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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Number of Participants With Abnormal Laboratory Changes (ALC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1: Participants from Phase I study (IM101-034)
干预措施: Abatacept (Drug)
Arm 2: Participants from Phase II study (IM101-071)
干预措施: Abatacept (Drug)
Arm 3: New Participants with Methotrexate (MTX) Intolerance
干预措施: Abatacept (Drug)
结局指标
主要结局
Number of Participants With Abnormal Laboratory Changes (ALC)
时间窗: 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
时间窗: 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).
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs
时间窗: 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.
次要结局
- 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.)
- Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)(At BL (week 0), week 24, 48, 96, 144, and 192.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- Baseline and Postbaseline C-reactive Protein (CRP) Levels(At BL (week 0), weeks 24, 48, 96, 144, and 192.)
- 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.)
- 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.)
- 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.)
- 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.)
- Baseline and Postbaseline Rheumatoid Factor Levels(At BL (week 0), weeks 24, 48, 96, 144, and 192.)
- 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.)
- 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.)
- 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.)
- 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.)