A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00484289
Collaborator
(none)
217
39
3
48
5.6
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to demonstrate the safety of chronic use of abatacept in Japanese Subjects with Rheumatoid Arthritis (RA) having completed clinical studies IM101-071, IM101-034, and also Disease Modifying Anti-Rheumatic Drugs (DMARDs) failures with MTX intolerance.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
217 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multi-center, Open-label, Uncontrolled, Long-term Study to Evaluate the Safety of Abatacept (BMS-188667) in Japanese Subjects With Rheumatoid Arthritis Having Completed Clinical Studies IM101-071, IM101-034, and Also Special DMARD Failures
Study Start Date
:
Dec 1, 2006
Actual Primary Completion Date
:
Dec 1, 2010
Actual Study Completion Date
:
Dec 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1: Participants from Phase I study (IM101-034)
|
Drug: Abatacept
Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants > 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
Other Names:
|
| Experimental: Arm 2: Participants from Phase II study (IM101-071)
|
Drug: Abatacept
Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants > 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
Other Names:
|
| Experimental: Arm 3: New Participants with Methotrexate (MTX) Intolerance
|
Drug: Abatacept
Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants > 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs [From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).]
AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is 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 cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included.
- Number of Participants With Abnormal Laboratory Changes (ALC) [From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).]
The laboratory tests were analyses included enzyme, gastrointestinal, hematology, hepatobiliary, lipid, metabolic, nutritional, blood gas, microbiology, serology, protein, chemistry, renal, urinary tract, urinalyses, water, electrolyte and mineral investigations.
- Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator [At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).]
Secondary Outcome Measures
- Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time [At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.]
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 activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.
- Percentage of Participants With ACR 50 Response Over Time [At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.]
ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.
- Percentage of Participants With ACR 70 Response Over Time [At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.]
ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.
- Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) [At BL (week 0), week 24, 48, 96, 144, and 192.]
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (change of > 5.1), low disease activity (change of ≤ 3.2) and remission (< 2.6). Please see outcome 8 for change from BL data.
- Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 [At BL (week 0), weeks 24, 48, 96, 144, and 192.]
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Please refer to outcome 7 for BL and PBL values.
- Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 [At BL (week 0), weeks 24, 48, 96, 144, and 192.]
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score change ≥ 1.2 from BL were considered to have improvement.
- Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 [At weeks 24, 48, 96, 144, and 192.]
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score ≤ 3.2 were considered to have low disease activity.
- Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 [At weeks 24, 48, 96, 144, and 192.]
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score < 2.6 were considered to be in remission.
- Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 [At BL (week 0), weeks 24, 48, 96, 144, and 192.]
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 BL in HAQ.
- Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores [At BL (week 0), weeks 24, 48, 96, 144, and 192.]
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 14 for change from BL data.
- Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 [At baseline (week 0), weeks 24, 48, 96, 144, and 192.]
The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful. Please see outcome 13 for BL and PBL values.
- Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores [At BL (week 0), weeks 24, 48, 96, 144, and 192.]
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Please see outcome 14 for change from BL data.
- Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 [At BL (Week 0), weeks 24, 48, 96, 144, and 192.]
The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 15 for BL and PBL values.
- Baseline and Postbaseline C-reactive Protein (CRP) Levels [At BL (week 0), weeks 24, 48, 96, 144, and 192.]
CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Please see outcome 18 for change from BL data.
- Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 [At BL (week 0), weeks 24, 48, 96, 144, and 192.]
CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease, negative values indicate improvement. Percentage improvement from BL = (BL - PBL value) / BL value * 100. Please refer to outcome 17 for BL and PBL values.
- Baseline and Postbaseline Rheumatoid Factor Levels [At BL (week 0), weeks 24, 48, 96, 144, and 192.]
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. RF levels are considered positive if value is >20 and considered negative if value is <20. Please see outcome 20 for change from BL data.
- Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 [At BL (week 0), weeks 24, 48, 96, 144, and 192.]
RF 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. RF levels are considered positive if value is >20 and considered negative if value is <20. Please refer to outcome 19 for BL and PBL values.
- Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies [At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192.]
Validated enzyme-linked immunoassay (ELISA) method was used to measure anti-abatacept and anti-CTLA4-T antibody levels. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed.
- Abatacept PK Parameter: Total Body Clearance [Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.]
Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism.
- Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State [Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.]
Area under the plasma concentration-time curve (AUCss) at steady state for each dosing interval was determined using the linear trapezoidal rule.
- Abatacept PK Parameter: Maximum Serum Concentration at Steady State [Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.]
Maximum plasma concentration is the maximum observed serum drug concentration at steady state (Css max).
- Abatacept PK Parameter: Minimum Plasma Concentration at Steady State [Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.]
Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration at steady state.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria
-
The participants who completed the 169 days, full study period of Phase II (IM101-071) and were not administered other biologics between completion of IM101-071 and registration of this long-term study.
-
The participants of the Phase I study (IM101-034), who received abatacept, except participants who were withdrawn from the study due to safety problems related to abatacept.
-
New subjects with MTX intolerance: rheumatoid arthritis (RA) patients to whom MTX cannot be administered for safety reasons and who present an inadequate response to disease-modifying antirheumatic drugs (DMARDs;excluding MTX) or biologics (new subjects with MTX intolerance: RA patients who present an inadequate response to DMARDs).
Exclusion Criteria
-
Women of childbearing potential (WOCBP) who were unwilling or unable to use an acceptable method of contraception.
-
Participants who have received non approved or investigational biologics (other than abatacept from previous or ongoing studies in Japan) at registration.
-
Participants who have received treatment with any investigational drug within 56 days before registration or five half-lives (whichever is the longest).
-
Participants currently receiving treatment with leflunomide, mycophenolate mofetil, calcineurine inhibitors such as cyclosporine and tacrolimus, D-Penicillamine, Cyclophosphamide, or immunoadsorption columns.
