Phase 3
Completed N=217
A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00484289 ↗Enrolled (actual)
217
Serious AEs
31.3%
Results posted
Aug 2012
Primary outcomePrimary: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs — 4; 50; 14; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs |
4; 50; 14; 2; 26; 9 | — |
| PRIMARY Number of Participants With Abnormal Laboratory Changes (ALC) |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator |
2; 27; 12; 1; 11; 1 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time |
30.8; 29.2; 34.6; 76.9; 47.2; 58.3 | — |
| SECONDARY Percentage of Participants With ACR 50 Response Over Time |
15.4; 6.2; 0; 38.5; 16.3; 29.2 | — |
| SECONDARY Percentage of Participants With ACR 70 Response Over Time |
7.7; 0; 0; 7.7; 5.6; 8.3 | — |
| SECONDARY Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) |
4.4; 4.8; 6.3; 3.0; 3.2; 4.0 | — |
| SECONDARY Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 |
-1.4; -1.7; -2.3; -1.4; -1.9; -2.8 | — |
| SECONDARY Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 |
9; 113; 17; 8; 114; 16 | — |
| SECONDARY Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 |
9; 95; 6; 9; 105; 7 | — |
| SECONDARY Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 |
6; 60; 6; 4; 75; 5 | — |
| SECONDARY 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 |
38.5; 39.2; 52.2; 30.8; 41.2; 77.8 | — |
| SECONDARY Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores |
34.2; 30.3; 19.0; 40.6; 38.5; 30.3 | — |
| SECONDARY 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 |
6.5; 8.2; 11.3; 6.7; 9.7; 17.1 | — |
| SECONDARY Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores |
41.6; 48.6; 41.7; 45.2; 51.2; 49.5 | — |
| SECONDARY 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 |
3.6; 2.6; 7.7; 7.4; 3.0; 6.7 | — |
| SECONDARY Baseline and Postbaseline C-reactive Protein (CRP) Levels |
1.8; 2.3; 3.9; 0.7; 0.8; 1.9 | — |
| SECONDARY Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 |
-18.4; 30.5; 60.2; 12.0; 31.9; 77.8 | — |
| SECONDARY Baseline and Postbaseline Rheumatoid Factor Levels |
200.2; 214.3; 630.8; 127.5; 141.0; 573.9 | — |
| SECONDARY Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 |
-72.6; -73.2; -56.9; -60.2; -67.8; -272.6 | — |
| SECONDARY Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies |
2; 19; 2; 0; 19; 1 | — |
| SECONDARY Abatacept PK Parameter: Total Body Clearance |
0.306 | — |
| SECONDARY Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State |
42959.94 | — |
| SECONDARY Abatacept PK Parameter: Maximum Serum Concentration at Steady State |
241.62 | — |
| SECONDARY Abatacept PK Parameter: Minimum Plasma Concentration at Steady State |
26.14 | — |
Eligibility Criteria
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 2 times upper limit of normal (ULN), Serum alanine transaminase or aspartate aminotransferase > 2 times ULN.
Data sourced from ClinicalTrials.gov (NCT00484289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.