database lock for DB period (6/2/2004)]

    Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). 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/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<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.

32. DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria [From BL up to database lock for DB period (6/2/2004)]

    Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; 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; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL

33. DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA) [From BL to Day 169]

    Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.

34. OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL [Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821]

    ACR 20/50/70 response requires a participant to have a 20/50/70% reduction in the number of swollen and tender joints, and a reduction of 20/50/70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant 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 20/50/70 response if the participant had ACR 20/50/70 observed for at least 2 consecutive study visits.

35. OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL [Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821]

    The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.

36. OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL [BL]

    The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

37. OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL [BL, Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821]

    DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.

38. OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL [BL]

    The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

39. OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL [BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821]

    DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.

40. OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL [Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821]

    The HAQ disability index (HAQ DI) is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

41. OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL [BL]

    The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI is a weighted sum of the scale scores, with a higher score indicating poorer function. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

42. OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL [BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821]

    HAQ-DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit

43. OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL [BL]

    RF is an autoantibody most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. Time-matched baseline levels of RF were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

44. OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821]

    RF is an autoantibody most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

45. OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL [BL]

    CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Time-matched baseline levels of CRP were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

46. OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821]

    CRP is an acute phase reactant protein that is a clinical marker for RA. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

47. OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL [BL]

    ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Time-matched baseline levels of ESR were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

48. OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821]

    ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

49. OL; Mean Time-matched Baseline Levels of Soluble Interleukin 2 Receptor (sIL-2R) Over Time For Participants Treated in the OL [BL]

    IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Time-matched baseline levels of IL-2R were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit

50. OL; Mean Time-matched Change From Baseline in Levels of sIL-2R Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821]

    IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

51. OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL [BL]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

52. OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL [BL, Days 169, 365, 729, 1093, 1457, and 1821]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

53. OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL [BL]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

54. OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1457, and 1821]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

55. OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL [BL]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

56. OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1457, and 1821]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

57. OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL [BL]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

58. OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1457, and 1821]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

59. OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL [BL]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

60. OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1457, and 1821]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

61. OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL [BL]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

62. OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1457, and 1821]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

63. OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL [BL]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

64. OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1457, and 1821]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

65. OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL [BL]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

66. OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1457, and 1821]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

67. OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL [BL]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

68. OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1457, and 1821]

    SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

69. OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL [BL]

    The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem 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 a higher score reflecting more severe problems with sleep. The mean score of the SPI in a population with chronic problems is 29.

70. OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1457, and 1821]

    The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem 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 a higher score reflecting more severe problems with sleep. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

71. OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL [BL]

    Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

72. OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL [BL, Days 169, 365, 729, 1093, 1457, and 1821]

    Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

73. OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL [BL]

    Limitations on activities of daily living in the OL period at each study visit were measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.

74. OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL [Days 169, 365, 729, 1093, 1457, and 1821]

    Limitations on activities of daily living in the OL period at each study visit was measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.

75. Cumulative Analysis (DB + OL); Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbent Assay (ELISA) [From BL (Day 1) to Day 1821]

    Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.

Eligibility Criteria

Criteria

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

Eligibility Criteria:

• Active rheumatoid arthritis currently failing anti-TNF therapy or have failed anti-TNF therapy in the past.

Exclusion Criteria:

• Women who are pregnant or breast feeding

• Current symptoms of serious medical disease

• History of cancer in last 5 years other than non-melanoma skin cancer

• Chronic serious infection

• Active TB requiring treatment in last 5 years

• Herpes zoster in last 2 months

• Any active viral infection including Human Immunodeficiency Virus (HIV)

• Serious side effects associated with previous anti-TNF therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Birmingham	Alabama	United States
2	Local Institution	Mobile	Alabama	United States
3	Local Institution	Paradise Valley	Arizona	United States
4	Local Institution	La Jolla	California	United States
5	Local Institution	Long Beach	California	United States
6	Local Institution	Palo Alto	California	United States
7	Local Institution	Rancho Mirage	California	United States
8	Local Institution	Denver	Colorado	United States
9	Local Institution	Englewood	Colorado	United States
10	Local Institution	Bridgeport	Connecticut	United States
11	Local Institution	Hamden	Connecticut	United States
12	Local Institution	Clearwater	Florida	United States
13	Local Institution	Fort Lauderdale	Florida	United States
14	Local Institution	Largo	Florida	United States
15	Local Institution	Palm Harbor	Florida	United States
16	Local Institution	Tampa	Florida	United States
17	Local Institution	Rome	Georgia	United States
18	Local Institution	Indianapolis	Indiana	United States
19	Local Institution	Wichita	Kansas	United States
20	Local Institution	New Orleans	Louisiana	United States
21	Local Institution	Boston	Massachusetts	United States
22	Local Institution	Springfield	Massachusetts	United States
23	Local Institution	Lincoln	Nebraska	United States
24	Local Institution	New Brunswick	New Jersey	United States
25	Local Institution	Albany	New York	United States
26	Local Institution	Syracuse	New York	United States
27	Local Institution	Charlotte	North Carolina	United States
28	Local Institution	Hickory	North Carolina	United States
29	Local Institution	Bismarck	North Dakota	United States
30	Local Institution	Cincinnati	Ohio	United States
31	Local Institution	Oklahoma City	Oklahoma	United States
32	Local Institution	Eugene	Oregon	United States
33	Local Institution	Portland	Oregon	United States
34	Local Institution	Duncansville	Pennsylvania	United States
35	Local Institution	Norristown	Pennsylvania	United States
36	Local Institution	Sellersville	Pennsylvania	United States
37	Local Institution	Willow Grove	Pennsylvania	United States
38	Local Institution	Charleston	South Carolina	United States
39	Local Institution	Austin	Texas	United States
40	Local Institution	Dallas	Texas	United States
41	Local Institution	Vancouver	Washington	United States
42	Local Institution	Milwaukee	Wisconsin	United States

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hassett AL, Li T, Buyske S, Savage SV, Gignac MA. The multi-faceted assessment of independence in patients with rheumatoid arthritis: preliminary validation from the ATTAIN study. Curr Med Res Opin. 2008 May;24(5):1443-53. doi: 10.1185/030079908X297376 . Epub 2008 Apr 9.
• Spritzer KL, Hays RD. (2003, November). MOS Sleep Scale: A Manual For Use and Scoring, Version 1.0. Los Angeles, CA.
• Stewart AL and Ware JE. Measuring function and well being. The Medical Outcomes Study Approach. Durham, NC: Duke University Press. 1992.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT00048581
• Other Study ID Numbers: IM101-029
• First Posted: Nov 13, 2002
• Last Update Posted: Nov 21, 2011
• Last Verified: Nov 1, 2011

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Abatacept

Study Results

Participant Flow

Pre-assignment Detail	738 participants were enrolled and 393 participants were randomized. Two participants were randomized in error and were not treated.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)	Open-label ABA
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.	All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
Period Title: Double-Blind Period
STARTED	258	133	0
COMPLETED	223	99	0
NOT COMPLETED	35	34	0
Period Title: Double-Blind Period
STARTED	0	0	317
COMPLETED	0	0	150
NOT COMPLETED	0	0	167

Baseline Characteristics

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)	Total
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.	Total of all reporting groups
Overall Participants	258	133	391
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.4 (12.4)	52.7 (11.3)	53.2 (12.1)
Sex: Female, Male (Count of Participants)
Female	199 77.1%	106 79.7%	305 78%
Male	59 22.9%	27 20.3%	86 22%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.4%	1 0.8%	2 0.5%
Asian	0 0%	2 1.5%	2 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	9 3.5%	5 3.8%	14 3.6%
White	248 96.1%	124 93.2%	372 95.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 0.8%	1 0.3%
Region of Enrollment (participants) [Number]
North America	189 73.3%	99 74.4%	288 73.7%
Europe	69 26.7%	34 25.6%	103 26.3%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	78.2 (19.0)	78.2 (21.0)	78.2 (19.7)

Outcome Measures

1. Primary Outcome

Title	Double-blind Period (DB); Number of Participants With American College of Rheumatology (ACR) 20 Response at Day 169
Description	ACR 20 response requires a participant 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, participant global assessment of disease, participant 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

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized participants who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Number [participants]	129 50%	26 19.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	The first coprimary endpoint efficacy analysis tested for differences in ACR 20 response rate (RR) between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving placebo plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The a priori threshold for statistical significance was 5%. ACR 20 RR at 6 mos for PLA was expected to be ~25%. A sample of 256 in the ABA arm and 128 in PLA arm will yield a 96% power to detect a difference of 20% in ACR 20 at 5% significance level.
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)
Method of Estimation	Estimation Parameter	Est. Weighted. Diff: Day 169 ACR 20
	Estimated Value	30.8
	Confidence Interval	(2-Sided) 95%; 20.6 to 41.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.

2. Primary Outcome

Title	DB; Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ)
Description	The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
Time Frame	Day 169

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Number [participants]	121 46.9%	31 23.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	The two primary efficacy analyses tested first for differences in ACR 20 followed by testing HAQ response rates between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	If the ACR20 analysis was not significant (5% level), then the comparison for HAQ response was not undertaken. If ACR20 comparison was significant (5% level), then CMH Chi-square test compared HAQ response between groups (5% level).
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)
Method of Estimation	Estimation Parameter	Est. of Weighted Diff: Day 169 HAQ
	Estimated Value	24.0
	Confidence Interval	(2-Sided) 95%; 13.8 to 34.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	All comparisons of changes from baseline and construction of confidence intervals for continuous measures were based on an ANCOVA model with treatment as the main factor and baseline value as covariate.

3. Secondary Outcome

Title	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time
Description	ACR 20/50/70 response requires a participant to have a 20/50/70% reduction in the number of swollen and tender joints, and a reduction of 20/50/70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant 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 20/50/70 response if the participant had ACR 20/50/70 observed for at least 2 consecutive study visits.
Time Frame	Days 15, 29, 57, 85, 113, 141, and 169

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 ACR 20	45 17.4%	7 5.3%
Day 15 ACR 50	6 2.3%	0 0%
Day 15 ACR 70	2 0.8%	0 0%
Day 29 ACR 20	84 32.6%	25 18.8%
Day 29 ACR 50	22 8.5%	4 3%
Day 29 ACR 70	6 2.3%	1 0.8%
Day 57 ACR 20	118 45.7%	32 24.1%
Day 57 ACR 50	34 13.2%	9 6.8%
Day 57 ACR 70	13 5%	0 0%
Day 85 ACR 20	118 45.7%	24 18%
Day 85 ACR 50	46 17.8%	8 6%
Day 85 ACR 70	15 5.8%	1 0.8%
Day 113 ACR 20	126 48.8%	31 23.3%
Day 113 ACR 50	46 17.8%	5 3.8%
Day 113 ACR 70	20 7.8%	0 0%
Day 141 ACR 20	141 54.7%	26 19.5%
Day 141 ACR 50	65 25.2%	6 4.5%
Day 141 ACR 70	26 10.1%	0 0%
Day 169 ACR 20	129 50%	26 19.5%
Day 169 ACR 50	52 20.2%	5 3.8%
Day 169 ACR 70	26 10.1%	2 1.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 15 ACR 20
	Estimated Value	12.3
	Confidence Interval	(2-Sided) 95%; 4.6 to 20.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 15 ACR 50
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; -0.8 to 5.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.784
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 15 ACR 70
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -1.3 to 2.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 29 ACR 20
	Estimated Value	14.0
	Confidence Interval	(2-Sided) 95%; 4.0 to 24.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 29 ACR 50
	Estimated Value	5.6
	Confidence Interval	(2-Sided) 95%; -0.2 to 11.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.473
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 29 ACR 70
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95%; -1.8 to 4.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 57 ACR 20
	Estimated Value	22.0
	Confidence Interval	(2-Sided) 95%; 11.3 to 32.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.076
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 57 ACR 50
	Estimated Value	6.5
	Confidence Interval	(2-Sided) 95%; -0.6 to 13.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 57 ACR 70
	Estimated Value	5.1
	Confidence Interval	(2-Sided) 95%; 0.7 to 9.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 85 ACR 20
	Estimated Value	28.0
	Confidence Interval	(2-Sided) 95%; 17.4 to 38.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 85 ACR 50
	Estimated Value	12.0
	Confidence Interval	(2-Sided) 95%; 4.1 to 19.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.033
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 85 ACR 70
	Estimated Value	5.1
	Confidence Interval	(2-Sided) 95%; 0.4 to 9.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 113 ACR 20
	Estimated Value	25.9
	Confidence Interval	(2-Sided) 95%; 15.1 to 36.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 113 ACR 50
	Estimated Value	14.2
	Confidence Interval	(2-Sided) 95%; 6.6 to 21.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 113 ACR 70
	Estimated Value	7.8
	Confidence Interval	(2-Sided) 95%; 2.6 to 13.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 141 ACR 20
	Estimated Value	35.5
	Confidence Interval	(2-Sided) 95%; 24.6 to 46.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 141 ACR 50
	Estimated Value	20.9
	Confidence Interval	(2-Sided) 95%; 12.2 to 29.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 141 ACR 70
	Estimated Value	10.2
	Confidence Interval	(2-Sided) 95%; 4.4 to 16.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 169 ACR 20
	Estimated Value	30.8
	Confidence Interval	(2-Sided) 95%; 20.0 to 41.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 169 ACR 50
	Estimated Value	16.6
	Confidence Interval	(2-Sided) 95%; 8.6 to 24.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Weighted Diff)
Method of Estimation	Estimation Parameter	Est. of Diff: Day 169 ACR 70
	Estimated Value	8.7
	Confidence Interval	(2-Sided) 95%; 2.7 to 14.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.