-
The participants who completed Phase II (IM101-071) are not applicable in the following instances at time of registration: with active vasculitis, symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, breast cancer, or a history of cancer within the last 5 years, evidence of active or latent bacterial , viral infections, any serious or chronic, at risk of tuberculosis (TB), with any opportunistic infections, laboratory values of hemoglobin < 8.5 g/dL, white blood cells (WBC) < 3,000/mm3, Platelets < 100,000/mm3, Serum creatinine > 2 times upper limit of normal (ULN), Serum alanine transaminase or aspartate aminotransferase > 2 times ULN.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Nagoya-Shi | Aichi | Japan | 460-0001 |
| 2 | Local Institution | Nagoya | Aichi | Japan | 466-8550 |
| 3 | Local Institution | Goshogawara-Shi | Aomori | Japan | 037-0053 |
| 4 | Local Institution | Chiba-Shi | Chiba | Japan | |
| 5 | Local Institution | Fukui-Shi | Fukui | Japan | 910-0041 |
| 6 | Local Institution | Fukui-Shi | Fukui | Japan | 9100067 |
| 7 | Local Institution | Fukui-Shi | Fukui | Japan | 9103133 |
| 8 | Local Institution | Fukuoka-Shi | Fukuoka | Japan | 810-0065 |
| 9 | Local Institution | Fukuoka-Shi | Fukuoka | Japan | 812-0025 |
| 10 | Local Institution | Kitakyushu-Shi | Fukuoka | Japan | 807-8555 |
| 11 | Local Institution | Higashi-Hiroshima-Shi | Hiroshima | Japan | 739-0002 |
| 12 | Local Institution | Sapporo City | Hokkaido | Japan | 060-8648 |
| 13 | Local Institution | Sapporo-City | Hokkaido | Japan | 060-0001 |
| 14 | Local Institution | Sapporo-City | Hokkaido | Japan | 060-8604 |
| 15 | Local Institution | Kanzaki-Gun | Hyogo | Japan | 679-2414 |
| 16 | Local Institution | Kato-Gun | Hyogo | Japan | 673-1462 |
| 17 | Local Institution | Hitachi-Shi | Ibaraki | Japan | 316-0035 |
| 18 | Local Institution | Tsukuba-Shi | Ibaraki | Japan | 305-0005 |
| 19 | Local Institution | Sagamihara-Shi | Kanagawa | Japan | 228-8522 |
| 20 | Local Institution | Sendai-Shi | Miyagi | Japan | 981-0911 |
| 21 | Local Institution | Sendai-Shi | Miyagi | Japan | 982-0032 |
| 22 | Local Institution | Sendai | Miyagi | Japan | |
| 23 | Local Institution | Nagano-Shi | Nagano | Japan | 380-8582 |
| 24 | Local Institution | Tsukubo-Gun | Okayama | Japan | 701-0304 |
| 25 | Local Institution | Kawachinagano-Shi | Osaka | Japan | 86-0008 |
| 26 | Local Institution | Ureshino-Shi | Saga | Japan | 843-0301 |
| 27 | Local Institution | Iruma-Gun | Saitama | Japan | 350-0495 |
| 28 | Local Institution | Kawagoe-Shi | Saitama | Japan | 350-8550 |
| 29 | Local Institution | Kitamoto-Shi | Saitama | Japan | 364-0026 |
| 30 | Local Institution | Hamamatsu-Shi | Shizuoka | Japan | 430-0906 |
| 31 | Local Institution | Kawachigun | Tochigi | Japan | 329-1104 |
| 32 | Local Institution | Shimotsuke-Shi | Tochigi | Japan | 3290498 |
| 33 | Local Institution | Arakawa-Ku | Tokyo | Japan | 116-0011 |
| 34 | Local Institution | Bunkyo-Ku | Tokyo | Japan | 113-0022 |
| 35 | Local Institution | Bunkyo-Ku | Tokyo | Japan | 113-8519 |
| 36 | Local Institution | Setagaya-Ku | Tokyo | Japan | 155-0032 |
| 37 | Local Institution | Shinjuku-Ku | Tokyo | Japan | 162-0054 |
| 38 | Local Institution | Takaoka-Shi | Toyama | Japan | 933-8525 |
| 39 | Local Institution | Chiba-Shi | Japan | 260-0801 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00484289
Other Study ID Numbers:
- IM101-129
First Posted:
Jun 8, 2007
Last Update Posted:
Jun 24, 2013
Last Verified:
Jun 1, 2013
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Period Title: Long Term Phase | |||
| STARTED | 13 | 178 | 26 |
| COMPLETED | 10 | 142 | 10 |
| NOT COMPLETED | 3 | 36 | 16 |
| Period Title: Long Term Phase | |||
| STARTED | 10 | 142 | 10 |
| COMPLETED | 10 | 141 | 10 |
| NOT COMPLETED | 0 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Total of all reporting groups |
| Overall Participants | 13 | 178 | 26 | 217 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
52.8
(11.6)
|
53.2
(11.5)
|
57.8
(10.6)
|
53.8
(11.4)
|
| Age, Customized (participants) [Number] | ||||
| 20 - 29 years |
1
7.7%
|
7
3.9%
|
0
0%
|
8
3.7%
|
| 30 - 39 years |
2
15.4%
|
13
7.3%
|
1
3.8%
|
16
7.4%
|
| 40 - 49 years |
0
0%
|
39
21.9%
|
5
19.2%
|
44
20.3%
|
| 50 - 59 years |
6
46.2%
|
70
39.3%
|
7
26.9%
|
83
38.2%
|
| ≥ 60 years |
4
30.8%
|
49
27.5%
|
13
50%
|
66
30.4%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
12
92.3%
|
146
82%
|
19
73.1%
|
177
81.6%
|
| Male |
1
7.7%
|
32
18%
|
7
26.9%
|
40
18.4%
|
| Weight (kg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg] |
55.2
(9.7)
|
56.9
(9.4)
|
53.9
(10.8)
|
56.5
(9.6)
|
| Duration of Rheumatoid Arthritis (participants) [Number] | ||||
| <= 2 years |
0
(9.0)
0%
|
24
(7.3)
13.5%
|
2
(10.1)
7.7%
|
26
(7.9)
12%
|
| >2 to <= 5 years |
2
15.4%
|
45
25.3%
|
4
15.4%
|
51
23.5%
|
| > 5 to <= 10 years |
2
15.4%
|
57
32%
|
12
46.2%
|
71
32.7%
|
| > 10 years |
9
69.2%
|
52
29.2%
|
8
30.8%
|
69
31.8%
|
| American College of Rheumatology (ACR) Functional Status Classification (participants) [Number] | ||||
| Class I |
0
0%
|
29
16.3%
|
0
0%
|
29
13.4%
|
| Class II |
12
92.3%
|
112
62.9%
|
17
65.4%
|
141
65%
|
| Class III |
1
7.7%
|
37
20.8%
|
9
34.6%
|
47
21.7%
|
| Class IV |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Number of Tender Joints (joints) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [joints] |
8.4
(5.2)
|
14.3
(11.2)
|
22.7
(13.3)
|
14.9
(11.6)
|
| Number of Swollen Joints (joints) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [joints] |
9.1
(4.7)
|
11.6
(8.7)
|
17.2
(10.0)
|
12.1
(8.9)
|
| Participant Pain Assessment (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
43.1
(23.5)
|
52.3
(24.9)
|
80.6
(20.1)
|
55.1
(26.0)
|
| Physical Function (Health Assessment Questionnaire [HAQ]) (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
0.98
(0.57)
|
1.16
(0.75)
|
1.80
(0.90)
|
1.22
(0.79)
|
| Physician Global Assessment (Units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Units on a scale] |
56.5
(24.7)
|
47.5
(24.0)
|
75.5
(16.5)
|
51.4
(24.9)
|
| Participant Global Assessment (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
47.1
(20.7)
|
50.8
(23.8)
|
77.3
(20.4)
|
53.7
(24.8)
|
| C-Reactive Protein (CRP) Level (mg/dL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dL] |
1.84
(2.84)
|
2.32
(2.18)
|
4.67
(3.65)
|
2.57
(2.55)
|
| Morning stiffness (minutes) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [minutes] |
117.7
(201.3)
|
72.7
(124.9)
|
166.6
(195.7)
|
86.7
(143.0)
|
| Rheumatoid Factor Status (participants) [Number] | ||||
| Negative (<=20 IU/mL) |
1
7.7%
|
24
13.5%
|
4
15.4%
|
29
13.4%
|
| Positive (>20 IU/mL) |
12
92.3%
|
154
86.5%
|
22
84.6%
|
188
86.6%
|
| Methotrexate Usage at Registration (mg/week) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/week] |
7.11
(1.45)
|
7.11
(1.07)
|
NA
(NA)
|
7.11
(1.09)
|
| Oral Corticosteroids Usage at Registration (mg/day) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/day] |
6.15
(2.37)
|
5.67
(2.38)
|
6.78
(2.48)
|
5.85
(2.41)
|
Outcome Measures
| Title | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs |
|---|---|
| Description | AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is 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 cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included. |
| Time Frame | From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months). |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| SAEs |
4
30.8%
|
50
28.1%
|
14
53.8%
|
| Drug-related SAEs |
2
15.4%
|
26
14.6%
|
9
34.6%
|
| AEs |
13
100%
|
176
98.9%
|
24
92.3%
|
| Drug-related AEs |
13
100%
|
165
92.7%
|
24
92.3%
|
| Discontinuation due to SAEs |
0
0%
|
14
7.9%
|
5
19.2%
|
| Discontinuation due to AEs |
1
7.7%
|
18
10.1%
|
5
19.2%
|
| Deaths |
0
0%
|
1
0.6%
|
0
0%
|
| Title | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time |
|---|---|
| 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 activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score. |
| Time Frame | At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = number of participants assessed at given time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 4; (n=13, 178,26) |
30.8
236.9%
|
29.2
16.4%
|
34.6
133.1%
|
| Week 12; (n=13, 178,24) |
76.9
591.5%
|
47.2
26.5%
|
58.3
224.2%
|
| Week 24; (n=13, 176, 23) |
76.9
591.5%
|
59.7
33.5%
|
78.3
301.2%
|
| Week 36; (n=13, 175, 20) |
69.2
532.3%
|
61.7
34.7%
|
90.0
346.2%
|
| Week 48; (n=13, 170, 18) |
61.5
473.1%
|
63.5
35.7%
|
88.9
341.9%
|
| Week 60; (n=13, 165, 17) |
69.2
532.3%
|
69.7
39.2%
|
94.1
361.9%
|
| Week 72; (n=13, 161, 17) |
84.6
650.8%
|
67.7
38%
|
94.1
361.9%
|
| Week 84; (n=13, 161, 17) |
61.5
473.1%
|
67.1
37.7%
|
100.0
384.6%
|
| Week 96; (n=13, 160, 17) |
69.2
532.3%
|
63.8
35.8%
|
82.4
316.9%
|
| Week 108; (n=13, 156, 15) |
53.8
413.8%
|
67.9
38.1%
|
100.0
384.6%
|
| Week 120; (n=13, 154, 15) |
69.2
532.3%
|
69.5
39%
|
100.0
384.6%
|
| Week 132; (n=13, 151, 14) |
61.5
473.1%
|
68.9
38.7%
|
100.0
384.6%
|
| Week 144; (n=12, 142, 13) |
58.3
448.5%
|
69.7
39.2%
|
84.6
325.4%
|
| Week 156; (n=11, 113, 12) |
63.6
489.2%
|
66.4
37.3%
|
100.0
384.6%
|
| Week 168; (n=10, 80, 8) |
80.0
615.4%
|
71.3
40.1%
|
100.0
384.6%
|
| Week 180; (n=8, 56, 4) |
62.5
480.8%
|
69.6
39.1%
|
100.0
384.6%
|
| Week 192; (n=3, 7, 1) |
66.7
513.1%
|
85.7
48.1%
|
100.0
384.6%
|
| Title | Percentage of Participants With ACR 50 Response Over Time |
|---|---|
| Description | ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score. |
| Time Frame | At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 4; (n=13, 178, 26) |
15.4
118.5%
|
6.2
3.5%
|
0
0%
|
| Week 12; (n=13, 178,24) |
38.5
296.2%
|
16.3
9.2%
|
29.2
112.3%
|
| Week 24; (n=13, 176, 23) |
30.8
236.9%
|
25.6
14.4%
|
47.8
183.8%
|
| Week 36; (n=13, 175, 20) |
38.5
296.2%
|
28.6
16.1%
|
50.0
192.3%
|
| Week 48; (n=13, 170, 18) |
15.4
118.5%
|
38.8
21.8%
|
72.2
277.7%
|
| Week 60; (n=13, 165, 17) |
30.8
236.9%
|
42.4
23.8%
|
58.8
226.2%
|
| Week 72; (n=13, 161, 17) |
46.2
355.4%
|
43.5
24.4%
|
70.6
271.5%
|
| Week 84; (n=13, 161, 17) |
38.5
296.2%
|
42.2
23.7%
|
70.6
271.5%
|
| Week 96; (n=13, 160, 17) |
23.1
177.7%
|
38.1
21.4%
|
58.8
226.2%
|
| Week 108; (n=13, 156, 15) |
23.1
177.7%
|
42.3
23.8%
|
66.7
256.5%
|
| Week 120; (n=13, 154, 15) |
46.2
355.4%
|
45.5
25.6%
|
93.3
358.8%
|
| Week 132; (n=13, 151, 14) |
38.5
296.2%
|
43.7
24.6%
|
85.7
329.6%
|
| Week 144; (n=12, 142, 13) |
25.0
192.3%
|
47.2
26.5%
|
69.2
266.2%
|
| Week 156; (n=11, 113, 12) |
36.4
280%
|
47.8
26.9%
|
83.3
320.4%
|
| Week 168; (n=10, 80, 8) |
30.0
230.8%
|
47.5
26.7%
|
87.5
336.5%
|
| Week 180; (n=8, 56, 4) |
12.5
96.2%
|
51.8
29.1%
|
75.0
288.5%
|
| Week 192; (n=3, 7, 1) |
66.7
513.1%
|
71.4
40.1%
|
100.0
384.6%
|
| Title | Percentage of Participants With ACR 70 Response Over Time |
|---|---|
| Description | ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score. |
| Time Frame | At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 4; (n=13, 178, 26) |
7.7
59.2%
|
0
0%
|
0
0%
|
| Week 12; (n=13, 178, 24) |
7.7
59.2%
|
5.6
3.1%
|
8.3
31.9%
|
| Week 24; (n=13, 176, 23) |
7.7
59.2%
|
10.8
6.1%
|
21.7
83.5%
|
| Week 36; (n=13, 175, 20) |
15.4
118.5%
|
11.4
6.4%
|
20.0
76.9%
|
| Week 48; (n=13, 170, 18) |
15.4
118.5%
|
15.3
8.6%
|
27.8
106.9%
|
| Week 60; (n=13, 165, 17) |
15.4
118.5%
|
19.4
10.9%
|
29.4
113.1%
|
| Week 72; (n=13, 161, 17) |
15.4
118.5%
|
18.6
10.4%
|
23.5
90.4%
|
| Week 84; (n=13, 161, 17) |
7.7
59.2%
|
17.4
9.8%
|
23.5
90.4%
|
| Week 96; (n=13, 160, 17) |
7.7
59.2%
|
19.4
10.9%
|
23.5
90.4%
|
| Week 108; (n=13, 156, 15) |
7.7
59.2%
|
15.4
8.7%
|
33.3
128.1%
|
| Week 120; (n=13, 154, 15) |
7.7
59.2%
|
19.5
11%
|
46.7
179.6%
|
| Week 132; (n=13, 151, 14) |
0
0%
|
20.5
11.5%
|
42.9
165%
|
| Week 144; (n=12, 142, 13) |
0
0%
|
21.8
12.2%