4. Secondary Outcome

Title	DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component
Description	The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Time-matched baseline TJC values for each post-baseline TJC in the DB were presented for each visit and represent the mean baseline TJC value for only that cohort of participants with TJCs available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with TJCs. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=251, n=126): baseline	31.33 (12.86)	32.75 (13.13)
Day 15 cohort (n=251, n=126): post-baseline	25.58 (14.39)	30.35 (15.37)
Day 29 cohort (n=248, n=128): baseline	31.41 (13.11)	32.72 (13.06)
Day 29 cohort (n=248, n=128): post-baseline	21.61 (14.53)	27.52 (15.85)
Day 57 cohort (n=251, n=129): baseline	31.17 (12.90)	32.31 (13.14)
Day 57 cohort (n=251, n=129): post-baseline	18.88 (14.41)	24.20 (16.46)
Day 85 cohort (n=249, n=129): baseline	31.42 (13.05)	32.58 (13.10)
Day 85 cohort (n=249, n=129): post-baseline	18.51 (14.15)	25.56 (15.80)
Day 113 cohort (n=246, n=128): baseline	31.32 (13.10)	32.65 (13.15)
Day 113 cohort (n=246, n=128): post-baseline	16.76 (14.18)	25.21 (16.18)
Day 141 cohort (n=252, n=128): baseline	31.34 (13.10)	32.28 (13.21)
Day 141 cohort (n=252, n=128): post-baseline	16.04 (13.89)	23.67 (15.62)
Day 169 cohort (n=254, n=130): baseline	31.33 (13.06)	32.43 (13.16)
Day 169 cohort (n=254, n=130): post-baseline	16.21 (13.94)	25.55 (16.30)

5. Secondary Outcome

Title	DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component
Description	The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.
Time Frame	BL, Days 15, 29, 57, 85, 113, 141, and 169

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with TJCs. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=251, n=126)	19.74 (2.19)	6.43 (3.25)
Day 29 cohort (n=248, n=128)	32.68 (2.41)	14.96 (3.84)
Day 57 cohort (n=251, n=129)	40.52 (2.56)	24.99 (3.62)
Day 85 cohort (n=249, n=129)	40.40 (2.62)	20.94 (3.49)
Day 113 cohort (n=246, n=128)	46.20 (2.76)	21.72 (3.87)
Day 141 cohort (n=252, n=128)	49.06 (2.53)	24.03 (4.05)
Day 169 cohort (n=254, n=130)	47.76 (2.66)	20.04 (3.84)

6. Secondary Outcome

Title	DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component
Description	The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicates increasing level of severity. Time-matched baseline SJC values for each post-baseline SJC in the DB were presented for each visit and represent the mean baseline SJC value for only that cohort of participants with SJCs available at that visit.
Time Frame	Days 15, 29, 57, 85, 113, 141, and 169

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with SJCs. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=251, n=126): baseline	22.31 (10.08)	22.00 (9.79)
Day 15 cohort (n=251, n=126): post-line	17.88 (10.42)	19.06 (10.97)
Day 29 cohort (n=248, n=128): baseline	22.49 (10.32)	21.86 (9.79)
Day 29 cohort (n=248, n=128): post-baseline	15.55 (10.62)	17.95 (11.83)
Day 57 cohort (n=251, n=129): baseline	22.15 (10.05)	21.80 (9.78)
Day 57 cohort (n=251, n=129): post-baseline	13.44 (9.81)	15.98 (10.17)
Day 85 cohort (n=249, n=129): baseline	22.42 (10.30)	21.81 (9.77)
Day 85 cohort (n=249, n=129): post-baseline	12.44 (9.41)	16.25 (11.92)
Day 113 cohort (n=246, n=128): baseline	22.48 (10.34)	21.82 (9.81)
Day 113 cohort (n=246, n=128): post-baseline	12.18 (10.18)	16.28 (10.78)
Day 141 cohort (n=252, n=128): baseline	22.38 (10.29)	21.63 (9.74)
Day 141 cohort (n=252, n=128): post-baseline	11.06 (8.91)	15.92 (10.49)
Day 169 cohort (n=254, n=130): baseline	22.35 (10.25)	21.77 (9.75)
Day 169 cohort (n=254, n=130): post-baseline	12.00 (9.78)	16.18 (11.10)

7. Secondary Outcome

Title	DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component
Description	The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicate increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.
Time Frame	Days 15, 29, 57, 85, 113, 141, and 169

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with SJCs. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=251, n=126)	18.64 (2.38)	13.13 (3.03)
Day 29 cohort (n=248, n=128)	32.68 (2.41)	14.96 (3.84)
Day 57 cohort (n=251, n=129)	38.49 (2.70)	24.98 (3.45)
Day 85 cohort (n=249, n=129)	44.42 (2.30)	26.22 (3.72)
Day 113 cohort (n=246, n=128)	45.31 (2.75)	22.87 (3.72)
Day 141 cohort (n=252, n=128)	49.38 (2.42)	24.33 (3.77)
Day 169 cohort (n=254, n=130)	44.26 (2.84)	23.78 (3.87)

8. Secondary Outcome

Title	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component
Description	The participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Pain Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=247, n=126): baseline	71.09 (19.57)	69.20 (19.02)
Day 15 cohort (n=247, n=126): post-baseline	61.05 (22.45)	67.65 (20.48)
Day 29 cohort (n=240, n=128): baseline	70.45 (19.77)	69.80 (18.76)
Day 29 cohort (n=240, n=128): post-baseline	52.88 (23.93)	61.07 (24.13)
Day 57 cohort (n=246, n=129): baseline	70.72 (19.70)	69.26 (18.79)
Day 57 cohort (n=246, n=129): post-baseline	46.19 (25.26)	55.91 (25.85)
Day 85 cohort (n=245, n=129): baseline	70.87 (19.85)	69.40 (18.92)
Day 85 cohort (n=245, n=129): post-baseline	44.69 (26.13)	60.16 (25.05)
Day 113 cohort (n=239, n=126): baseline	70.93 (19.71)	70.27 (18.54)
Day 113 cohort (n=239, n=126): post-baseline	44.60 (26.19)	60.17 (25.53)
Day 141 cohort (n=249, n=127): baseline	70.85 (19.73)	69.34 (19.02)
Day 141 cohort (n=249, n=127): post-baseline	43.67 (27.20)	59.80 (25.08)
Day 169 cohort (n=251, n=130): baseline	70.89 (19.67)	69.47 (18.86)
Day 169 cohort (n=251, n=130): post-baseline	43.48 (27.76)	62.21 (24.73)

9. Secondary Outcome

Title	DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component
Description	Participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.
Time Frame	BL, Days 15, 29, 57, 85, 113, 141, and 169

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=247, n=126)	8.48 (3.82)	-3.19 (3.24)
Day 29 cohort (n=240, n=128)	18.31 (3.51)	8.36 (3.26)
Day 57 cohort (n=246, n=129)	24.58 (6.39)	16.65 (3.28)
Day 85 cohort (n=245, n=129)	26.76 (6.61)	8.59 (3.79)
Day 113 cohort (n=239, n=126)	28.46 (4.79)	9.87 (3.98)
Day 141 cohort (n=249, n=127)	27.29 (6.72)	4.32 (5.55)
Day 169 cohort (n=251, n=130)	28.64 (5.70)	4.36 (4.01)

10. Secondary Outcome

Title	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component
Description	HAQ-DI is a self-administered questionnaire composed of 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ-DI is the weighted sum of the scale scores, with higher scores indicating poorer function. For each post-BL visit, time-matched BL HAQ-DI values were presented and represent the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=244, n=124): baseline	1.84 (0.56)	1.86 (0.56)
Day 15 cohort (n=244, n=124): post-baseline	1.69 (0.60)	1.83 (0.56)
Day 29 cohort (n=239, n=127): baseline	1.84 (0.57)	1.85 (0.56)
Day 29 cohort (n=239, n=127): post-baseline	1.59 (0.64)	1.70 (0.62)
Day 57 cohort (n=245, n=127): baseline	1.83 (0.57)	1.84 (0.55)
Day 57 cohort (n=245, n=127): post-baseline	1.49 (0.65)	1.65 (0.63)
Day 85 cohort (n=242, n=126): baseline	1.84 (0.57)	1.86 (0.56)
Day 85 cohort (n=242, n=126): post-baseline	1.45 (0.64)	1.70 (0.63)
Day 113 cohort (n=238, n=126): baseline	1.85 (0.57)	1.85 (0.56)
Day 113 cohort (n=238, n=126): post-baseline	1.44 (0.70)	1.71 (0.64)
Day 141 cohort (n=247, n=126): baseline	1.84 (0.57)	1.86 (0.56)
Day 141 cohort (n=247, n=126): post-baseline	1.41 (0.71)	1.72 (0.64)
Day 169 cohort (n=248, n=128): baseline	1.84 (0.57)	1.85 (0.56)
Day 169 cohort (n=248, n=128): post-baseline	1.38 (0.72)	1.74 (0.63)

11. Secondary Outcome

Title	DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component
Description	A self-administered questionnaire with 20 questions assessing physical function in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Questions evaluated on a 4-point scale:0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=weighted sum of scale scores, with higher scores indicating poorer function. Mean time-matched % change from BL=(time-matched BL value - Post-BL value)/time-matched BL value x100, where time-matched BL value=the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 15, 29, 57, 85, 113, 141, and 169

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=244, n=124)	7.94 (1.45)	-1.10 (2.99)
Day 29 cohort (n=239, n=127)	13.75 (1.81)	6.79 (2.49)
Day 57 cohort (n=245, n=127)	19.05 (1.78)	9.61 (2.85)
Day 85 cohort (n=242, n=126)	21.00 (1.79)	7.10 (2.68)
Day 113 cohort (n=238, n=126)	22.77 (1.98)	5.96 (3.15)
Day 141 cohort (n=247, n=126)	24.41 (2.16)	6.50 (2.68)
Day 169 cohort (n=248, n=128)	25.48 (2.14)	5.08 (2.84)

12. Secondary Outcome

Title	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component
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 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=247, n=126): baseline	69.30 (19.70)	68.93 (20.38)
Day 15 cohort (n=247, n=126): post-baseline	58.55 (23.50)	65.15 (21.38)
Day 29 cohort (n=240, n=128): baseline	68.86 (19.88)	69.33 (20.03)
Day 29 cohort (n=240, n=128): post-baseline	52.48 (22.56)	61.13 (24.42)
Day 57 cohort (n=246, n=129): baseline	69.02 (19.84)	68.97 (20.10)
Day 57 cohort (n=246, n=129): post-baseline	45.07 (24.16)	56.60 (26.03)
Day 85 cohort (n=245, n=129): baseline	69.40 (19.72)	69.12 (20.23)
Day 85 cohort (n=245, n=129): post-baseline	43.27 (25.65)	60.18 (24.88)
Day 113 cohort (n=239, n=126): baseline	69.40 (19.68)	70.37 (19.15)
Day 113 cohort (n=239, n=126): post-baseline	45.05 (25.36)	58.46 (25.61)
Day 141 cohort (n=249, n=127): baseline	69.09 (19.83)	69.15 (20.36)
Day 141 cohort (n=249, n=127): post-baseline	43.72 (26.65)	59.24 (25.69)
Day 169 cohort (n=251, n=130): baseline	69.22 (19.80)	69.18 (20.16)
Day 169 cohort (n=251, n=130): post-baseline	43.51 (27.19)	60.35 (25.69)

13. Secondary Outcome

Title	DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component
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. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.
Time Frame	BL, Days 15, 29, 57, 85, 113, 141, and 169

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=247, n=126)	11.54 (2.88)	-3.18 (4.48)
Day 29 cohort (n=240, n=128)	18.31 (2.93)	2.13 (5.10)
Day 57 cohort (n=246, n=129)	29.84 (3.19)	10.94 (4.70)
Day 85 cohort (n=245, n=129)	32.03 (4.08)	2.89 (5.42)
Day 113 cohort (n=239, n=126)	30.83 (3.02)	8.01 (5.48)
Day 141cohort (n=249, n=127)	29.46 (4.72)	4.85 (5.51)
Day 169 cohort (n=251, n=130)	30.87 (4.10)	4.52 (5.40)

14. Secondary Outcome

Title	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component
Description	Physician global rheumatoid arthritis (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. For each post-baseline visit in the DB, time-matched baseline Physician Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=250, n=126): baseline	68.86 (17.40)	66.91 (16.78)
Day 15 cohort (n=250, n=126): post-baseline	54.07 (21.93)	61.43 (19.03)
Day 29 cohort (n=246, n=126): baseline	68.73 (17.41)	66.81 (16.91)
Day 29 cohort (n=246, n=126): post-baseline	44.96 (21.03)	53.71 (23.08)
Day 57 cohort (n=252, n=127): baseline	68.74 (17.34)	66.92 (16.64)
Day 57 cohort (n=252, n=127): post-baseline	41.46 (21.93)	49.21 (25.03)
Day 85 cohort (n=247, n=124):baseline	69.08 (17.42)	66.81 (16.82)
Day 85 cohort (n=247, n=124): post-baseline	37.54 (21.29)	53.06 (25.63)
Day 113 cohort (n=246, n=127): baseline	68.88 (17.26)	67.45 (16.66)
Day 113 cohort (n=246, n=127): post-baseline	37.15 (21.88)	54.49 (24.30)
Day 141 cohort (n=252, n=127): baseline	68.82 (17.39)	67.03 (16.96)
Day 141 cohort (n=252, n=127): post-baseline	34.32 (21.56)	51.58 (24.44)
Day 169 cohort (n=254, n=129): baseline	68.91 (17.40)	67.05 (16.84)
Day 169 cohort (n=254, n=129): post-baseline	36.46 (23.65)	52.37 (25.10)

15. Secondary Outcome

Title	DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component
Description	Physician global rheumatoid arthritis (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. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.
Time Frame	BL, Days 15, 29, 57, 85, 113, 141, and 169

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=250, n=126)	19.27 (2.45)	6.26 (2.47)
Day 29 cohort (n=246, n=126)	32.32 (2.59)	18.00 (3.08)
Day 57 cohort (n=252, n=127)	38.41 (2.38)	25.51 (3.28)
Day 85 cohort (n=247, n=124)	43.74 (2.20)	18.05 (4.04)
Day 113cohort (n=246, n=127)	45.11 (2.02)	17.53 (3.26)
Day 141 cohort (n=252, n=127)	49.35 (1.89)	21.34 (3.35)
Day 169 cohort (n=254, n=129)	45.18 (2.33)	21.28 (3.14)

16. Secondary Outcome

Title	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component
Description	CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels of CRP indicate increasing level of disease. For each post-baseline visit in the DB, time-matched baseline CRP values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=246, n=127): baseline	4.53 (3.92)	3.97 (3.57)
Day 15 cohort (n=246, n=127): post-baseline	3.20 (3.36)	4.01 (3.54)
Day 29 cohort (n=245, n=128): baseline	4.62 (4.03)	4.03 (3.62)
Day 29 cohort (n=245, n=128): post-baseline	2.70 (2.70)	4.02 (3.63)
Day 57 cohort (n=250, n=129): baseline	4.60 (3.99)	3.93 (3.58)
Day 57 cohort (n=250, n=129): post-baseline	2.39 (2.47)	3.73 (4.06)
Day 85 cohort (n=249, n=129): baseline	4.59 (3.95)	4.00 (3.61)
Day 85 cohort (n=249, n=129): post-baseline	2.36 (3.09)	4.13 (4.11)
Day 113 cohort (n=243, n=127): baseline	4.62 (4.00)	4.06 (3.62)
Day 113 cohort (n=243, n=127): post-baseline	2.26 (3.05)	4.31 (4.62)
Day 141 cohort (n=251, n=129): baseline	4.62 (3.98)	4.03 (3.60)
Day 141 cohort (n=251, n=129): post-baseline	2.20 (3.01)	3.83 (4.17)
Day 169 cohort (n=254, n=131): baseline	4.60 (3.97)	3.99 (3.59)
Day 169 cohort (n=254, n=131): post-baseline	2.31 (3.47)	3.97 (4.19)

17. Secondary Outcome

Title	DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component
Description	CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	Days 15, 29, 57, 85, 113, 141, and 169

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Day 15 cohort (n=246, n=127)	14.03 (6.70)	-20.8 (8.24)
Day 29 cohort (n=245, n=128)	24.05 (4.20)	-20.1 (6.81)
Day 57 cohort (n=250, n=129)	22.83 (8.55)	-14.8 (8.23)
Day 85 cohort (n=249, n=129)	25.87 (9.68)	-31.9 (9.82)
Day 113 cohort (n=243, n=127)	34.52 (4.33)	-32.1 (10.37)
Day 141 cohort (n=251, n=129)	33.47 (4.76)	-22.8 (9.78)
Day 169 cohort (n=254, n=131)	25.05 (8.44)	-28.4 (11.82)