|
23.1
88.8%
|
| Week 156; (n=11, 113, 12) |
0
0%
|
25.7
14.4%
|
33.3
128.1%
|
| Week 168; (n=10, 80, 8) |
0
0%
|
27.5
15.4%
|
62.5
240.4%
|
| Week 180; (n=8, 56, 4) |
0
0%
|
33.9
19%
|
50.0
192.3%
|
| Week 192; (n=3, 7, 1) |
0
0%
|
14.3
8%
|
100.0
384.6%
|
| Title | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) |
|---|---|
| Description | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (change of > 5.1), low disease activity (change of ≤ 3.2) and remission (< 2.6). Please see outcome 8 for change from BL data. |
| Time Frame | At BL (week 0), week 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24- BL (n=13, 176, 21) |
4.4
(1.0)
|
4.8
(1.4)
|
6.3
(1.0)
|
| Week 24- PBL (n=13, 176, 21) |
3.0
(1.1)
|
3.2
(1.1)
|
4.0
(1.9)
|
| Week 48- BL (n=13, 168, 18) |
4.4
(1.0)
|
4.8
(1.4)
|
6.3
(1.0)
|
| Week 48- PBL (n=13, 168, 18) |
3.0
(1.1)
|
2.9
(1.1)
|
3.5
(1.4)
|
| Week 96- BL (n=13, 159, 17) |
4.4
(1.0)
|
4.8
(1.4)
|
6.2
(1.0)
|
| Week 96- PBL (n=13, 159, 17) |
3.3
(1.0)
|
2.8
(1.0)
|
3.2
(1.0)
|
| Week 144- BL (n=12, 142, 13) |
4.3
(0.9)
|
4.9
(1.4)
|
6.3
(1.0)
|
| Week 144- PBL (n=12, 142, 13) |
3.0
(0.9)
|
2.8
(1.0)
|
3.2
(1.2)
|
| Week 192- BL (n=3, 7, 1) |
4.6
(1.6)
|
5.4
(0.9)
|
7.9
(NA)
|
| Week 192- PBL (n=3, 7, 1) |
2.6
(1.2)
|
3.1
(1.4)
|
1.9
(NA)
|
| Title | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 |
|---|---|
| Description | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Please refer to outcome 7 for BL and PBL values. |
| Time Frame | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24 (n=13, 176, 21) |
-1.4
|
-1.7
|
-2.3
|
| Week 48 (n=13, 168, 18) |
-1.4
|
-1.9
|
-2.8
|
| Week 96 (n=13, 159, 17) |
-1.1
|
-2.0
|
-3.0
|
| Week 144 (n=12, 142, 13) |
-1.3
|
-2.1
|
-3.1
|
| Week 192 (n=3, 7, 1) |
-2.0
|
-2.3
|
-6.0
|
| Title | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 |
|---|---|
| Description | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score change ≥ 1.2 from BL were considered to have improvement. |
| Time Frame | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24 (n=13, 176, 21) |
9
69.2%
|
113
63.5%
|
17
65.4%
|
| Week 48 (n=13, 168, 18) |
8
61.5%
|
114
64%
|
16
61.5%
|
| Week 96 (n=13, 159, 17) |
7
53.8%
|
111
62.4%
|
16
61.5%
|
| Week 144 (n=12, 142, 13) |
6
46.2%
|
107
60.1%
|
12
46.2%
|
| Week 192 (n=3, 7, 1) |
3
23.1%
|
5
2.8%
|
1
3.8%
|
| Title | Number of Participants With Abnormal Laboratory Changes (ALC) |
|---|---|
| Description | The laboratory tests were analyses included enzyme, gastrointestinal, hematology, hepatobiliary, lipid, metabolic, nutritional, blood gas, microbiology, serology, protein, chemistry, renal, urinary tract, urinalyses, water, electrolyte and mineral investigations. |
| Time Frame | From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months). |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Participants with Serious ALC |
0
0%
|
0
0%
|
1
3.8%
|
| Discontinuations due Serious ALC |
0
0%
|
0
0%
|
0
0%
|
| Participants with drug related Serious ALC |
0
0%
|
0
0%
|
1
3.8%
|
| Participants with ALC |
0
0%
|
1
0.6%
|
0
0%
|
| Discontinuations due ALC |
7
53.8%
|
125
70.2%
|
19
73.1%
|
| Discontinuations due ALC |
6
46.2%
|
102
57.3%
|
13
50%
|
| Title | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 |
|---|---|
| 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, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score ≤ 3.2 were considered to have low disease activity. |
| Time Frame | At weeks 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24 (n=13, 176, 21) |
9
69.2%
|
95
53.4%
|
6
23.1%
|
| Week 48 (n=13, 168, 18) |
9
69.2%
|
105
59%
|
7
26.9%
|
| Week 96 (n=13, 159, 17) |
6
46.2%
|
101
56.7%
|
6
23.1%
|
| Week 144 (n=12, 142, 13) |
6
46.2%
|
95
53.4%
|
7
26.9%
|
| Week 192 (n=3, 7, 1) |
2
15.4%
|
3
1.7%
|
1
3.8%
|
| Title | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 |
|---|---|
| Description | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score < 2.6 were considered to be in remission. |
| Time Frame | At weeks 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24 (n=13, 176, 21) |
6
46.2%
|
60
33.7%
|
6
23.1%
|
| Week 48 (n=13, 168, 18) |
4
30.8%
|
75
42.1%
|
5
19.2%
|
| Week 96 (n=13, 159, 17) |
3
23.1%
|
75
42.1%
|
5
19.2%
|
| Week 144 (n=12, 142, 13) |
4
30.8%
|
71
39.9%
|
3
11.5%
|
| Week 192 (n=3, 7, 1) |
2
15.4%
|
2
1.1%
|
1
3.8%
|
| Title | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 |
|---|---|
| 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 BL in HAQ. |
| Time Frame | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24 (n=13, 176, 23) |
38.5
296.2%
|
39.2
22%
|
52.2
200.8%
|
| Week 48 (n=13, 170, 18) |
30.8
236.9%
|
41.2
23.1%
|
77.8
299.2%
|
| Week 96 (n=13, 160, 17) |
46.2
355.4%
|
47.5
26.7%
|
76.5
294.2%
|
| Week 144 (n=12, 142, 13) |
50.0
384.6%
|
48.6
27.3%
|
69.2
266.2%
|
| Week 192 (n=3, 7, 1) |
100.0
769.2%
|
85.7
48.1%
|
100.0
384.6%
|
| Title | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores |
|---|---|
| Description | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 14 for change from BL data. |
| Time Frame | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24- BL (n=13, 176, 23) |
34.2
(14.5)
|
30.3
(15.2)
|
19.0
(12.5)
|
| Week 24- PBL (n=13, 176, 23) |
40.6
(12.6)
|
38.5
(14.3)
|
30.3
(17.1)
|
| Week 48- BL (n=13, 170, 18) |
34.2
(14.5)
|
30.4
(15.2)
|
20.1
(12.4)
|
| Week 48- PBL (n=13, 170, 18) |
40.9
(11.1)
|
40.1
(13.7)
|
37.1
(14.0)
|
| Week 96- BL (n=13, 160, 17) |
34.2
(14.5)
|
29.8
(15.2)
|
19.9
(12.7)
|
| Week 96- PBL (n=13, 160, 17) |
38.7
(12.6)
|
40.3
(13.2)
|
37.5
(13.5)
|
| Week 144- BL (n=12, 142, 13) |
32.9
(14.4)
|
30.6
(15.1)
|
21.1
(14.0)
|
| Week 144- PBL (n=12, 142, 13) |
37.8
(14.5)
|
39.2
(13.7)
|
32.9
(14.2)
|
| Week 192- BL (n=3, 7, 1) |
24.6
(10.9)
|
22.8
(12.2)
|
12.5
(NA)
|
| Week 192- PBL (n=3, 7, 1) |
30.4
(24.8)
|
38.5
(16.1)
|
37.0
(NA)
|
| Title | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 |
|---|---|
| Description | The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful. Please see outcome 13 for BL and PBL values. |
| Time Frame | At baseline (week 0), weeks 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24 (n=13, 176, 23) |
6.5
|
8.2
|
11.3
|
| Week 48 (n=13, 170, 18) |
6.7
|
9.7
|
17.1
|
| Week 96 (n=13, 160, 17) |
4.5
|
10.4
|
17.6
|
| Week 144 (n=12, 142, 13) |
4.8
|
8.6
|
11.8
|
| Week 192 (n=3, 7, 1) |
5.7
|
15.7
|
24.6
|
| Title | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores |
|---|---|
| Description | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Please see outcome 14 for change from BL data. |
| Time Frame | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24- BL (n=13, 176, 23) |
41.6
(12.4)
|
48.6
(8.5)
|
41.7
(9.8)
|
| Week 24- PBL (n=13, 176, 23) |
45.2
(8.9)
|
51.2
(7.5)
|
49.5
(10.5)
|
| Week 48- BL (n=13, 170, 18) |
41.6
(12.4)
|
48.6
(8.5)
|
43.2
(9.6)
|
| Week 48- PBL (n=13, 170, 18) |
49.0
(8.0)
|
51.6
(8.1)
|
49.9
(7.5)
|
| Week 96- BL (n=13, 160, 17) |
41.6
(12.4)
|
48.6
(8.5)
|
43.6
(9.8)
|
| Week 96- PBL (n=13, 160, 17) |
49.9
(7.2)
|
50.6
(7.5)
|
51.6
(8.2)
|
| Week 144- BL (n=12, 142, 13) |
41.6
(13.0)
|
48.5
(8.6)
|
42.2
(9.4)
|
| Week 144- PBL (n=12, 142, 13) |
51.1
(7.6)
|
50.6
(7.3)
|
51.1
(8.4)
|
| Week 192- BL (n=3, 7, 1) |
45.7
(20.4)
|
45.4
(8.1)
|
37.1
(NA)
|
| Week 192- PBL (n=3, 7, 1) |
60.7
(6.1)
|
52.4
(12.5)
|
69.3
(NA)
|
| Title | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 |
|---|---|
| Description | The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 15 for BL and PBL values. |
| Time Frame | At BL (Week 0), weeks 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24 (n=13, 176, 23) |
3.6
|
2.6
|
7.7
|
| Week 48 (n=13, 170, 18) |
7.4
|
3.0
|
6.7
|
| Week 96 (n=13, 160, 17) |
8.3
|
2.1
|
8.0
|
| Week 144 (n=12, 142, 13) |
9.5
|
2.1
|
8.9
|
| Week 192 (n=3, 7, 1) |
15.0
|
7.0
|
32.1
|
| Title | Baseline and Postbaseline C-reactive Protein (CRP) Levels |
|---|---|
| Description | CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Please see outcome 18 for change from BL data. |
| Time Frame | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = number of participants with both BL and PBL measurement at a given point time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24- BL (n=13, 176, 21) |
1.8
(2.8)
|
2.3
(2.2)
|
3.9
(3.1)
|
| Week 24- PBL (n=13, 176, 21) |
0.7
(0.7)
|
0.8
(1.3)
|
1.9
(2.5)
|
| Week 48- BL (n=13, 168, 18) |
1.8
(2.8)
|
2.2
(2.1)
|
4.1
(3.1)
|
| Week 48- PBL (n=13, 168, 18) |
1.1
(2.1)
|
0.6
(1.1)
|
0.9
(1.3)
|
| Week 96- BL (n=13, 159, 17) |
1.8
(2.8)
|
2.3
(2.2)
|
4.1
(3.2)
|
| Week 96- PBL (n=13, 159, 17) |
0.9
(1.3)
|
0.5
(0.9)
|
1.0
(1.0)
|
| Week 144- BL (n=12, 142, 13) |
1.9
(2.9)
|
2.4
(2.2)
|
4.2
(3.4)
|
| Week 144- PBL (n=12, 142, 13) |
1.2
(1.4)
|
0.6
(1.5)
|
0.6
(0.6)
|
| Week 192- BL (n=3, 7, 1) |
4.6
(5.4)
|
1.7
(1.2)
|
8.4
(NA)
|
| Week 192- PBL (n=3, 7, 1) |
1.4
(1.7)
|
0.8
(1.6)
|
0.2
(NA)
|
| Title | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 |
|---|---|
| Description | CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease, negative values indicate improvement. Percentage improvement from BL = (BL - PBL value) / BL value * 100. Please refer to outcome 17 for BL and PBL values. |
| Time Frame | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24 (n=13, 176, 21) |
-18.4
|
30.5
|
60.2
|
| Week 48 (n=13, 168, 18) |
12.0
|
31.9
|
77.8
|
| Week 96 (n=13, 159, 17) |
-3.3
|
40.5
|
70.1
|
| Week 144 (n=12, 142, 13) |
-71.9
|
-39.3
|
79.9
|
| Week 192 (n=3, 7, 1) |
67.9
|
39.7
|
97.4
|
| Title | Baseline and Postbaseline Rheumatoid Factor Levels |
|---|---|
| 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. RF levels are considered positive if value is >20 and considered negative if value is <20. Please see outcome 20 for change from BL data. |
| Time Frame | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24- BL (n=13, 176, 21) |
200.2
(343.8)
|
214.3
(383.3)
|
630.8
(873.4)
|
| Week 24- PBL (n=13, 176, 21) |
127.5
(191.6)
|
141.0
(289.2)
|
573.9
(897.2)
|
| Week 48- BL (n=13, 168, 18) |
200.2
(343.8)
|
217.3
(389.7)
|
560.9
(893.0)
|
| Week 48- PBL (n=13, 168, 18) |
139.9
(241.8)
|
149.5
(288.4)
|
288.3
(482.8)
|
| Week 96- BL (n=13, 159, 17) |
200.2
(343.8)
|
215.9
(393.9)
|
590.9
(911.1)
|
| Week 96- PBL (n=13, 159, 17) |
186.9
(339.4)
|
151.0
(285.8)
|
216.8
(329.2)
|
| Week 144- BL (n=12, 142, 13) |
205.6
(358.5)
|
229.0
(412.6)
|
639.4
(990.8)
|
| Week 144- PBL (n=12, 142, 13) |
211.3
(359.8)
|
173.7
(360.8)
|
361.6
(663.9)
|
| Week 192- BL (n=3, 7, 1) |
314.3
(455.3)
|
253.7
(307.6)
|
2800.0
(NA)
|
| Week 192- PBL (n=3, 7, 1) |
315.0
(307.0)
|
348.4
(521.6)
|
197.0
(NA)
|
| Title | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 |
|---|---|
| Description | RF 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. RF levels are considered positive if value is >20 and considered negative if value is <20. Please refer to outcome 19 for BL and PBL values. |
| Time Frame | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Week 24 (n=13, 176, 21) |
-72.6
|
-73.2
|
-56.9
|
| Week 48 (n=13, 168, 18) |
-60.2
|
-67.8
|
-272.6
|
| Week 96 (n=13, 159, 17) |
-13.2
|
-64.9
|
-374.1
|
| Week 144 (n=12, 142, 13) |
5.7
|
-55.3
|
-277.8
|
| Week 192 (n=3, 7, 1) |
0.7
|
94.7
|
-2603
|
| Title | Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies |
|---|---|
| Description | Validated enzyme-linked immunoassay (ELISA) method was used to measure anti-abatacept and anti-CTLA4-T antibody levels. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. |
| Time Frame | At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received study treatment, and had BL and at least one PBL measurement for immunogenicity. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Positive for anti-abatacept antibody |
2
15.4%
|
19
10.7%
|