18. Secondary Outcome

Title	DB; Mean Baseline Levels of Disease Biomarkers (Interleukin-6 (IL-6), Soluble IL-2 Receptor [sIL-2R], and Tumor Necrosing Factor [TNF]-Alpha) in Participants With Measurements at Day 169
Description	Potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
IL-6 (n=194, n=103)	46.19 (62.49)	43.18 (62.90)
sIL-2R (n=193, n=88)	1840 (767.0)	1879 (1001)
TNF-alpha (n=250, n=129)	35.24 (73.17)	30.64 (54.08)

19. Secondary Outcome

Title	DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (IL-6, sIL-2R, and TNF-alpha) in Participants With Measurements at Day 169
Description	The mean change from baseline in levels of potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. Change from Baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.
Time Frame	BL, Day 169

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
IL-6 (n=194, n=103)	-24.4 (4.54)	4.71 (8.13)
sIL-2R (n=193, n=88)	-565 (40.40)	-36.1 (77.37)
TNF-alpha (n=250, n=129)	-13.5 (4.06)	5.87 (8.27)

20. Secondary Outcome

Title	DB; Mean Baseline Levels of Disease Biomarkers (E-Selectin, Soluble Inter-Cellular Adhesion Molecule 1 [sICAM-1], and Matrix Metalloproteinase-3 [MMP-3]) in Participants With Measurements at Day 169
Description	Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
E-selectin (n=190, n=103)	93.03 (101.2)	84.53 (71.64)
sICAM-1 (n=187, n=103)	426.6 (218.6)	443.5 (327.1)
MMP3 (n=192, n=133)	86.53 (97.59)	84.18 (133.5)

21. Secondary Outcome

Title	DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (E-Selectin, sICAM-1, and MMP-3) in Participants With Measurements at Day 169
Description	Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. Change from Baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.
Time Frame	BL, Day 169

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
E-selectin (n=190, n=103)	-10.6 (4.97)	6.54 (4.34)
sICAM-1 (n=187, n=103)	-22.2 (16.58)	-29.5 (20.17)
MMP3 (n=192, n=133)	-37.0 (6.42)	-9.62 (11.51)

22. Secondary Outcome

Title	DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status
Description	Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. A positive value for RF was >20 IU/mL; a negative value for RF was ≤ 20 IU/mL.
Time Frame	BL, Day 169

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Baseline RF negative	46 17.8%	25 18.8%
Baseline RF negative change to RF positive	3 1.2%	3 2.3%
Baseline RF positive	154 59.7%	73 54.9%
Baseline RF positive change to RF negative	13 5%	0 0%

23. Secondary Outcome

Title	DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85
Description	SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Mean BL value presented represents a time-matched Day 85 BL value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
PCS (n=243, n=128)	27.41 (6.94)	27.77 (6.31)
MCS (n=243, n=128)	41.13 (12.35)	43.00 (11.94)
Physical Function Scale Component (n=246, n=129)	25.94 (8.90)	26.31 (8.36)
Role-Physical Scale Component (n=249, n=129)	30.50 (6.25)	31.96 (6.84)
Bodily Pain Scale Component (n=248, n=129)	30.49 (6.72)	31.28 (6.64)
General Health Scale Component (n=250, n=129)	34.75 (9.18)	34.95 (8.46)
Vitality Scale Component (n=249, n=129)	34.99 (8.51)	36.70 (9.10)
Social Functioning Scale Component (n=250, n=129)	33.06 (10.78)	33.95 (11.49)
Role-Emotional Scale Component (n=249, n=128)	35.79 (13.76)	37.07 (13.83)
Mental Health Scale Component (n=249, n=129)	40.35 (12.75)	42.72 (11.15)

24. Secondary Outcome

Title	DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from Baseline= Post-baseline value - time-matched baseline value, where time-matched BL value = the mean BL value for only that cohort of participants with data available at Day 85.
Time Frame	BL, Day 85

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
PCS (n=243, n=128)	5.76 (0.52)	2.12 (0.72)
MCS (n=243, n=128)	4.64 (0.63)	2.08 (0.86)
Physical Function Scale Component (n=246, n=129)	3.97 (0.51)	2.27 (0.71)
Role-Physical Scale Component (n=249, n=129)	5.88 (0.65)	2.87 (0.90)
Bodily Pain Scale Component (n=248, n=129)	8.43 (0.55)	2.81 (0.76)
General Health Scale Component (n=250, n=129)	3.65 (0.45)	1.15 (0.62)
Vitality Scale Component (n=249, n=129)	5.49 (0.57)	2.32 (0.80)
Social Functioning Scale Component (n=250, n=129)	6.83 (0.62)	2.13 (0.87)
Role-Emotional Scale Component (n=249, n=128)	4.12 (0.83)	3.14 (1.16)
Mental Health Scale Component (n=249, n=129)	4.29 (0.58)	1.70 (0.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group 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	Adj Diff: Day 85 PCS
	Estimated Value	3.63
	Confidence Interval	(2-Sided) 95%; 1.89 to 5.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adj Diff: Day 85 MCS
	Estimated Value	2.57
	Confidence Interval	(2-Sided) 95%; 0.47 to 4.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.052
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adj Diff: Day 85 Physical Function
	Estimated Value	1.70
	Confidence Interval	(2-Sided) 95%; -0.01 to 3.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adj Diff: Day 85 Role-Physical
	Estimated Value	3.01
	Confidence Interval	(2-Sided) 95%; 0.83 to 5.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group 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	Adj Diff: Day 85 Bodily Pain
	Estimated Value	5.62
	Confidence Interval	(2-Sided) 95%; 3.77 to 7.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group 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	Adj Diff: General Health
	Estimated Value	2.51
	Confidence Interval	(2-Sided) 95%; 0.99 to 4.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group 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	Adj Diff: Day 85 Vitality
	Estimated Value	3.17
	Confidence Interval	(2-Sided) 95%; 1.24 to 5.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group 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	Adj Diff: Day 85 Social Functioning
	Estimated Value	4.69
	Confidence Interval	(2-Sided) 95%; 2.59 to 6.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.494
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adj Diff: Day 85 Role Emotional
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; -1.82 to 3.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adj Diff: Day 85 Mental Health
	Estimated Value	2.59
	Confidence Interval	(2-Sided) 95%; 0.65 to 4.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

25. Secondary Outcome

Title	DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169
Description	SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
PCS (n=242, n=129)	27.36 (6.88)	27.75 (6.29)
MCS (n=242, n=129)	41.56 (12.33)	42.98 (11.90)
Physical Function Scale Component (n=247, n=130)	25.96 (8.88)	26.24 (8.37)
Role-Physical Scale Component (n=249, n=130)	30.56 (6.29)	31.93 (6.82)
Bodily Pain Scale Component (n=248, n=130)	30.54 (6.76)	31.27 (6.62)
General Health Scale Component (n=252, n=130)	34.81 (9.20)	35.05 (8.51)
Vitality Scale Component (n=252, n=130)	35.07 (8.52)	36.69 (9.06)
Social Functioning Scale Component (n=251, n=130)	33.17 (10.81)	33.84 (11.52)
Role-Emotional Scale Component (n=249, n=129)	35.96 (13.77)	36.97 (13.83)
Mental Health Scale Component (n=252, n=130)	40.50 (12.81)	42.80 (11.14)

26. Secondary Outcome

Title	DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from Baseline= Post-baseline value - time-matched baseline value, where time-matched BL value = the mean BL value for only that cohort of participants with data available at Day 169.
Time Frame	BL, Day 169

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
PCS (n=242, n=129)	6.58 (0.55)	1.12 (0.75)
MCS (n=242, n=129)	5.15 (0.64)	2.11 (0.87)
Physical Function Scale Component (n=247, n=130)	5.30 (0.58)	1.27 (0.80)
Role-Physical Scale Component (n=249, n=130)	6.52 (0.63)	1.29 (0.87)
Bodily Pain Scale Component (n=248, n=130)	8.72 (0.56)	2.48 (0.77)
General Health Scale Component (n=252, n=130)	4.02 (0.48)	0.74 (0.67)
Vitality Scale Component (n=252, n=130)	6.55 (0.60)	1.77 (0.83)
Social Functioning Scale Component (n=251, n=130)	7.31 (0.65)	2.39 (0.91)
Role-Emotional Scale Component (n=249, n=129)	6.00 (0.83)	2.46 (1.15)
Mental Health Scale Component (n=252, n=130)	4.31 (0.56)	1.61 (0.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group 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	Adj Diff: Day 169 PCS
	Estimated Value	5.46
	Confidence Interval	(2-Sided) 95%; 3.64 to 7.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adj Diff: Day 169 MCS
	Estimated Value	3.04
	Confidence Interval	(2-Sided) 95%; 0.91 to 5.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group 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	Adj Diff: Day 169 Physical Function
	Estimated Value	4.03
	Confidence Interval	(2-Sided) 95%; 2.08 to 5.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo (PLA)
	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	Adj Diff: Day 169 Role-Physical
	Estimated Value	5.22
	Confidence Interval	(2-Sided) 95%; 3.10 to 7.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	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	Adj Diff: Day 169 Bodily Pain
	Estimated Value	6.24
	Confidence Interval	(2-Sided) 95%; 4.37 to 8.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group 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	Adj Diff: Day 169 General Health
	Estimated Value	3.27
	Confidence Interval	(2-Sided) 95%; 1.64 to 4.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group 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	Adj Diff: Day 169 Vitality
	Estimated Value	4.78
	Confidence Interval	(2-Sided) 95%; 2.76 to 6.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group 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	Adj Diff: Day 169 Social Functioning
	Estimated Value	4.92
	Confidence Interval	(2-Sided) 95%; 2.71 to 7.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.013
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adj Diff: Day 169 Role Emotional
	Estimated Value	3.54
	Confidence Interval	(2-Sided) 95%; 0.74 to 6.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adj Diff: Mental Health
	Estimated Value	2.70
	Confidence Interval	(2-Sided) 95%; 0.79 to 4.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

27. Secondary Outcome

Title	DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169
Description	The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI is a weighted sum of the scale scores, with a higher score indicating poorer function. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
HAQ-DI (n=249, n=130)	1.83 (0.58)	1.82 (0.60)
HAQ dressing and grooming (n=214, n=97)	1.64 (0.75)	1.54 (0.69)
HAQ arising (n=214, n=97)	1.42 (0.72)	1.43 (0.73)
HAQ eating (n=214, n=97)	1.76 (0.83)	1.78 (0.87)
HAQ walking (n=213, n=95)	1.56 (0.70)	1.51 (0.76)
HAQ hygiene (n=213, n=97)	2.14 (0.88)	2.21 (0.87)
HAQ reaching (n=213, n=97)	2.04 (0.79)	1.97 (0.87)
HAQ gripping (n=212, n=97)	1.96 (0.53)	1.93 (0.62)
HAQ activities (n=213, n=97)	2.00 (0.79)	1.95 (0.86)

28. Secondary Outcome

Title	DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169
Description	HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.
Time Frame	BL, Day 169

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
HAQ-DI (n=249, n=130)	-0.45 (0.03)	-0.11 (0.04)
HAQ dressing and grooming (n=214, n=97)	-0.58 (0.05)	-0.26 (0.07)
HAQ arising (n=214, n=97)	-0.61 (0.04)	-0.29 (0.07)
HAQ eating (n=214, n=97)	-0.54 (0.05)	-0.07 (0.07)
HAQ walking (n=213, n=95)	-0.50 (0.05)	-0.24 (0.07)
HAQ hygiene (n=213, n=97)	-0.28 (0.05)	-0.05 (0.07)
HAQ reaching (n=213, n=97)	-0.54 (0.05)	-0.11 (0.08)
HAQ gripping (n=212, n=97)	-0.47 (0.05)	-0.15 (0.07)
HAQ activities (n=213, n=97)	-0.48 (0.05)	-0.08 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL
	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	Adj M Chg from BL: HAQ-DI
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) 95%; -0.44 to -0.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL
	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	Adj M Chg from BL: Dressing and Grooming
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95%; -0.49 to -0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL
	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	Adj M Chg from BL: Arising
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95%; -0.47 to -0.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL
	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	Adj M Chg from BL: Eating
	Estimated Value	-0.48
	Confidence Interval	(2-Sided) 95%; -0.65 to -0.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adj M Chg from BL: Walking
	Estimated Value	-0.26
	Confidence Interval	(2-Sided) 95%; -0.44 to -0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.010
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Adj M Chg from BL: Hygiene
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95%; -0.39 to -0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL
	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	Adj M Chg from BL: Reaching
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95%; -0.61 to -0.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL
	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	Adj M Chg from BL: Gripping
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95%; -0.49 to -0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Abatacept (ABA), Placebo (PLA)
	Comments	Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL
	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	Adj M Chg from BL: Activities
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 95%; -0.58 to -0.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

29. Secondary Outcome

Title	DB; Mean Disease Activity Score (DAS)28 (C-Reactive Protein [CRP]) and Mean Disease Activity Score (Erythrocyte Sedimentation Rate [ESR]) at Day 169
Description	The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline. The mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with assessments available at that visit.
Time Frame	BL, Day 169

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
Baseline DAS28 (CRP); n=251, n=130	6.53 (0.89)	6.51 (0.78)
Day 169 DAS28 (CRP); n=251, n=130	4.70 (1.45)	5.78 (1.33)
Baseline DAS28 (ESR); n=182, n=98	6.88 (0.99)	6.88 (0.92)
Day 169 DAS28 (ESR); n=182, n=98	4.90 (1.55)	6.17 (1.34)

30. Secondary Outcome

Title	DB; Adjusted Mean Change From Baseline to Day 169 in DAS28 (CRP) and DAS28 (ESR)
Description	The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.
Time Frame	BL, Day 169

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	133
DAS28 (CRP); n=251, n=130	-1.83 (0.08)	-0.74 (0.11)
DAS28 (ESR); n=182, n=98	-1.98 (0.10)	-0.71 (0.14)

31. Secondary Outcome

Title	DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
Description	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment. SAE=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.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug
Time Frame	From BL up to database lock for DB period (6/2/2004)

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	258	133
Deaths	1 0.4%	0 0%
SAEs	27 10.5%	15 11.3%
Related SAEs	7 2.7%	1 0.8%
SAEs Leading to Discontinuation	7 2.7%	2 1.5%
AEs	205 79.5%	95 71.4%
Related AEs	107 41.5%	39 29.3%
AEs Leading to Discontinuation	9 3.5%	4 3%

32. Secondary Outcome

Title	DB; Number of Participants AEs of Special Interest
Description	AE=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 are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).
Time Frame	From BL up to database lock for DB period (6/2/2004)

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	258	133
Infections	97 37.6%	43 32.3%
Neoplasms	7 2.7%	1 0.8%
Pre-specified autoimmune disorders	4 1.6%	0 0%
Acute infusional AEs	13 5%	4 3%
Peri-infusional AEs	40 15.5%	17 12.8%

33. Secondary Outcome

Title	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Description	Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). 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/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<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	From BL up to database lock for DB period (6/2/2004)

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	131
Low HGB (LLN=11.5 g/dL)	0 0%	1 0.8%
Low hematocrit (LLN=34%)	0 0%	1 0.8%
Low erythrocytes (LLN=3.8 x10*6 cells/μL)	0 0%	0 0%
Low PLT (LLN=140*10^9 cells/μL)	1 0.4%	1 0.8%
High PLT (ULN=450*10^9 cells/L)	1 0.4%	0 0%
Low leukocytes (LLN= 3.8*10^3 cells/μL)	2 0.8%	0 0%
High leukocytes (ULN = 10.6*10^3 cells/μL)	18 7%	14 10.5%
Low neutrophils+bands(LLN=1.8*10^3 cells/μL)	0 0%	0 0%
Low lymphocytes (LLN= 0.7*10^3 cells/μL)	0 0%	0 0%
High lymphocytes(ULN=4.5*10^3 cells/μL)	0 0%	0 0%
High monocytes (ULN=1*10^3 cells/μL)	0 0%	0 0%
High basophils (ULN= 0.2*10^3 cells/μL)	0 0%	0 0%
High eosinophils (ULN= 7*10^3 cells/μL)	0 0%	0 0%

34. Secondary Outcome

Title	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria
Description	Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; 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; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL
Time Frame	From BL up to database lock for DB period (6/2/2004)

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Abatacept (ABA)	Placebo (PLA)
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	256	131
High ALP (ULN=400 U/L)	0 0%	0 0%
High AST (ULN=44 U/L)	2 0.8%	2 1.5%
High ALT (ULN=55 U/L)	4 1.6%	1 0.8%
High GGT (ULN=65 U/L)	0 0%	0 0%
High bilirubin (ULN=1.2 mg/dL)	0 0%	0 0%
High BUN (ULN=26 mg/dL)	0 0%	0 0%
High creatinine (ULN=1.5 mg/dL)	11 4.3%	5 3.8%

35. Primary Outcome

Title	Open-Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation
Description	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment. SAE=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.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug
Time Frame	From first day of OL to 5.5 years

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Open-label ABA
Arm/Group Description	All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
Measure Participants	317
Deaths	6 2.3%
SAEs	136 52.7%
Related SAEs	24 9.3%
SAEs Leading to Discontinuation	20 7.8%
AEs	302 117.1%
Related AEs	192 74.4%
AEs Leading to Discontinuation	34 13.2%

36. Secondary Outcome

Title	DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)
Description	Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Time Frame	From BL to Day 169

Outcome Measure Data

Analysis Population Description

All treated participants in the double-blind period with at least 1 post-baseline immunogenicity result

Arm/Group Title	All Treated DB Participants
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive either abatacept or placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 of abatacept. Abatacept or placebo was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
Measure Participants	234
Anti-abatacept antibodies	1 0.4%
Anti-CTLA4 antibodies	2 0.8%
Total	3 1.2%

37. Primary Outcome

Title	OL; Number of Participants AEs of Special Interest
Description	AE=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 are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).
Time Frame	From first day of OL to 5.5 years

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Open-label ABA
Arm/Group Description	All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
Measure Participants	317
Infections	254 98.4%
Neoplasms (benign, malignant, and unspecified)	42 16.3%
Malignancies	21 8.1%
Pre-specified autoimmune disorders	17 6.6%
Acute infusional AEs	65 25.2%
Peri-infusional AEs	22 8.5%

38. Primary Outcome

Title	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria
Description	Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). 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/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<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	From first day of OL to 5.5 years

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Open-label ABA
Arm/Group Description	All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
Measure Participants	315
Low HGB (LLN=11.5 g/dL)	12 4.7%
Low hematocrit (LLN=34%)	18 7%
Low erythrocytes (LLN=3.8 x10*6 cells/μL)	9 3.5%
Low PLT (LLN=140*10^9 cells/L)	8 3.1%
High PLT (ULN=450*10^9 cells/L)	1 0.4%
Low leukocytes (LLN=3.8*10^3 cells/μL)	6 2.3%
High leukocytes (ULN=10.6*10^3 c/μL)	49 19%
Low neutrophils + bands (LLN=1.8*10^3 c/μL))	2 0.8%
Low lymphocytes (LLN=0.7*10^3 cells/μL)	61 23.6%
High lymphocytes (ULN=4.5*10^3 cells/μL)	0 0%
High monocytes (ULN=1*10^3 cells/μL)	2 0.8%
High basophils (ULN=0.2*10^3 cells/μL)	0 0%
High eosinophils (ULN=7*10^3 cells/μL)	31 12%

39. Primary Outcome

Title	OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria
Description	Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; 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; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL
Time Frame	From first day of OL to 5.5 years

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Open-label ABA
Arm/Group Description	All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
Measure Participants	315
High ALP (ULN=400 U/L)	3 1.2%
High AST (ULN=44 U/L)	12 4.7%
High ALT (ULN=55 U/L)	12 4.7%
High GGT (ULN=65 U/L)	30 11.6%
High bilirubin (ULN=1.2 mg/dL)	2 0.8%
High BUN (ULN=26 mg/dL)	20 7.8%
High creatinine (ULN=1.5 mg/dL)	77 29.8%

40. Primary Outcome

Title	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL
Description	Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with serum samples available at that visit.
Time Frame	Baseline and Days 169, 365, 729, and 1093

Outcome Measure Data

Analysis Population Description

All treated participants with available serum samples. N=the total number of participants analyzed, n=the number of participants at that time point with available serum samples. Mean time-matched baseline values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	201	96
Day 169 cohort (n=201, n=96): IgA	327.9 (170.8)	326.9 (203.3)
Day 169 cohort (n=201, n=96): IgG	1346.0 (473.0)	1364.0 (532.2)
Day 169 cohort (n=201, n=96): IgM	180.1 (128.3)	160.1 (86.91)
Day 365 cohort (n=182, n=84): IgA	337.6 (173.0)	318.6 (204.4)
Day 365 cohort (n=182, n=84): IgG	1320.0 (421.2)	1341.0 (525.9)
Day 365 cohort (n=182, n=84): IgM	175.7 (113.5)	159.5 (88.33)
Day 729 cohort (n=163, n=75): IgA	322.2 (156.8)	327.6 (218.5)
Day 729 cohort (n=163, n=75): IgG	1337.0 (421.4)	1338.0 (528.7)
Day 729 cohort (n=163, n=75): IgM	184.1 (137.0)	165.9 (91.12)
Day 1093 cohort (n=76, n=42): IgG	294.1 (128.6)	329.6 (167.8)
Day 1093 cohort (n=76, n=42): IgG	1374.0 (537.3)	1478.0 (562.9)
Day 1093 cohort (n=76, n=42): IgM	175.5 (158.1)	174.2 (89.43)

41. Primary Outcome

Title	OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL
Description	Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with serum samples available at that visit.
Time Frame	BL, Days 169, 365, 729, and 1093

Outcome Measure Data

Analysis Population Description

All treated participants with available serum samples. N=the total number of participants analyzed, n=the number of participants at that time point with available serum samples. Mean time-matched baseline values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	201	96
Day 169 cohort (n=201, n=96): IgA	-35.3 (3.61)	1.10 (8.12)
Day 169 cohort (n=201, n=96): IgG	-233.0 (19.54)	-72.8 (35.74)
Day 169 cohort (n=201, n=96): IgM	-17.8 (3.59)	-5.42 (3.63)
Day 365 cohort (n=182, n=84): IgA	-37.5 (4.93)	-33.0 (10.12)
Day 365 cohort (n=182, n=84): IgG	-282.0 (18.60)	-251.0 (39.41)
Day 365 cohort (n=182, n=84): IgM	-23.0 (4.21)	-18.3 (4.21)
Day 729 cohort (n=163, n=75): IgA	-37.3 (6.13)	-30.0 (10.42)
Day 729 cohort (n=163, n=75): IgG	-344.0 (2.81)	-257.0 (38.30)
Day 729 cohort (n=163, n=75): IgM	-19.4 (6.01)	-16.1 (6.02)
Day 1093 cohort (n=76, n=41): IgA	-35.6 (7.50)	-69.4 (16.83)
Day 1093 cohort (n=76, n=42): IgG	-396.0 (46.77)	-377.0 (55.94)
Day 1093 cohort (n=76, n=42): IgM	-29.7 (9.03)	-24.7 (9.51)

42. Secondary Outcome

Title	OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL
Description	ACR 20/50/70 response requires a participant to have a 20/50/70% reduction in the number of swollen and tender joints, and a reduction of 20/50/70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant 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 20/50/70 response if the participant had ACR 20/50/70 observed for at least 2 consecutive study visits.
Time Frame	Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	214	98
Day 15 ACR 20 (n=214, n=97)	43 16.7%	6 4.5%
Day 15 ACR 50 (n=213, n=97)	5 1.9%	0 0%
Day 15 ACR 70 (n=214, n=97)	1 0.4%	0 0%
Day 29 ACR 20 (n=210, n=97)	77 29.8%	23 17.3%
Day 29 ACR 50 (n=213, n=97)	20 7.8%	4 3%
Day 29 ACR 70 (n=213, n=97)	4 1.6%	1 0.8%
Day 57 ACR 20 (n=211, n=98)	109 42.2%	30 22.6%
Day 57 ACR 50 (n=213, n=98)	31 12%	9 6.8%
Day 57 ACR 70 (n=213, n=98)	11 4.3%	0 0%
Day 85 ACR 20 (n=211, n=97)	113 43.8%	22 16.5%
Day 85 ACR 50 (n=211, n=97)	44 17.1%	8 6%
Day 85 ACR 70 (n=212, n=98)	15 5.8%	1 0.8%
Day 113 ACR 20 (n=203, n=95)	120 46.5%	31 23.3%
Day 113 ACR 50 (n=206, n=97)	42 16.3%	5 3.8%
Day 113 ACR 70 (n=206, n=97)	20 7.8%	0 0%
Day 141 ACR 20 (n=212, n=96)	136 52.7%	26 19.5%
Day 141 ACR 50 (n=214, n=97)	62 24%	6 4.5%
Day 141 ACR 70 (n=214, n=97)	25 9.7%	0 0%
Day 169 ACR 20 (n=208, n=98)	125 48.4%	26 19.5%
Day 169 ACR 50 (n=209, n=98)	50 19.4%	5 3.8%
Day 169 ACR 70 (n=212, n=98)	25 9.7%	2 1.5%
Day 253 ACR 20 (n=203, n=95)	127 49.2%	49 36.8%
Day 253 ACR 50 (n=199, n=97)	58 22.5%	28 21.1%
Day 253 ACR 70 (n=204, n=98)	25 9.7%	10 7.5%
Day 365 ACR 20 (n=198, n=96)	129 50%	63 47.4%
Day 365 ACR 50 (n=201, n=95)	65 25.2%	37 27.8%
Day 365 ACR 70 (n=202, n=96)	37 14.3%	13 9.8%
Day 449 ACR 20 (n=181, n=82)	124 48.1%	61 45.9%
Day 449 ACR 50 (n=181, n=85)	73 28.3%	37 27.8%
Day 449 ACR 70 (n=182, n=85)	32 12.4%	18 13.5%
Day 533 ACR 20 (n=168, n=76)	115 44.6%	53 39.8%
Day 533 ACR 50 (n=169, n=77)	71 27.5%	30 22.6%
Day 533 ACR 70 (n=171, n=78)	36 14%	10 7.5%
Day 617 ACR 20 (n=163, n=72)	120 46.5%	55 41.4%
Day 617 ACR 50 (n=161, n=70)	73 28.3%	32 24.1%
Day 617 ACR 70 (n=162, n=71)	33 12.8%	13 9.8%
Day 729 ACR 20 (n=156, n=71)	117 45.3%	49 36.8%
Day 729 ACR 50 (n=153, n=72)	70 27.1%	30 22.6%
Day 729 ACR 70 (n=155, n=74)	35 13.6%	13 9.8%
Day 813 ACR 20 (n=140, n=60)	105 40.7%	47 35.3%
Day 813 ACR 50 (n=141, n=61)	62 24%	23 17.3%
Day 813 ACR 70 (n=143, n=62)	28 10.9%	6 4.5%
Day 897 ACR 20 (n=134, n=62)	107 41.5%	45 33.8%
Day 897 ACR 50 (n=137, n=61)	64 24.8%	29 21.8%
Day 897 ACR 70 (n=138, n=62)	27 10.5%	8 6%
Day 981 ACR 20 (n=140, n=57)	104 40.3%	40 30.1%
Day 981 ACR 50 (n=143, n=58)	66 25.6%	25 18.8%
Day 981 ACR 70 (n=140, n=60)	31 12%	9 6.8%
Day 1093 ACR 20 (n=134, n=55)	109 42.2%	44 33.1%
Day 1093 ACR 50 (n=137, n=57)	70 27.1%	29 21.8%
Day 1093 ACR 70 (n=137, n=58)	32 12.4%	16 12%
Day 1261 ACR 20 (n=126, n=52)	99 38.4%	42 31.6%
Day 1261 ACR 50 (n=126, n=53)	60 23.3%	24 18%
Day 1261 ACR 70 (n=130, n=55)	27 10.5%	15 11.3%
Day 1457 ACR 20 (n=115, n=50)	87 33.7%	41 30.8%
Day 1457 ACR 50 (n=115, n=50)	53 20.5%	24 18%
Day 1457 ACR 70 (n=118, n=50)	22 8.5%	11 8.3%
Day 1625 ACR 20 (n=110, n=49)	89 34.5%	33 24.8%
Day 1625 ACR 50 (n=111, n=48)	50 19.4%	19 14.3%
Day 1625 ACR 70 (n=112, n=49)	26 10.1%	12 9%
Day 1821 ACR 20 (n=106, n=46)	81 31.4%	35 26.3%
Day 1821 ACR 50 (n=106, n=47)	55 21.3%	24 18%
Day 1821 ACR 70 (n=109, n=47)	24 9.3%	10 7.5%