2
7.7%
|
| Positive for anti-CTLA4-T antibody |
0
0%
|
19
10.7%
|
1
3.8%
|
| Title | Abatacept PK Parameter: Total Body Clearance |
|---|---|
| Description | Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism. |
| Time Frame | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received abatacept and had blood samples for assay. |
| Arm/Group Title | All Participants From IM101-129 Study |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. |
| Measure Participants | 113 |
| Median (Full Range) [L/day] |
0.306
(0.098)
|
| Title | Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State |
|---|---|
| Description | Area under the plasma concentration-time curve (AUCss) at steady state for each dosing interval was determined using the linear trapezoidal rule. |
| Time Frame | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received abatacept and had blood samples for assay. |
| Arm/Group Title | All Participants From IM101-129 Study |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. |
| Measure Participants | 113 |
| Median (Full Range) [µg*h/mL] |
42959.94
(12763.45)
|
| Title | Abatacept PK Parameter: Maximum Serum Concentration at Steady State |
|---|---|
| Description | Maximum plasma concentration is the maximum observed serum drug concentration at steady state (Css max). |
| Time Frame | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received abatacept and had blood samples for assay. |
| Arm/Group Title | All Participants From IM101-129 Study |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. |
| Measure Participants | 113 |
| Median (Full Range) [µg/mL] |
241.62
(73.96)
|
| Title | Abatacept PK Parameter: Minimum Plasma Concentration at Steady State |
|---|---|
| Description | Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration at steady state. |
| Time Frame | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received abatacept and had blood samples for assay. |
| Arm/Group Title | All Participants From IM101-129 Study |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. |
| Measure Participants | 113 |
| Median (Full Range) [µg/mL] |
26.14
(23.10)
|
| Title | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator |
|---|---|
| Description | |
| Time Frame | At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months). |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of the study drug. |
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| Measure Participants | 13 | 178 | 26 |
| Blood pressure increased |
2
15.4%
|
27
15.2%
|
12
46.2%
|
| Blood pressure decreased |
1
7.7%
|
11
6.2%
|
1
3.8%
|
| Blood pressure diastolic decreased |
0
0%
|
7
3.9%
|
0
0%
|
| Blood pressure systolic increased |
0
0%
|
3
1.7%
|
2
7.7%
|
| Weight decreased |
0
0%
|
5
2.8%
|
0
0%
|
| Weight increased |
0
0%
|
3
1.7%
|
1
3.8%
|
| Body temperature decreased |
0
0%
|
3
1.7%
|
0
0%
|
| Body temperature increased |
0
0%
|
2
1.1%
|
0
0%
|
| Blood pressure systolic decreased |
1
7.7%
|
1
0.6%
|
1
3.8%
|
| Blood pressure diastolic increased |
0
0%
|
1
0.6%
|
0
0%
|
| Electrocardiogram abnormal |
0
0%
|
1
0.6%
|
0
0%
|
| Electrocardiogram ST segment depression |
0
0%
|
1
0.6%
|
0
0%
|
| Electrocardiogram ST-T segment abnormal |
0
0%
|
1
0.6%
|
0
0%
|
| Heart rate increased |
0
0%
|
2
1.1%
|
0
0%
|
| Heart rate decreased |
0
0%
|
1
0.6%
|
0
0%
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg | |||
| Arm/Group Description | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | |||
All Cause Mortality |
||||||
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/13 (30.8%) | 50/178 (28.1%) | 14/26 (53.8%) | |||
| Cardiac disorders | ||||||
| Atrial fibrillation | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Cardiac failure | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Mitral valve incompetence | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Prinzmetal angina | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Deafness | 0/13 (0%) | 0/178 (0%) | 1/26 (3.8%) | |||
| Vertigo | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Vertigo positional | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Eye disorders | ||||||
| Cataract | 0/13 (0%) | 1/178 (0.6%) | 1/26 (3.8%) | |||
| Gastrointestinal disorders | ||||||
| Anal fistula | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Gastric ulcer | 0/13 (0%) | 0/178 (0%) | 1/26 (3.8%) | |||
| Inflammatory bowel disease | 0/13 (0%) | 0/178 (0%) | 1/26 (3.8%) | |||
| Radicular cyst | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Volvulus | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| General disorders | ||||||
| Feeling abnormal | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Pyrexia | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Hepatobiliary disorders | ||||||
| Cholelithiasis | 1/13 (7.7%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Infections and infestations | ||||||
| Acute sinusitis | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Appendicitis | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Arthritis bacterial | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Bronchitis | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Bronchopneumonia | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Cellulitis | 0/13 (0%) | 2/178 (1.1%) | 1/26 (3.8%) | |||
| Fungal infection | 0/13 (0%) | 0/178 (0%) | 1/26 (3.8%) | |||
| Gastroenteritis | 1/13 (7.7%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Gastroenteritis viral | 0/13 (0%) | 0/178 (0%) | 1/26 (3.8%) | |||
| Osteomyelitis | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Otitis media chronic | 0/13 (0%) | 0/178 (0%) | 1/26 (3.8%) | |||
| Pharyngeal abscess | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Pneumonia | 0/13 (0%) | 2/178 (1.1%) | 0/26 (0%) | |||
| Sepsis | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Subcutaneous abscess | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Contusion | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Femoral neck fracture | 0/13 (0%) | 1/178 (0.6%) | 1/26 (3.8%) | |||