43. Secondary Outcome

Title	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL
Description	The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.
Time Frame	Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	213	98
Day 15 LDAS (n=209, n=95)	5 1.9%	0 0%
Day 15 Remission (n=209, n=95)	1 0.4%	0 0%
Day 29 LDAS (n=206, n=96)	10 3.9%	1 0.8%
Day 29 Remission (n=206, n=96)	5 1.9%	1 0.8%
Day 57 LDAS (n=210, n=97)	19 7.4%	5 3.8%
Day 57 Remission (n=210, n=97)	11 4.3%	1 0.8%
Day 85 LDAS (n=212, n=98)	22 8.5%	4 3%
Day 85 Remission (n=212, n=98)	11 4.3%	3 2.3%
Day 113 LDAS (n=202, n=93)	28 10.9%	4 3%
Day 113 Remission (n=202, n=93)	11 4.3%	0 0%
Day 141 LDAS (n=213, n=96)	41 15.9%	4 3%
Day 141 Remission (n=213, n=96)	15 5.8%	2 1.5%
Day 169 LDAS (n=208, n=96)	38 14.7%	5 3.8%
Day 169 Remission (n=208, n=96)	23 8.9%	1 0.8%
Day 253 LDAS (n=195, n=89)	33 12.8%	19 14.3%
Day 253 Remission (n=195, n=89)	19 7.4%	12 9%
Day 365 LDAS (n=194, n=93)	47 18.2%	22 16.5%
Day 365 Remission (n=194, n=93)	27 10.5%	17 12.8%
Day 449 LDAS (n=170, n=76)	48 18.6%	25 18.8%
Day 449 Remission (n=170, n=76)	24 9.3%	15 11.3%
Day 533 LDAS (n=164, n=73)	46 17.8%	21 15.8%
Day 533 Remission (n=164, n=73)	26 10.1%	13 9.8%
Day 617 LDAS (n=164, n=69)	51 19.8%	23 17.3%
Day 617 Remission (n=164, n=69)	29 11.2%	13 9.8%
Day 729 LDAS (n=153, n=68)	49 19%	12 9%
Day 729 Remission (n=153, n=68)	31 12%	7 5.3%
Day 813 LDAS (n=139, n=58)	43 16.7%	16 12%
Day 813 Remission (n=139, n=58)	26 10.1%	6 4.5%
Day 897 LDAS (n=134, n=60)	50 19.4%	14 10.5%
Day 897 Remission (n=134, n=60)	26 10.1%	8 6%
Day 981 LDAS (n=121, n=49)	47 18.2%	14 10.5%
Day 981 Remission (n=121, n=49)	28 10.9%	7 5.3%
Day 1093 LDAS (n=134, n=56)	50 19.4%	15 11.3%
Day 1093 Remission (n=134, n=56)	31 12%	8 6%
Day 1261 LDAS (n=126, n=51)	50 19.4%	19 14.3%
Day 1261 Remission (n=126, n=51)	25 9.7%	9 6.8%
Day 1457 LDAS (n=115, n=50)	46 17.8%	14 10.5%
Day 1457 Remission (n=115, n=50)	24 9.3%	9 6.8%
Day 1625 LDAS (n=107, n=46)	40 15.5%	14 10.5%
Day 1625 Remission (n=107, n=46)	28 10.9%	11 8.3%
Day 1821 LDAS (n=103, n=45)	38 14.7%	12 9%
Day 1821 Remission (n=103, n=45)	23 8.9%	10 7.5%

44. Secondary Outcome

Title	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL
Description	The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	209	98
Day 15 cohort (n=206, n=95)	6.52 (0.84)	6.46 (0.81)
Day 29 cohort (n=204, n=96)	6.53 (0.86)	6.46 (0.82)
Day 57 cohort (n=207, n=97)	6.51 (0.84)	6.43 (0.81)
Day 85 cohort (n=209, n=98)	6.55 (0.84)	6.45 (0.82)
Day 113 cohort (n=199, n=93)	6.55 (0.85)	6.49 (0.80)
Day 141 cohort (n=210, n=96)	6.53 (0.85)	6.43 (0.82)
Day 169 cohort (n=205, n=96)	6.54 (0.85)	6.44 (0.81)
Day 253 cohort (n=193, n=89)	6.53 (0.86)	6.44 (0.79)
Day 365 cohort (n=192, n=93)	6.51 (0.85)	6.43 (0.83)
Day 449 cohort (n=168, n=76)	6.52 (0.86)	6.42 (0.83)
Day 533 cohort (n=162, n=73)	6.52 (0.85)	6.45 (0.78)
Day 617 cohort (n=163, n=69)	6.51 (0.82)	6.49 (0.75)
Day 729 cohort (n=151, n=68)	6.50 (0.84)	6.52 (0.76)
Day 813 cohort (n=137, n=58)	6.47 (0.83)	6.56 (0.78)
Day 897 cohort (n=132, n=60)	6.43 (0.82)	6.61 (0.73)
Day 981 cohort (n=119, n=49)	6.46 (0.84)	6.56 (0.72)
Day 1093 cohort (n=133, n=56)	6.49 (0.81)	6.53 (0.77)
Day 1261 cohort (n=124, n=51)	6.42 (0.83)	6.50 (0.76)
Day 1457 cohort (n=113, n=50)	6.41 (0.83)	6.54 (0.77)
Day 1625 cohort (n=105, n=46)	6.44 (0.85)	6.50 (0.79)
Day 1821 cohort (n=101, n=45)	6.47 (0.82)	6.54 (0.78)

45. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL
Description	DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	209	98
Day 15 cohort (n=206, n=95)	-0.74 (0.06)	-0.40 (0.08)
Day 29 cohort (n=204, n=96)	-1.15 (0.07)	-0.72 (0.11)
Day 57 cohort (n=207, n=97)	-1.59 (0.08)	-1.05 (0.12)
Day 85 cohort (n=209, n=98)	-1.75 (0.08)	-0.88 (0.12)
Day 113 cohort (n=199, n=93)	-1.92 (0.09)	-1.00 (0.13)
Day 141 cohort (n=210, n=96)	-2.03 (0.09)	-1.05 (0.13)
Day 169 cohort (n=205, n=96)	-2.00 (0.10)	-0.93 (0.12)
Day 253 cohort (n=193, n=89)	-2.11 (0.09)	-2.03 (0.15)
Day 365 cohort (n=192, n=93)	-2.33 (0.10)	-2.13 (0.15)
Day 449 cohort (n=168, n=76)	-2.43 (0.11)	-2.49 (0.15)
Day 533 cohort (n=162, n=73)	-2.57 (0.11)	-2.50 (0.16)
Day 617 cohort (n=163, n=69)	-2.65 (0.10)	-2.58 (0.14)
Day 729 cohort (n=151, n=68)	-2.66 (0.11)	-2.23 (0.17)
Day 813 cohort (n=137, n=58)	-2.70 (0.12)	-2.40 (0.15)
Day 897 cohort (n=132, n=60)	-2.73 (0.11)	-2.61 (0.16)
Day 981 cohort (n=119, n=49)	-2.76 (0.13)	-2.66 (0.17)
Day 1093 cohort (n=133, n=56)	-2.84 (0.12)	-2.62 (0.20)
Day 1261 cohort (n=124, n=51)	-2.83 (0.12)	-2.85 (0.18)
Day 1457 cohort (n=113, n=50)	-2.78 (0.13)	-2.78 (0.19)
Day 1625 cohort (n=105, n=46)	-2.88 (0.13)	-2.80 (0.20)
Day 1821 cohort (n=101, n=45)	-2.89 (0.14)	-2.98 (0.18)

46. Secondary Outcome

Title	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL
Description	The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	178	83
Day 169 cohort (n=178, n=83)	6.89 (1.00)	6.83 (0.98)
Day 253 cohort (n=163, n=75)	6.87 (1.00)	6.85 (1.01)
Day 365 cohort (n=176, n=82)	6.91 (1.01)	6.80 (1.03)
Day 449 cohort (n=152, n=70)	6.94 (0.99)	6.85 (0.97)
Day 533 cohort (n=134, n=66)	6.89 (1.02)	6.81 (0.81)
Day 617 cohort (n=143, n=59)	6.86 (0.98)	6.88 (0.82)
Day 729 cohort (n=133, n=64)	6.85 (1.01)	6.86 (0.89)
Day 813 cohort (n=120, n=52)	6.84 (0.94)	6.93 (0.93)
Day 897 cohort (n=118, n=56)	6.78 (0.96)	6.93 (0.85)
Day 981 cohort (n=119, n=50)	6.85 (0.96)	6.91 (0.84)
Day 1093 cohort (n=111, n=50)	6.84 (0.95)	6.92 (0.88)
Day 1261 cohort (n=107, n=50)	6.77 (0.97)	6.88 (0.87)
Day 1457 cohort (n=94, n=45)	6.80 (0.99)	6.87 (0.89)
Day 1625 cohort (n=89, n=41)	6.81 (0.99)	6.89 (0.90)
Day 1821 cohort (n=87, n=42)	6.85 (0.99)	6.91 (0.91)

47. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL
Description	DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	178	83
Day 169 cohort (n=178, n=83)	-2.05 (0.12)	-0.83 (0.14)
Day 253 cohort (n=163, n=75)	-2.09 (0.11)	-2.00 (0.16)
Day 365 cohort (n=176, n=82)	-2.31 (0.11)	-2.05 (0.17)
Day 449 cohort (n=152, n=70)	-2.48 (0.12)	-2.53 (0.16)
Day 533 cohort (n=134, n=66)	-2.48 (0.13)	-2.59 (0.16)
Day 617 cohort (n=143, n=59)	-2.65 (0.12)	-2.60 (0.15)
Day 729 cohort (n=133, n=64)	-2.65 (0.12)	-2.25 (0.16)
Day 813 cohort (n=120, n=52)	-2.77 (0.13)	-2.43 (0.16)
Day 897 cohort (n=118, n=56)	-2.65 (0.12)	-2.70 (0.17)
Day 981 cohort (n=119, n=50)	-2.77 (0.13)	-2.59 (0.20)
Day 1093 cohort (n=111, n=50)	-2.78 (0.14)	-2.56 (0.23)
Day 1261 cohort (n=107, n=50)	-2.70 (0.15)	-2.56 (0.21)
Day 1457 cohort (n=94, n=45)	-2.68 (0.15)	-2.58 (0.22)
Day 1625 cohort (n=89, n=41)	-2.69 (0.15)	-2.64 (0.24)
Day 1821 cohort (n=87, n=42)	-2.77 (0.15)	-2.73 (0.22)

48. Secondary Outcome

Title	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL
Description	The HAQ disability index (HAQ DI) is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time Frame	Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants analyzed, n=number of participants with measurements at visit.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	209	98
Day 15 (n=209, n=96)	59 22.9%	16 12%
Day 29 (n=207, n=97)	82 31.8%	30 22.6%
Day 57 (n=209, n=98)	101 39.1%	34 25.6%
Day 85 (n=207, n=97)	119 46.1%	28 21.1%
Day 113 (n=202, n=96)	113 43.8%	30 22.6%
Day 141 (n=209, n=97)	115 44.6%	29 21.8%
Day 169 (n=207, n=98)	115 44.6%	31 23.3%
Day 253 (n=199, n=93)	111 43%	47 35.3%
Day 365 (n=182, n=87)	128 49.6%	49 36.8%
Day 449 (n=182, n=87)	108 41.9%	47 35.3%
Day 533 (n=165, n=78)	99 38.4%	44 33.1%
Day 617 (n=161, n=71)	101 39.1%	40 30.1%
Day 729 (n=154, n=74)	101 39.1%	46 34.6%
Day 813 (n=139, n=61)	88 34.1%	34 25.6%
Day 897 (n=132, n=62)	87 33.7%	37 27.8%
Day 981 (n=141, n=59)	92 35.7%	37 27.8%
Day 1093 (n=128, n=54)	88 34.1%	34 25.6%
Day 1261 (n=126, n=56)	80 31%	41 30.8%
Day 1457 (n=117, n=50)	81 31.4%	34 25.6%
Day 1625 (n=109, n=49)	69 26.7%	31 23.3%
Day 1821 (n=104, n=47)	65 25.2%	31 23.3%

49. Secondary Outcome

Title	OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL
Description	The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI is a weighted sum of the scale scores, with a higher score indicating poorer function. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	209	98
Day 169 HAQ-DI (n=207, n=98)	1.82 (0.54)	1.79 (0.60)
Day 169 Dressing and Grooming (n=209, n=98)	1.65 (0.73)	1.54 (0.69)
Day 169 Arising (n=209, n=98)	1.41 (0.72)	1.44 (0.73)
Day 169 Eating (n=209, n=98)	1.75 (0.84)	1.80 (0.87)
Day 169 Walking (n=208, n=96)	1.57 (0.71)	1.51 (0.75)
Day 169 Hygiene (n=208, n=98)	2.14 (0.88)	2.21 (0.86)
Day 169 Reaching (n=208, n=98)	2.04 (0.79)	1.97 (0.87)
Day 169 Gripping (n=207, n=98)	1.95 (0.53)	1.92 (0.62)
Day 169 Activities (n=208, n=98)	2.01 (0.77)	1.96 (0.86)
Day 365 HAQ-DI (n=199, n=97)	1.80 (0.56)	1.80 (0.60)
Day 365 Dressing and Grooming (n=201, n=97)	1.62 (0.74)	1.55 (0.69)
Day 365 Arising (n=201, n=97)	1.39 (0.71)	1.45 (0.74)
Day 365 Eating (n=201, n=97)	1.73 (0.84)	1.80 (0.87)
Day 365 Walking (n=199, n=95)	1.55 (0.73)	1.51 (0.76)
Day 365 Hygiene (n=201, n=97)	2.14 (0.89)	2.22 (0.87)
Day 365 Reaching (n=201, n=97)	2.03 (0.81)	1.98 (0.97)
Day 365 Gripping (n=200, n=97)	1.94 (0.55)	1.92 (0.62)
Day 365 Activities (n=200, n=97)	2.02 (0.80)	1.96 (0.85)
Day 729 HAQ-DI (n=154, n=74)	1.77 (0.57)	1.79 (0.59)
Day 729 Dressing and Grooming (n=156, n=74)	1.62 (0.74)	1.54 (0.67)
Day 729 Arising (n=156, n=74)	1.37 (0.72)	1.43 (0.70)
Day 729 Eating (n=156, n=74)	1.69 (0.86)	1.81 (0.84)
Day 729 Walking (n=156, n=72)	1.53 (0.74)	1.47 (0.73)
Day 729 Hygiene (n=154, n=74)	2.07 (0.91)	2.23 (0.88)
Day 729 Reaching (n=154, n=74)	1.98 (0.83)	2.03 (0.83)
Day 729 Gripping (n=154, n=74)	1.94 (0.55)	1.88 (0.57)
Day 729 Activities (n=154, n=74)	2.01 (0.80)	1.93 (0.85)
Day 1093 HAQ-DI (n=128, n=54)	1.78 (0.57)	1.81 (0.54)
Day 1093 Dressing and Grooming (n=129, n=54)	1.62 (0.75)	1.59 (0.57)
Day 1093 Arising (n=129, n=54)	1.38 (0.72)	1.44 (0.72)
Day 1093 Eating (n=129, n=54)	1.68 (0.84)	1.81 (0.80)
Day 1093 Walking (n=129, n=54)	1.55 (0.73)	1.43 (0.69)
Day 1093 Hygiene (n=135, n=59)	2.04 (0.91)	2.25 (0.86)
Day 1093 Reaching (n=135, n=59)	1.95 (0.83)	2.14 (0.78)
Day 1093 Gripping (n=135, n=59)	1.95 (0.52)	1.93 (0.49)
Day 1093 Activities (n=135, n=59)	1.96 (0.78)	1.98 (0.80)
Day 1457 HAQ-DI (n=117, n=50)	1.75 (0.58)	1.87 (0.54)
Day 1457 Dressing and Grooming (n=117, n=50)	1.64 (0.74)	1.64 (0.56)
Day 1457 Arising (n=117, n=50)	1.35 (0.71)	1.44 (0.73)
Day 1457 Eating (n=117, n=50)	1.67 (0.85)	1.92 (0.85)
Day 1457 Walking (n=117, n=50)	1.50 (0.71)	1.48 (0.71)
Day 1457 Hygiene (n=118, n=50)	2.06 (0.89)	2.32 (0.82)
Day 1457 Reaching (n=118, n=50)	1.97 (0.83)	2.12 (0.80)
Day 1457 Gripping (n=118, n=50)	1.93 (0.55)	1.98 (0.43)
Day 1457 Activities (n=118, n=50)	1.92 (0.81)	2.02 (0.82)
Day 1821 HAQ-DI (n=104, n=47)	1.75 (0.61)	1.84 (0.57)
Day 1821 Dressing and Grooming (n=105, n=47)	1.65 (0.77)	1.62 (0.57)
Day 1821 Arising (n=105, n=47)	1.38 (0.73)	1.43 (0.74)
Day 1821 Eating (n=105, n=47)	1.62 (0.86)	1.89 (0.89)
Day 1821 Walking (n=103, n=47)	1.51 (0.68)	1.45 (0.72)
Day 1821 Hygiene (n=104, n=47)	2.02 (0.90)	2.26 (0.85)
Day 1821 Reaching (n=104, n=47)	1.94 (0.85)	2.11 (0.81)
Day 1821 Gripping (n=104, n=47)	1.93 (0.60)	1.94 (0.53)
Day 1821 Activities (n=104, n=47)	1.93 (0.80)	2.00 (0.86)

50. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL
Description	HAQ-DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit
Time Frame	BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	209	98
Day 169 HAQ-DI (n=207, n=98)	-0.51 (0.04)	-0.16 (0.04)
Day 169 Dressing and Grooming (n=209, n=98)	-0.60 (0.06)	-0.26 (0.07)
Day 169 Arising (n=209, n=98)	-0.61 (0.05)	-0.31 (0.07)
Day 169 Eating (n=209, n=98)	-0.53 (0.06)	-0.09 (0.06)
Day 169 Walking (n=208, n=96)	-0.52 (0.05)	-0.23 (0.07)
Day 169 Hygiene (n=208, n=98)	-0.28 (0.05)	-0.08 (0.07)
Day 169 Reaching (n=208, n=98)	-0.55 (0.06)	-0.11 (0.06)
Day 169 Gripping (n=207, n=98)	-0.46 (0.06)	-0.14 (0.06)
Day 169 Activities (n=208, n=98)	-0.50 (0.06)	-0.09 (0.06)
Day 365 HAQ-DI (n=199, n=97)	-0.52 (0.04)	-0.40 (0.05)
Day 365 Dressing and Grooming (n=201, n=97)	-0.58 (0.06)	-0.44 (0.08)
Day 365 Arising (n=201, n=97)	-0.50 (0.06)	-0.55 (0.07)
Day 365 Eating (n=201, n=97)	-0.57 (0.06)	-0.47 (0.08)
Day 365 Walking (n=199, n=95)	-0.50 (0.06)	-0.55 (0.08)
Day 365 Hygiene (n=201, n=97)	-0.36 (0.06)	-0.28 (0.08)
Day 365 Reaching (n=201, n=97)	-0.59 (0.06)	-0.33 (0.09)
Day 365 Gripping (n=200, n=97)	-0.55 (0.06)	-0.28 (0.07)
Day 365 Activities (n=200, n=97)	-0.51 (0.06)	-0.34 (0.08)
Day 729 HAQ-DI (n=154, n=74)	-0.62 (0.05)	-0.50 (0.07)
Day 729 Dressing and Grooming (n=156, n=74)	-0.74 (0.07)	-0.59 (0.10)
Day 729 Arising (n=156, n=74)	-0.62 (0.06)	-0.64 (0.08)
Day 729 Eating (n=156, n=74)	-0.69 (0.07)	-0.54 (0.09)
Day 729 Walking (n=156, n=72)	-0.59 (0.07)	-0.49 (0.10)
Day 729 Hygiene (n=154, n=74)	-0.35 (0.07)	-0.36 (0.11)
Day 729 Reaching (n=154, n=74)	-0.64 (0.07)	-0.51 (0.10)
Day 729 Gripping (n=154, n=74)	-0.62 (0.08)	-0.43 (0.09)
Day 729 Activities (n=154, n=74)	-0.62 (0.06)	-0.46 (0.11)
Day 1093 HAQ-DI (n=128, n=54)	-0.65 (0.05)	-0.51 (0.07)
Day 1093 Dressing and Grooming (n=129, n=54)	-0.74 (0.07)	-0.65 (0.11)
Day 1093 Arising (n=129, n=54)	-0.67 (0.07)	-0.72 (0.10)
Day 1093 Eating (n=129, n=54)	-0.71 (0.07)	-0.57 (0.10)
Day 1093 Walking (n=129, n=54)	-0.64 (0.08)	-0.52 (0.11)
Day 1093 Hygiene (n=135, n=59)	-0.36 (0.07)	-0.37 (0.13)
Day 1093 Reaching (n=135, n=59)	-0.63 (0.07)	-0.59 (0.10)
Day 1093 Gripping (n=135, n=59)	-0.69 (0.08)	-0.31 (0.08)
Day 1093 Activities (n=135, n=59)	-0.64 (0.07)	-0.54 (0.10)
Day 1457 HAQ-DI (n=117, n=50)	-0.58 (0.05)	-0.62 (0.09)
Day 1457 Dressing and Grooming (n=117, n=50)	-0.74 (0.08)	-0.76 (0.12)
Day 1457 Arising (n=117, n=50)	-0.60 (0.07)	-0.74 (0.13)
Day 1457 Eating (n=117, n=50)	-0.64 (0.08)	-0.70 (0.14)
Day 1457 Walking (n=117, n=50)	-0.50 (0.08)	-0.64 (0.13)
Day 1457 Hygiene (n=118, n=50)	-0.29 (0.08)	-0.54 (0.14)
Day 1457 Reaching (n=118, n=50)	-0.68 (0.07)	-0.60 (0.13)
Day 1457 Gripping (n=118, n=50)	-0.55 (0.08)	-0.38 (0.11)
Day 1457 Activities (n=118, n=50)	-0.59 (0.08)	-0.56 (0.11)
Day 1821 HAQ-DI (n=104, n=47)	-0.57 (0.06)	-0.66 (0.09)
Day 1821 Dressing and Grooming (n=105, n=47)	-0.75 (0.08)	-0.83 (0.12)
Day 1821 Arising (n=105, n=47)	-0.59 (0.08)	-0.79 (0.12)
Day 1821 Eating (n=105, n=47)	-0.54 (0.08)	-0.87 (0.12)
Day 1821 Walking (n=103, n=47)	-0.54 (0.09)	-0.57 (0.12)
Day 1821 Hygiene (n=104, n=47)	-0.27 (0.09)	-0.57 (0.16)
Day 1821 Reaching (n=104, n=47)	-0.68 (0.09)	-0.62 (0.10)
Day 1821 Gripping (n=104, n=47)	-0.58 (0.09)	-0.40 (0.11)
Day 1821 Activities (n=104, n=47)	-0.59 (0.08)	-0.64 (0.12)

51. Secondary Outcome

Title	OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL
Description	RF is an autoantibody most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. Time-matched baseline levels of RF were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	191	95
Day 169 cohort (n=191, n=95)	262.4 (487.9)	264.8 (430.4)
Day 365 cohort (n=189, n=92)	275.5 (505.4)	270.4 (435.9)
Day 729 cohort (n=150, n=71)	276.8 (513.1)	301.5 (476.4)
Day 1093 cohort (n=123, n=57)	234.6 (404.4)	328.9 (509.8)
Day 1457 cohort (n=106, n=46)	247.8 (368.0)	331.3 (552.9)
Day 1821 cohort (n=97, n=45)	214.8 (348.4)	318.4 (552.3)

52. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL
Description	RF is an autoantibody most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	191	95
Day 169 cohort (n=191, n=95)	-80.4 (20.17)	-25.1 (18.54)
Day 365 cohort (n=189, n=92)	-50.0 (28.64)	-69.6 (24.58)
Day 729 cohort (n=150, n=71)	-30.2 (40.77)	-82.8 (41.86)
Day 1093 cohort (n=123, n=57)	-6.70 (46.76)	-86.5 (65.61)
Day 1457 cohort (n=106, n=46)	6.79 (42.12)	-68.1 (86.80)
Day 1821 cohort (n=97, n=45)	-10.7 (32.57)	-103.0 (83.56)

53. Secondary Outcome

Title	OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL
Description	CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Time-matched baseline levels of CRP were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	210	99
Day 169 cohort (n=210, n=99)	46.00 (38.77)	33.34 (31.13)
Day 365 cohort (n=196, n=95)	45.62 (39.31)	34.05 (31.55)
Day 729 cohort (n=158, n=71)	45.61 (39.11)	34.60 (30.69)
Day 1093 cohort (n=139, n=59)	43.20 (37.17)	35.07 (29.95)
Day 1457 cohort (n=125, n=52)	41.98 (36.52)	35.30 (30.87)
Day 1821 cohort (n=108, n=46)	41.23 (35.71)	34.83 (28.26)

54. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL
Description	CRP is an acute phase reactant protein that is a clinical marker for RA. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	210	99
Day 169 cohort (n=210, n=99)	-25.3 (2.70)	-0.36 (3.24)
Day 365 cohort (n=196, n=95)	-29.1 (2.72)	-16.8 (3.07)
Day 729 cohort (n=158, n=71)	-29.4 (3.30)	-10.8 (4.68)
Day 1093 cohort (n=139, n=59)	-31.8 (3.08)	-18.8 (3.23)
Day 1457 cohort (n=125, n=52)	-30.1 (3.30)	-22.8 (4.86)
Day 1821 cohort (n=108, n=46)	-30.1 (3.47)	-23.2 (4.33)

55. Secondary Outcome

Title	OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL
Description	ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Time-matched baseline levels of ESR were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	174	81
Day 169 cohort (n=174, n=81)	50.60 (28.06)	44.40 (26.64)
Day 365 cohort (n=171, n=81)	50.51 (28.61)	44.10 (26.41)
Day 729 cohort (n=135, n=67)	50.53 (28.52)	42.06 (23.77)
Day 1093 cohort (n=113, n=53)	49.03 (26.11)	43.36 (24.42)
Day 1457 cohort (n=99, n=45)	50.04 (26.91)	42.64 (25.76)
Day 1821 cohort (n=90, n=43)	50.32 (26.41)	43.02 (24.96)

56. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL
Description	ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	174	81
Day 169 cohort (n=174, n=81)	-18.0 (1.89)	-0.44 (2.60)
Day 365 cohort (n=171, n=81)	-18.8 (1.97)	-10.1 (2.50)
Day 729 cohort (n=135, n=67)	-20.2 (2.48)	-6.25 (3.15)
Day 1093 cohort (n=113, n=53)	-19.9 (2.54)	-10.6 (3.60)
Day 1457 cohort (n=99, n=45)	-20.5 (2.56)	-9.80 (4.44)
Day 1821 cohort (n=90, n=43)	-19.5 (2.79)	-9.49 (4.45)

57. Secondary Outcome

Title	OL; Mean Time-matched Baseline Levels of Soluble Interleukin 2 Receptor (sIL-2R) Over Time For Participants Treated in the OL
Description	IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Time-matched baseline levels of IL-2R were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	198	91
Day 169 cohort (n=198, n=91)	1879.0 (909.3)	1805.0 (922.9)
Day 365 cohort (n=183, n=88)	1851.0 (762.5)	1800.0 (941.5)
Day 729 cohort (n=135, n=66)	1942.0 (971.5)	1708.0 (864.9)
Day 1093 cohort (n=72, n=36)	1813.0 (781.8)	1827.0 (974.2)

58. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in Levels of sIL-2R Over Time For Participants Treated in the OL
Description	IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	198	91
Day 169 cohort (n=198, n=91)	-590.0 (41.75)	-19.6 (73.21)
Day 365 cohort (n=183, n=88)	-522.0 (50.84)	-424.0 (71.42)
Day 729 cohort (n=135, n=66)	-836.0 (58.94)	-483.0 (101.6)
Day 1093 cohort (n=72, n=36)	-761.0 (92.88)	-794.0 (136.1)

59. Secondary Outcome

Title	OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	204	98
Day 169 cohort (n=204, n=98): PCS	27.52 (6.65)	28.07 (6.86)
Day 365 cohort (n=198, n=96): PCS	27.70 (6.76)	27.92 (6.83)
Day 729 cohort (n=155, n=73): PCS	27.81 (6.69)	28.65 (6.80)
Day 1093 cohort (n=130, n=58): PCS	27.92 (6.86)	28.25 (6.72)
Day 1457 cohort (n=114, n=50): PCS	28.31 (6.85)	28.06 (6.85)
Day 1821 cohort (n=103, n=47): PCS	28.48 (6.72)	28.27 (6.97)
Day 169 cohort (n=204, n=98): MCS	41.75 (12.53)	43.62 (12.12)
Day 365 cohort (n=198, n=96): MCS	41.54 (12.69)	43.96 (11.98)
Day 729 cohort (n=155, n=73): MCS	42.23 (12.86)	42.42 (11.89)
Day 1093 cohort (n=130, n=58): MCS	43.29 (12.25)	42.13 (11.75)
Day 1457 cohort (n=114, n=50): MCS	43.38 (12.20)	41.95 (11.67)
Day 1821 cohort (n=103, n=47): MCS	41.74 (12.82)	42.70 (11.64)

60. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	204	98
Day 169 cohort (n=204, n=98): PCS	7.46 (0.69)	1.90 (0.77)
Day 365 cohort (n=198, n=96): PCS	8.30 (0.74)	6.21 (0.94)
Day 729 cohort (n=155, n=73): PCS	10.28 (0.78)	6.79 (1.16)
Day 1093 cohort (n=130, n=58): PCS	10.30 (0.90)	8.61 (1.34)
Day 1457 cohort (n=114, n=50): PCS	8.71 (0.93)	8.51 (1.39)
Day 1821 cohort (n=103, n=47): PCS	9.32 (1.06)	9.35 (1.52)
Day 169 cohort (n=204, n=98): MCS	5.83 (0.83)	2.16 (0.91)
Day 365 cohort (n=198, n=96): MCS	5.18 (0.79)	5.32 (1.07)
Day 729 cohort (n=155, n=73): MCS	6.08 (0.92)	8.61 (1.42)
Day 1093 cohort (n=130, n=58): MCS	5.68 (1.05)	9.14 (1.72)
Day 1457 cohort (n=114, n=50): MCS	5.41 (1.12)	7.93 (1.77)
Day 1821 cohort (n=103, n=47): MCS	6.42 (1.24)	10.37 (1.75)