| Femur fracture | 1/13 (7.7%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Humerus fracture | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Joint dislocation | 0/13 (0%) | 2/178 (1.1%) | 0/26 (0%) | |||
| Joint injury | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Lower limb fracture | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Meniscus lesion | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Patella fracture | 0/13 (0%) | 2/178 (1.1%) | 0/26 (0%) | |||
| Rib fracture | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Spinal compression fracture | 0/13 (0%) | 2/178 (1.1%) | 1/26 (3.8%) | |||
| Tendon rupture | 0/13 (0%) | 1/178 (0.6%) | 1/26 (3.8%) | |||
| Ulna fracture | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Investigations | ||||||
| C-reactive protein increased | 0/13 (0%) | 0/178 (0%) | 1/26 (3.8%) | |||
| Metabolism and nutrition disorders | ||||||
| Diabetes mellitus | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Arthritis | 0/13 (0%) | 2/178 (1.1%) | 0/26 (0%) | |||
| Foot deformity | 1/13 (7.7%) | 4/178 (2.2%) | 0/26 (0%) | |||
| Head deformity | 0/13 (0%) | 0/178 (0%) | 1/26 (3.8%) | |||
| Joint destruction | 0/13 (0%) | 5/178 (2.8%) | 1/26 (3.8%) | |||
| Knee deformity | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Musculoskeletal stiffness | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Osteitis | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Osteoarthritis | 1/13 (7.7%) | 1/178 (0.6%) | 2/26 (7.7%) | |||
| Spinal column stenosis | 0/13 (0%) | 1/178 (0.6%) | 1/26 (3.8%) | |||
| Tenosynovitis stenosans | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| B-cell lymphoma | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Breast cancer | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Cervix carcinoma stage 0 | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Diffuse large B-cell lymphoma | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Endometrial cancer | 0/13 (0%) | 0/178 (0%) | 1/26 (3.8%) | |||
| Gastric cancer | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Neoplasm | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Pancreatic carcinoma | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Pinealoma | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| T-cell lymphoma | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Uterine leiomyoma | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Nervous system disorders | ||||||
| Cerebral haemorrhage | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Cerebral infarction | 0/13 (0%) | 1/178 (0.6%) | 1/26 (3.8%) | |||
| Encephalitis | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Hydrocephalus | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Hypoaesthesia | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Neuropathy peripheral | 0/13 (0%) | 0/178 (0%) | 1/26 (3.8%) | |||
| Sensory disturbance | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Thalamus haemorrhage | 0/13 (0%) | 0/178 (0%) | 1/26 (3.8%) | |||
| VIIth nerve paralysis | 0/13 (0%) | 0/178 (0%) | 1/26 (3.8%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Bronchitis chronic | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Interstitial lung disease | 0/13 (0%) | 1/178 (0.6%) | 1/26 (3.8%) | |||
| Surgical and medical procedures | ||||||
| Bunion operation | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Gastric polypectomy | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Knee arthroplasty | 0/13 (0%) | 1/178 (0.6%) | 0/26 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/13 (100%) | 176/178 (98.9%) | 24/26 (92.3%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/13 (0%) | 9/178 (5.1%) | 1/26 (3.8%) | |||
| Cardiac disorders | ||||||
| Cardiac failure | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Cardiomegaly | 1/13 (7.7%) | 2/178 (1.1%) | 0/26 (0%) | |||
| Tachycardia | 1/13 (7.7%) | 3/178 (1.7%) | 0/26 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 1/13 (7.7%) | 7/178 (3.9%) | 2/26 (7.7%) | |||
| Eye disorders | ||||||
| Blepharitis | 1/13 (7.7%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Cataract | 0/13 (0%) | 4/178 (2.2%) | 3/26 (11.5%) | |||
| Dry eye | 0/13 (0%) | 9/178 (5.1%) | 1/26 (3.8%) | |||
| Eye discharge | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal discomfort | 0/13 (0%) | 10/178 (5.6%) | 1/26 (3.8%) | |||
| Abdominal pain upper | 1/13 (7.7%) | 11/178 (6.2%) | 1/26 (3.8%) | |||
| Colonic polyp | 1/13 (7.7%) | 2/178 (1.1%) | 0/26 (0%) | |||
| Constipation | 0/13 (0%) | 21/178 (11.8%) | 5/26 (19.2%) | |||
| Dental caries | 0/13 (0%) | 21/178 (11.8%) | 0/26 (0%) | |||
| Diarrhoea | 1/13 (7.7%) | 10/178 (5.6%) | 2/26 (7.7%) | |||
| Enterocolitis | 1/13 (7.7%) | 3/178 (1.7%) | 1/26 (3.8%) | |||
| Gastric polyps | 1/13 (7.7%) | 7/178 (3.9%) | 1/26 (3.8%) | |||
| Gastric ulcer | 0/13 (0%) | 2/178 (1.1%) | 2/26 (7.7%) | |||
| Gastritis | 1/13 (7.7%) | 18/178 (10.1%) | 1/26 (3.8%) | |||
| Gastrointestinal motility disorder | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Haemorrhoids | 2/13 (15.4%) | 3/178 (1.7%) | 2/26 (7.7%) | |||
| Inguinal hernia | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Nausea | 2/13 (15.4%) | 14/178 (7.9%) | 2/26 (7.7%) | |||
| Periodontitis | 0/13 (0%) | 5/178 (2.8%) | 2/26 (7.7%) | |||
| Stomatitis | 4/13 (30.8%) | 46/178 (25.8%) | 3/26 (11.5%) | |||
| Toothache | 1/13 (7.7%) | 2/178 (1.1%) | 0/26 (0%) | |||
| Vomiting | 0/13 (0%) | 8/178 (4.5%) | 3/26 (11.5%) | |||
| General disorders | ||||||
| Malaise | 1/13 (7.7%) | 8/178 (4.5%) | 1/26 (3.8%) | |||
| Pyrexia | 1/13 (7.7%) | 11/178 (6.2%) | 4/26 (15.4%) | |||
| Thirst | 0/13 (0%) | 2/178 (1.1%) | 2/26 (7.7%) | |||
| Immune system disorders | ||||||
| Seasonal allergy | 1/13 (7.7%) | 14/178 (7.9%) | 2/26 (7.7%) | |||