61. Secondary Outcome

Title	OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=208, n=98): Physical Function	26.22 (8.75)	26.60 (8.65)
Day 365 cohort (n=200, n=96): Physical Function	26.37 (8.88)	26.49 (8.62)
Day 729 cohort (n=156, n=74): Physical Function	27.03 (9.03)	26.66 (8.37)
Day 1093 cohort (n=133, n=59): Physical Function	27.06 (9.03)	25.66 (7.99)
Day 1457 cohort (n=118, n=50): Physical Function	27.54 (9.15)	25.41 (8.08)
Day 1821 cohort (n=104, n=47): Physical Function	27.86 (9.65)	25.61 (8.45)

62. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=208, n=98): Physical Function	5.75 (0.74)	1.82 (0.84)
Day 365 cohort (n=200, n=96): Physical Function	7.14 (0.79)	4.80 (0.97)
Day 729 cohort (n=156, n=74): Physical Function	7.61 (0.90)	7.38 (1.09)
Day 1093 cohort (n=133, n=59): Physical Function	8.24 (1.00)	9.68 (1.26)
Day 1457 cohort (n=118, n=50): Physical Function	6.36 (1.06)	8.98 (1.32)
Day 1821 cohort (n=104, n=47): Physical Function	7.34 (1.21)	8.57 (1.63)

63. Secondary Outcome

Title	OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=210, n=98): Role-Physical	30.50 (6.20)	32.36 (7.36)
Day 365 cohort (n=203, n=97): Role-Physical	30.49 (6.24)	32.40 (7.38)
Day 729 cohort (n=156, n=74): Role-Physical	30.48 (6.02)	32.45 (7.08)
Day 1093 cohort (n=135, n=59): Role-Physical	30.71 (6.42)	31.91 (6.98)
Day 1457 cohort (n=117, n=50): Role-Physical	31.20 (6.81)	31.91 (7.02)
Day 1821 cohort (n=106, n=47): Role-Physical	30.93 (6.63)	32.47 (7.58)

64. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=210, n=98): Role-Physical	7.82 (0.80)	1.30 (0.99)
Day 365 cohort (n=203, n=97): Role-Physical	7.78 (0.85)	6.49 (1.25)
Day 729 cohort (n=156, n=74): Role-Physical	10.76 (0.97)	6.59 (1.42)
Day 1093 cohort (n=135, n=59): Role-Physical	10.27 (1.10)	8.91 (1.58)
Day 1457 cohort (n=117, n=50): Role-Physical	9.09 (1.11)	7.64 (1.75)
Day 1821 cohort (n=106, n=47): Role-Physical	9.05 (1.28)	9.93 (1.87)

65. Secondary Outcome

Title	OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=209, n=98): Bodily Pain	30.76 (6.77)	31.90 (6.55)
Day 365 cohort (n=202, n=97): Bodily Pain	30.75 (6.80)	31.84 (6.56)
Day 729 cohort (n=156, n=74): Bodily Pain	31.00 (6.77)	31.98 (6.65)
Day 1093 cohort (n=135, n=59): Bodily Pain	31.41 (6.86)	31.71 (6.32)
Day 1457 cohort (n=117, n=50): Bodily Pain	31.73 (6.85)	31.38 (6.31)
Day 1821 cohort (n=106, n=47): Bodily Pain	31.60 (7.07)	31.78 (6.67)

66. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=209, n=98): Bodily Pain	9.59 (0.72)	3.32 (0.78)
Day 365 cohort (n=202, n=97): Bodily Pain	10.25 (0.73)	9.55 (0.98)
Day 729 cohort (n=156, n=74): Bodily Pain	12.36 (0.80)	10.29 (1.23)
Day 1093 cohort (n=135, n=59): Bodily Pain	12.33 (0.95)	11.34 (1.45)
Day 1457 cohort (n=117, n=50): Bodily Pain	10.79 (0.91)	11.52 (1.60)
Day 1821 cohort (n=106, n=47): Bodily Pain	11.83 (1.13)	14.33 (1.43)

67. Secondary Outcome

Title	OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=212, n=98): General Health	35.28 (9.49)	35.52 (8.76)
Day 365 cohort (n=204, n=97): General Health	35.50 (9.55)	35.48 (8.76)
Day 729 cohort (n=157, n=74): General Health	35.49 (9.79)	35.48 (8.98)
Day 1093 cohort (n=136, n=59): General Health	36.21 (9.79)	35.78 (8.79)
Day 1457 cohort (n=119, n=50): General Health	36.21 (9.99)	35.92 (8.92)
Day 1821 cohort (n=106, n=47): General Health	35.50 (10.1)	36.14 (9.02)

68. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=212, n=98): General Health	4.48 (0.59)	1.09 (0.82)
Day 365 cohort (n=204, n=97): General Health	4.36 (0.60)	4.04 (0.84)
Day 729 cohort (n=157, n=74): General Health	6.43 (0.67)	5.85 (0.98)
Day 1093 cohort (n=136, n=59): General Health	6.05 (0.71)	5.92 (1.35)
Day 1457 cohort (n=119, n=50): General Health	5.29 (0.82)	5.60 (1.41)
Day 1821 cohort (n=106, n=47): General Health	5.75 (0.81)	6.92 (1.46)

69. Secondary Outcome

Title	OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=212, n=98): Vitality	35.06 (8.82)	36.51 (9.15)
Day 365 cohort (n=204, n=97): Vitality	35.09 (8.73)	36.65 (9.09)
Day 729 cohort (n=157, n=74): Vitality	35.45 (9.00)	36.50 (8.95)
Day 1093 cohort (n=136, n=59): Vitality	35.74 (9.06)	36.53 (8.23)
Day 1457 cohort (n=118, n=50): Vitality	35.94 (8.99)	35.83 (8.18)
Day 1821 cohort (n=105, n=47): Vitality	35.01 (8.54)	36.35 (8.47)

70. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=212, n=98): Vitality	7.80 (0.75)	2.89 (0.87)
Day 365 cohort (n=204, n=97): Vitality	8.00 (0.76)	6.69 (0.98)
Day 729 cohort (n=157, n=74): Vitality	8.49 (0.83)	7.52 (1.20)
Day 1093 cohort (n=136, n=59): Vitality	8.23 (0.96)	8.61 (1.63)
Day 1457 cohort (n=118, n=50): Vitality	7.62 (0.96)	8.08 (1.76)
Day 1821 cohort (n=105, n=47): Vitality	8.51 (1.05)	9.82 (1.69)

71. Secondary Outcome

Title	OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=211, n=98): Social Functioning	33.31 (11.01)	34.37 (11.42)
Day 365 cohort (n=204, n=97): Social Functioning	33.59 (11.01)	34.30 (11.46)
Day 729 cohort (n=157, n=74): Social Functioning	33.87 (11.22)	34.32 (11.29)
Day 1093 cohort (n=136, n=59): Social Functioning	34.43 (10.86)	34.14 (11.46)
Day 1457 cohort (n=119, n=50): Social Functioning	35.20 (11.12)	33.36 (11.60)
Day 1821 cohort (n=106, n=47): Social Functioning	34.91 (11.62)	34.15 (11.88)

72. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=211, n=98): Social Functioning	8.36 (0.85)	2.99 (1.12)
Day 365 cohort (n=204, n=97): Social Functioning	8.17 (0.85)	7.22 (1.28)
Day 729 cohort (n=157, n=74): Social Functioning	9.89 (0.96)	9.10 (1.48)
Day 1093 cohort (n=136, n=59): Social Functioning	10.46 (1.05)	10.49 (1.54)
Day 1457 cohort (n=119, n=50): Social Functioning	8.62 (1.08)	11.83 (1.92)
Day 1821 cohort (n=106, n=47): Social Functioning	9.17 (1.16)	12.24 (1.79)

73. Secondary Outcome

Title	OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=210, n=98): Role-Emotional	35.73 (13.69)	37.60 (14.00)
Day 365 cohort (n=203, n=97): Role-Emotional	35.93 (13.73)	37.75 (14.00)
Day 729 cohort (n=156, n=73): Role-Emotional	36.09 (13.65)	35.86 (13.45)
Day 1093 cohort (n=134, n=58): Role-Emotional	36.87 (13.82)	35.54 (13.54)
Day 1457 cohort (n=117, n=50): Role-Emotional	37.06 (13.58)	36.17 (13.74)
Day 1821 cohort (n=106, n=47): Role-Emotional	36.26 (13.80)	36.29 (13.65)

74. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=210, n=98): Role-Emotional	7.17 (1.11)	1.83 (1.40)
Day 365 cohort (n=203, n=97): Role-Emotional	5.47 (1.04)	6.52 (1.58)
Day 729 cohort (n=156, n=73): Role-Emotional	7.29 (1.18)	10.39 (1.94)
Day 1093 cohort (n=134, n=58): Role-Emotional	6.88 (1.36)	11.62 (2.28)
Day 1457 cohort (n=117, n=50): Role-Emotional	6.66 (1.49)	6.32 (2.39)
Day 1821 cohort (n=106, n=47): Role-Emotional	7.26 (1.55)	12.10 (2.35)

75. Secondary Outcome

Title	OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=212, n=98): Mental Health	40.96 (13.07)	43.47 (11.34)
Day 365 cohort (n=204, n=97): Mental Health	41.11 (13.06)	43.53 (11.37)
Day 729 cohort (n=157, n=73): Mental Health	41.85 (13.38)	42.69 (10.81)
Day 1093 cohort (n=136, n=59): Mental Health	42.68 (12.58)	41.85 (10.54)
Day 1457 cohort (n=118, n=50): Mental Health	42.52 (12.74)	41.44 (10.62)
Day 1821 cohort (n=105, n=47): Mental Health	41.36 (13.05)	42.50 (10.36)

76. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL
Description	SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=212, n=98): Mental Health	4.42 (0.71)	1.65 (0.83)
Day 365 cohort (n=204, n=97): Mental Health	4.53 (0.73)	4.29 (0.93)
Day 729 cohort (n=157, n=73): Mental Health .	5.54 (0.84)	7.19 (1.29)
Day 1093 cohort (n=136, n=59): Mental Health	5.24 (0.95)	7.69 (1.45)
Day 1457 cohort (n=118, n=50): Mental Health	4.60 (0.89)	8.91 (1.41)
Day 1821 cohort (n=105, n=47): Mental Health	5.31 (1.08)	8.66 (1.53)

77. Secondary Outcome

Title	OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL
Description	The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem 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 a higher score reflecting more severe problems with sleep. The mean score of the SPI in a population with chronic problems is 29.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=212, n=98)	49.18 (18.10)	45.49 (17.72)
Day 365 cohort (n=204, n=97)	48.87 (19.09)	45.54 (17.86)
Day 729 cohort (n=157, n=74)	48.62 (18.12)	45.36 (17.26)
Day 1093 cohort (n=136, n=59)	48.01 (17.86)	46.44 (17.28)
Day 1457 cohort (n=119, n=50)	46.71 (17.97)	47.14 (18.47)
Day 1821 cohort (n=106, n=47)	47.49 (17.27)	45.09 (17.90)

78. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL
Description	The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem 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 a higher score reflecting more severe problems with sleep. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	208	98
Day 169 cohort (n=212, n=98)	-11.1 (1.10)	-4.31 (1.59)
Day 365 cohort (n=204, n=97)	-11.2 (1.33)	-10.4 (1.82)
Day 729 cohort (n=157, n=74)	-12.5 (1.38)	-11.9 (2.06)
Day 1093 cohort (n=136, n=59)	-12.9 (1.47)	-16.1 (2.53)
Day 1457 cohort (n=119, n=50)	-9.86 (1.56)	-11.9 (2.92)
Day 1821 cohort (n=106, n=47)	-11.7 (1.55)	-15.9 (2.84)

79. Secondary Outcome

Title	OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL
Description	Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	212	98
Day 169 cohort (n=212, n=98)	73.73 (19.84)	71.24 (20.27)
Day 365 cohort (n=204, n=97)	73.54 (20.00)	70.78 (20.13)
Day 729 cohort (n=157, n=74)	73.75 (19.18)	69.59 (20.74)
Day 1093 cohort (n=135, n=59)	73.21 (19.93)	70.00 (21.00)
Day 1457 cohort (n=119, n=50)	72.15 (19.73)	71.14 (19.57)
Day 1821 cohort (n=106, n=47)	72.36 (20.51)	69.68 (20.08)

80. Secondary Outcome

Title	OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL
Description	Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.
Time Frame	BL, Days 169, 365, 729, 1093, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	212	98
Day 169 cohort (n=212, n=98)	-25.0 (1.95)	-7.28 (2.86)
Day 365 cohort (n=204, n=97)	-26.1 (2.10)	-21.8 (2.77)
Day 729 cohort (n=157, n=74)	-28.2 (2.08)	-22.2 (3.71)
Day 1093 cohort (n=135, n=59)	-28.4 (2.53)	-24.6 (4.58)
Day 1457 cohort (n=119, n=50)	-26.9 (2.52)	-25.8 (4.60)
Day 1821 cohort (n=106, n=47)	-26.8 (3.03)	-28.5 (4.71)

81. Secondary Outcome

Title	OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL
Description	Limitations on activities of daily living in the OL period at each study visit were measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.
Time Frame	BL

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	206	94
Day 169 cohort (n=206, n=94)	17.18 (11.09)	15.01 (11.34)
Day 365 cohort (n=196, n=93)	16.97 (11.17)	15.70 (11.29)
Day 729 cohort (n=150, n=72)	16.59 (11.40)	14.56 (10.87)
Day 1093 cohort (n=128, n=56)	15.66 (11.26)	15.38 (10.94)

82. Secondary Outcome

Title	OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL
Description	Limitations on activities of daily living in the OL period at each study visit was measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.
Time Frame	Days 169, 365, 729, 1093, 1457, and 1821

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Arm/Group Title	OL: ABA	OL: PLA
Arm/Group Description	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.	Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Measure Participants	206	94
Day 169 cohort (n=206, n=94)	-7.80 (0.83)	-1.78 (1.01)
Day 365 cohort (n=196, n=93)	-8.04 (0.91)	-6.08 (0.98)
Day 729 cohort (n=150, n=72)	-8.29 (1.00)	-8.32 (1.25)
Day 1093 cohort (n=128, n=56)	-8.98 (1.09)	-8.88 (1.51)

83. Secondary Outcome

Title	Cumulative Analysis (DB + OL); Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbent Assay (ELISA)
Description	Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Time Frame	From BL (Day 1) to Day 1821

Outcome Measure Data

Analysis Population Description

All participants treated on study with at least one post-baseline immunogenicity measurement.

Arm/Group Title	All Treated Participants
Arm/Group Description	Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive either abatacept or placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 of abatacept. Abatacept or placebo was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
Measure Participants	329
Anti-abatacept antibodies	22 8.5%
Anti-CTLA4 antibodies	5 1.9%
Total	26 10.1%

Adverse Events

Arm/Group Title	Open-label ABA		Abatacept (ABA)		Placebo (PLA)
Arm/Group Description	All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.		Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. 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 7 doses. Each dose was infused intravenously over approximately 30 minutes.		Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
All Cause Mortality
	Open-label ABA		Abatacept (ABA)		Placebo (PLA)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Open-label ABA		Abatacept (ABA)		Placebo (PLA)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	136/317 (42.9%)		28/258 (10.9%)		16/133 (12%)
Blood and lymphatic system disorders
ANAEMIA	2/317 (0.6%)		0/258 (0%)		0/133 (0%)
LEUKOCYTOSIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
Cardiac disorders
PERICARDITIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ANGINA PECTORIS	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
CARDIAC TAMPONADE	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
ATRIAL FIBRILLATION	0/317 (0%)		1/258 (0.4%)		1/133 (0.8%)
SICK SINUS SYNDROME	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
MYOCARDIAL INFARCTION	3/317 (0.9%)		1/258 (0.4%)		0/133 (0%)
PERICARDIAL HAEMORRHAGE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
CARDIAC FAILURE CONGESTIVE	2/317 (0.6%)		2/258 (0.8%)		1/133 (0.8%)
ACUTE MYOCARDIAL INFARCTION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
SUPRAVENTRICULAR TACHYCARDIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ATRIOVENTRICULAR BLOCK COMPLETE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
Congenital, familial and genetic disorders
URETHRAL INTRINSIC SPHINCTER DEFICIENCY	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
Gastrointestinal disorders
NAUSEA	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
VOMITING	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
DIARRHOEA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
DYSPHAGIA	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
JEJUNITIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
PERITONITIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
DIVERTICULUM	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
PANCREATITIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
GASTRIC ULCER	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
ABDOMINAL PAIN	1/317 (0.3%)		1/258 (0.4%)		0/133 (0%)
UMBILICAL HERNIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
COLITIS ISCHAEMIC	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
HERNIAL EVENTRATION	2/317 (0.6%)		0/258 (0%)		0/133 (0%)
OBSTRUCTION GASTRIC	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ABDOMINAL DISCOMFORT	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ABDOMINAL PAIN UPPER	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
DIARRHOEA HAEMORRHAGIC	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
INTESTINAL OBSTRUCTION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
INTESTINAL PERFORATION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
RETROPERITONEAL HAEMORRHAGE	1/317 (0.3%)		0/258 (0%)		1/133 (0.8%)
SMALL INTESTINAL OBSTRUCTION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
General disorders
PAIN	0/317 (0%)		0/258 (0%)		2/133 (1.5%)
DEATH	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
PYREXIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ASTHENIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
CHEST PAIN	6/317 (1.9%)		0/258 (0%)		1/133 (0.8%)
IMPAIRED HEALING	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
OEDEMA PERIPHERAL	2/317 (0.6%)		0/258 (0%)		0/133 (0%)
ADVERSE DRUG REACTION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
CATHETER SITE HAEMORRHAGE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
MECHANICAL COMPLICATION OF IMPLANT	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
Hepatobiliary disorders
LIVER INJURY	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
CHOLECYSTITIS	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
CHOLELITHIASIS	5/317 (1.6%)		1/258 (0.4%)		0/133 (0%)
CYTOLYTIC HEPATITIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
AUTOIMMUNE HEPATITIS	2/317 (0.6%)		0/258 (0%)		0/133 (0%)
Immune system disorders
AMYLOIDOSIS	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
Infections and infestations
SEPSIS	2/317 (0.6%)		0/258 (0%)		1/133 (0.8%)
PNEUMONIA	10/317 (3.2%)		1/258 (0.4%)		0/133 (0%)
PYOTHORAX	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
CELLULITIS	2/317 (0.6%)		0/258 (0%)		0/133 (0%)
BACTERAEMIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
PHARYNGITIS	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
OSTEOMYELITIS	1/317 (0.3%)		0/258 (0%)		1/133 (0.8%)
DIVERTICULITIS	1/317 (0.3%)		1/258 (0.4%)		0/133 (0%)
PYELONEPHRITIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
RECTAL ABSCESS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ACUTE SINUSITIS	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
GASTROENTERITIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
GRAFT INFECTION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
LOBAR PNEUMONIA	5/317 (1.6%)		0/258 (0%)		0/133 (0%)
BRONCHOPNEUMONIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ORAL CANDIDIASIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
BURSITIS INFECTIVE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
KERATITIS HERPETIC	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
INFECTED SKIN ULCER	1/317 (0.3%)		1/258 (0.4%)		0/133 (0%)
PNEUMONIA BACTERIAL	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
PNEUMONIA INFLUENZAL	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
PYELONEPHRITIS ACUTE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
STREPTOCOCCAL SEPSIS	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
GASTROENTERITIS VIRAL	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
SUBACUTE ENDOCARDITIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ENDOCARDITIS BACTERIAL	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ENTEROBACTER PNEUMONIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
PERIORBITAL CELLULITIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
STAPHYLOCOCCAL ABSCESS	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
URINARY TRACT INFECTION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
DEVICE RELATED INFECTION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
PERIDIVERTICULAR ABSCESS	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
WOUND INFECTION STAPHYLOCOCCAL	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
LOWER RESPIRATORY TRACT INFECTION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
Injury, poisoning and procedural complications
FALL	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
WOUND	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
CORNEAL SCAR	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
HIP FRACTURE	6/317 (1.9%)		0/258 (0%)		1/133 (0.8%)
JOINT INJURY	2/317 (0.6%)		0/258 (0%)		0/133 (0%)
ANKLE FRACTURE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
FEMUR FRACTURE	2/317 (0.6%)		0/258 (0%)		0/133 (0%)
MENISCUS LESION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
HUMERUS FRACTURE	3/317 (0.9%)		0/258 (0%)		0/133 (0%)
JOINT DISLOCATION	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
DEVICE DISLOCATION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
FAILURE OF IMPLANT	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
UPPER LIMB FRACTURE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
FEMORAL NECK FRACTURE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
DISLOCATION OF VERTEBRA	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
CERVICAL VERTEBRAL FRACTURE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
MEDICAL DEVICE COMPLICATION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
Investigations
WEIGHT DECREASED	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
BLOOD GLUCOSE DECREASED	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ELECTROCARDIOGRAM CHANGE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
RED BLOOD CELL SEDIMENTATION RATE INCREASED	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
Metabolism and nutrition disorders
OBESITY	3/317 (0.9%)		0/258 (0%)		0/133 (0%)
DEHYDRATION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
HYPOKALAEMIA	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
HYPERKALAEMIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ELECTROLYTE IMBALANCE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
Musculoskeletal and connective tissue disorders
BURSITIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ARTHRITIS	4/317 (1.3%)		0/258 (0%)		0/133 (0%)
BACK PAIN	4/317 (1.3%)		0/258 (0%)		1/133 (0.8%)
SYNOVITIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ARTHRALGIA	2/317 (0.6%)		0/258 (0%)		0/133 (0%)
OSTEONECROSIS	2/317 (0.6%)		0/258 (0%)		0/133 (0%)
OSTEOARTHRITIS	13/317 (4.1%)		2/258 (0.8%)		1/133 (0.8%)
FRACTURE NONUNION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
MUSCULAR WEAKNESS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
RHEUMATOID NODULE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
RHEUMATOID ARTHRITIS	42/317 (13.2%)		5/258 (1.9%)		3/133 (2.3%)
ROTATOR CUFF SYNDROME	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
LUMBAR SPINAL STENOSIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
SPINAL COLUMN STENOSIS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
INTERVERTEBRAL DISC DISORDER	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
INTERVERTEBRAL DISC PROTRUSION	1/317 (0.3%)		0/258 (0%)		1/133 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
LEIOMYOMA	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
SKIN CANCER	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
COLON CANCER	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
BREAST CANCER	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
LUNG NEOPLASM	2/317 (0.6%)		0/258 (0%)		0/133 (0%)
GASTRIC CANCER	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
UTERINE CANCER	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
PROSTATE CANCER	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
T-CELL LYMPHOMA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ACOUSTIC NEUROMA	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
THYROID NEOPLASM	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
METASTATIC NEOPLASM	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
BASAL CELL CARCINOMA	4/317 (1.3%)		1/258 (0.4%)		0/133 (0%)
HEAD AND NECK CANCER	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
SQUAMOUS CELL CARCINOMA	3/317 (0.9%)		0/258 (0%)		0/133 (0%)
OVARIAN EPITHELIAL CANCER	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
PARATHYROID TUMOUR BENIGN	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
THYROID CANCER METASTATIC	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
SQUAMOUS CELL CARCINOMA OF SKIN	3/317 (0.9%)		0/258 (0%)		0/133 (0%)
Nervous system disorders
SYNCOPE	2/317 (0.6%)		0/258 (0%)		0/133 (0%)
DEMENTIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
HEADACHE	2/317 (0.6%)		0/258 (0%)		0/133 (0%)
SCIATICA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
CONVULSION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
HYPOAESTHESIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
RADICULOPATHY	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ISCHAEMIC STROKE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
NERVE COMPRESSION	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
CEREBRAL ISCHAEMIA	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
CEREBRAL INFARCTION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
CERVICAL MYELOPATHY	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
LOSS OF CONSCIOUSNESS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
CEREBROVASCULAR ACCIDENT	1/317 (0.3%)		1/258 (0.4%)		0/133 (0%)
Renal and urinary disorders
RENAL COLIC	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
RENAL FAILURE	1/317 (0.3%)		0/258 (0%)		1/133 (0.8%)
NEPHROLITHIASIS	3/317 (0.9%)		0/258 (0%)		0/133 (0%)
RENAL IMPAIRMENT	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
CALCULUS URETHRAL	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
RENAL FAILURE ACUTE	1/317 (0.3%)		1/258 (0.4%)		0/133 (0%)
Reproductive system and breast disorders
CYSTOCELE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
MENORRHAGIA	1/317 (0.3%)		1/258 (0.4%)		0/133 (0%)
METRORRHAGIA	0/317 (0%)		1/258 (0.4%)		0/133 (0%)
OVARIAN CYST	2/317 (0.6%)		0/258 (0%)		1/133 (0.8%)
ENDOMETRIOSIS	1/317 (0.3%)		0/258 (0%)		1/133 (0.8%)
UTERINE POLYP	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
BREAST ATROPHY	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
MENOMETRORRHAGIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ADNEXA UTERI MASS	0/317 (0%)		0/258 (0%)		1/133 (0.8%)
FEMALE GENITAL TRACT FISTULA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
Respiratory, thoracic and mediastinal disorders
ASTHMA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ASPHYXIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
DYSPNOEA	1/317 (0.3%)		0/258 (0%)		1/133 (0.8%)
PLEURISY	2/317 (0.6%)		0/258 (0%)		0/133 (0%)
EMPHYSEMA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
SINUS POLYP	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
PULMONARY EMBOLISM	1/317 (0.3%)		1/258 (0.4%)		0/133 (0%)
RESPIRATORY FAILURE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
PULMONARY CAVITATION	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
RESPIRATORY DISTRESS	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
INTERSTITIAL LUNG DISEASE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
Skin and subcutaneous tissue disorders
DECUBITUS ULCER	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
Vascular disorders
HAEMATOMA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
ISCHAEMIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
HAEMORRHAGE	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
HYPERTENSION	3/317 (0.9%)		1/258 (0.4%)		0/133 (0%)
PERIPHERAL EMBOLISM	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
DEEP VEIN THROMBOSIS	3/317 (0.9%)		0/258 (0%)		0/133 (0%)
PERIPHERAL ISCHAEMIA	1/317 (0.3%)		0/258 (0%)		0/133 (0%)
Other (Not Including Serious) Adverse Events
	Open-label ABA		Abatacept (ABA)		Placebo (PLA)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	276/317 (87.1%)		153/258 (59.3%)		65/133 (48.9%)
Blood and lymphatic system disorders
ANAEMIA	16/317 (5%)		3/258 (1.2%)		3/133 (2.3%)
Gastrointestinal disorders
NAUSEA	47/317 (14.8%)		17/258 (6.6%)		8/133 (6%)
VOMITING	23/317 (7.3%)		6/258 (2.3%)		3/133 (2.3%)
DIARRHOEA	49/317 (15.5%)		14/258 (5.4%)		8/133 (6%)
ABDOMINAL PAIN	17/317 (5.4%)		6/258 (2.3%)		1/133 (0.8%)
ABDOMINAL PAIN UPPER	20/317 (6.3%)		4/258 (1.6%)		2/133 (1.5%)
General disorders
FATIGUE	30/317 (9.5%)		8/258 (3.1%)		6/133 (4.5%)
PYREXIA	20/317 (6.3%)		6/258 (2.3%)		2/133 (1.5%)
CHEST PAIN	23/317 (7.3%)		2/258 (0.8%)		1/133 (0.8%)
OEDEMA PERIPHERAL	20/317 (6.3%)		5/258 (1.9%)		3/133 (2.3%)
Immune system disorders
SEASONAL ALLERGY	18/317 (5.7%)		1/258 (0.4%)		0/133 (0%)
Infections and infestations
INFLUENZA	32/317 (10.1%)		6/258 (2.3%)		3/133 (2.3%)
SINUSITIS	59/317 (18.6%)		15/258 (5.8%)		5/133 (3.8%)
BRONCHITIS	66/317 (20.8%)		15/258 (5.8%)		6/133 (4.5%)
HERPES ZOSTER	18/317 (5.7%)		4/258 (1.6%)		3/133 (2.3%)
TOOTH ABSCESS	18/317 (5.7%)		1/258 (0.4%)		1/133 (0.8%)
GASTROENTERITIS	22/317 (6.9%)		2/258 (0.8%)		1/133 (0.8%)
NASOPHARYNGITIS	61/317 (19.2%)		20/258 (7.8%)		8/133 (6%)
URINARY TRACT INFECTION	56/317 (17.7%)		7/258 (2.7%)		7/133 (5.3%)
UPPER RESPIRATORY TRACT INFECTION	105/317 (33.1%)		15/258 (5.8%)		10/133 (7.5%)
Injury, poisoning and procedural complications
FALL	23/317 (7.3%)		9/258 (3.5%)		7/133 (5.3%)
CONTUSION	17/317 (5.4%)		8/258 (3.1%)		1/133 (0.8%)
Musculoskeletal and connective tissue disorders
BURSITIS	19/317 (6%)		1/258 (0.4%)		0/133 (0%)
BACK PAIN	54/317 (17%)		15/258 (5.8%)		6/133 (4.5%)
Nervous system disorders
HEADACHE	51/317 (16.1%)		32/258 (12.4%)		7/133 (5.3%)
DIZZINESS	33/317 (10.4%)		11/258 (4.3%)		5/133 (3.8%)
Psychiatric disorders
INSOMNIA	21/317 (6.6%)		7/258 (2.7%)		3/133 (2.3%)
DEPRESSION	24/317 (7.6%)		6/258 (2.3%)		3/133 (2.3%)
Respiratory, thoracic and mediastinal disorders
COUGH	43/317 (13.6%)		12/258 (4.7%)		4/133 (3%)
DYSPNOEA	16/317 (5%)		7/258 (2.7%)		1/133 (0.8%)
Skin and subcutaneous tissue disorders
RASH	31/317 (9.8%)		6/258 (2.3%)		3/133 (2.3%)
Vascular disorders
HYPERTENSION	43/317 (13.6%)		10/258 (3.9%)		4/133 (3%)

Limitations/Caveats

[Not Specified]

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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.