| Infections and infestations | ||||||
| Bronchitis | 2/13 (15.4%) | 15/178 (8.4%) | 1/26 (3.8%) | |||
| Cystitis | 4/13 (30.8%) | 11/178 (6.2%) | 0/26 (0%) | |||
| Dermatitis infected | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Diverticulitis | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Folliculitis | 1/13 (7.7%) | 4/178 (2.2%) | 0/26 (0%) | |||
| Gastroenteritis | 2/13 (15.4%) | 16/178 (9%) | 3/26 (11.5%) | |||
| Herpes simplex | 1/13 (7.7%) | 1/178 (0.6%) | 1/26 (3.8%) | |||
| Herpes zoster | 0/13 (0%) | 9/178 (5.1%) | 1/26 (3.8%) | |||
| Nasopharyngitis | 8/13 (61.5%) | 103/178 (57.9%) | 12/26 (46.2%) | |||
| Oesophageal candidiasis | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Onychomycosis | 1/13 (7.7%) | 5/178 (2.8%) | 0/26 (0%) | |||
| Oral herpes | 1/13 (7.7%) | 8/178 (4.5%) | 1/26 (3.8%) | |||
| Pharyngitis | 0/13 (0%) | 24/178 (13.5%) | 4/26 (15.4%) | |||
| Rhinitis | 0/13 (0%) | 9/178 (5.1%) | 0/26 (0%) | |||
| Sinusitis | 0/13 (0%) | 11/178 (6.2%) | 2/26 (7.7%) | |||
| Tinea pedis | 1/13 (7.7%) | 10/178 (5.6%) | 1/26 (3.8%) | |||
| Injury, poisoning and procedural complications | ||||||
| Arthropod sting | 2/13 (15.4%) | 5/178 (2.8%) | 0/26 (0%) | |||
| Contusion | 2/13 (15.4%) | 9/178 (5.1%) | 1/26 (3.8%) | |||
| Excoriation | 1/13 (7.7%) | 3/178 (1.7%) | 1/26 (3.8%) | |||
| Muscle strain | 2/13 (15.4%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Tendon rupture | 1/13 (7.7%) | 0/178 (0%) | 2/26 (7.7%) | |||
| Thermal burn | 1/13 (7.7%) | 3/178 (1.7%) | 0/26 (0%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 2/13 (15.4%) | 29/178 (16.3%) | 2/26 (7.7%) | |||
| Aspartate aminotransferase increased | 1/13 (7.7%) | 23/178 (12.9%) | 1/26 (3.8%) | |||
| Blood alkaline phosphatase increased | 0/13 (0%) | 7/178 (3.9%) | 3/26 (11.5%) | |||
| Blood glucose increased | 1/13 (7.7%) | 9/178 (5.1%) | 3/26 (11.5%) | |||
| Blood pressure decreased | 1/13 (7.7%) | 11/178 (6.2%) | 1/26 (3.8%) | |||
| Blood pressure increased | 2/13 (15.4%) | 27/178 (15.2%) | 12/26 (46.2%) | |||
| Blood pressure systolic decreased | 1/13 (7.7%) | 1/178 (0.6%) | 1/26 (3.8%) | |||
| Blood pressure systolic increased | 0/13 (0%) | 3/178 (1.7%) | 2/26 (7.7%) | |||
| Blood urea increased | 1/13 (7.7%) | 6/178 (3.4%) | 0/26 (0%) | |||
| Blood urine present | 1/13 (7.7%) | 14/178 (7.9%) | 1/26 (3.8%) | |||
| Brain natriuretic peptide increased | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Eosinophil count increased | 0/13 (0%) | 9/178 (5.1%) | 4/26 (15.4%) | |||
| Gamma-glutamyltransferase increased | 0/13 (0%) | 15/178 (8.4%) | 1/26 (3.8%) | |||
| Glucose urine present | 0/13 (0%) | 11/178 (6.2%) | 2/26 (7.7%) | |||
| Lymphocyte count decreased | 1/13 (7.7%) | 35/178 (19.7%) | 5/26 (19.2%) | |||
| Protein total decreased | 0/13 (0%) | 4/178 (2.2%) | 2/26 (7.7%) | |||
| Red blood cells urine positive | 1/13 (7.7%) | 13/178 (7.3%) | 2/26 (7.7%) | |||
| White blood cell count increased | 1/13 (7.7%) | 29/178 (16.3%) | 7/26 (26.9%) | |||
| White blood cells urine positive | 3/13 (23.1%) | 18/178 (10.1%) | 3/26 (11.5%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 1/13 (7.7%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Hypercholesterolaemia | 0/13 (0%) | 4/178 (2.2%) | 2/26 (7.7%) | |||
| Hyperlipidaemia | 1/13 (7.7%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Hyperuricaemia | 2/13 (15.4%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 0/13 (0%) | 4/178 (2.2%) | 2/26 (7.7%) | |||
| Atlantoaxial instability | 1/13 (7.7%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Back pain | 1/13 (7.7%) | 22/178 (12.4%) | 3/26 (11.5%) | |||
| Intervertebral disc protrusion | 1/13 (7.7%) | 6/178 (3.4%) | 1/26 (3.8%) | |||
| Muscle spasms | 1/13 (7.7%) | 6/178 (3.4%) | 0/26 (0%) | |||
| Myalgia | 2/13 (15.4%) | 4/178 (2.2%) | 0/26 (0%) | |||
| Osteoporosis | 1/13 (7.7%) | 12/178 (6.7%) | 2/26 (7.7%) | |||
| Spinal column stenosis | 1/13 (7.7%) | 3/178 (1.7%) | 1/26 (3.8%) | |||
| Spinal osteoarthritis | 1/13 (7.7%) | 8/178 (4.5%) | 1/26 (3.8%) | |||
| Tendon disorder | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Nervous system disorders | ||||||
| Dizziness | 0/13 (0%) | 9/178 (5.1%) | 3/26 (11.5%) | |||
| Headache | 0/13 (0%) | 15/178 (8.4%) | 3/26 (11.5%) | |||
| Hypoaesthesia | 1/13 (7.7%) | 7/178 (3.9%) | 0/26 (0%) | |||
| Sciatica | 1/13 (7.7%) | 3/178 (1.7%) | 1/26 (3.8%) | |||
| Syncope | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Psychiatric disorders | ||||||
| Insomnia | 2/13 (15.4%) | 20/178 (11.2%) | 4/26 (15.4%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 1/13 (7.7%) | 21/178 (11.8%) | 0/26 (0%) | |||
| Oropharyngeal discomfort | 1/13 (7.7%) | 1/178 (0.6%) | 0/26 (0%) | |||
| Oropharyngeal pain | 2/13 (15.4%) | 9/178 (5.1%) | 0/26 (0%) | |||
| Pharyngeal erythema | 1/13 (7.7%) | 2/178 (1.1%) | 1/26 (3.8%) | |||
| Rhinitis allergic | 2/13 (15.4%) | 11/178 (6.2%) | 1/26 (3.8%) | |||
| Upper respiratory tract inflammation | 5/13 (38.5%) | 28/178 (15.7%) | 2/26 (7.7%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Acne | 1/13 (7.7%) | 1/178 (0.6%) | 1/26 (3.8%) | |||
| Eczema | 1/13 (7.7%) | 29/178 (16.3%) | 2/26 (7.7%) | |||
| Hyperkeratosis | 0/13 (0%) | 15/178 (8.4%) | 2/26 (7.7%) | |||
| Rash | 2/13 (15.4%) | 15/178 (8.4%) | 4/26 (15.4%) | |||
| Skin exfoliation | 1/13 (7.7%) | 0/178 (0%) | 0/26 (0%) | |||
| Urticaria | 0/13 (0%) | 2/178 (1.1%) | 2/26 (7.7%) | |||
| Vascular disorders | ||||||
| Hypertension | 2/13 (15.4%) | 13/178 (7.3%) | 1/26 (3.8%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
| Name/Title | BMS Study Director |
|---|---|
| Organization | Bristol-Myers Squibb |
| Phone | |
| Clinical.Trials@bms.com |
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00484289
Other Study ID Numbers:
- IM101-129
First Posted:
Jun 8, 2007
Last Update Posted:
Jun 24, 2013
Last Verified:
Jun 1, 2013