NCT01272908已完成3 期
Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Percentage of Participants With Adverse Events During the Initial Treatment Period - Overall Summary
研究概览
简要总结
This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on study treatment is 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 18-80 years of age
- •Moderate to severe active rheumatoid arthritis
- •Inadequate response to a single previous or current treatment with an anti-TNF agent
- •Methotrexate for at least 12 weeks, at a stable dose over the past 4 weeks
排除标准
- •Previous treatment with MabThera
- •Use of an anti-TNF agent within past 8 weeks (4 in the case of etanercept)
- •Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
- •Active infection, or history of serious or chronic infection
研究组 & 干预措施
Single arm
Experimental
干预措施: rituximab (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events During the Initial Treatment Period - Overall Summary
时间窗: Days 1, 2, 15, and 16 and Week 48 of Initial treatment period
Percentage of participants who reported an AE or serious AE (SAE), a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.
次要结局
- Percentage of Participants With Adverse Events During the Re-Treatment Period - Overall Summary(Days 1, 2, 15, and 16 and Week 48 of Re-treatment period)
- Percentage of Participants Meeting American College of Rheumatology (ACR) Response Criteria During the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Percentage of Participants Meeting ACR Response Criteria During the Re-treatment Period(Weeks 12 and 24 of Re-treatment period)
- Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Re-Treatment Period(Weeks 12 and 24 of Re-treatment period)
- Percentage of Participants Meeting European League Against Rheumatism (EULAR) Response Criteria During the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Percentage of Participants Meeting EULAR Response Criteria During the Re-Treatment Period(Weeks 12 and 24 of Re-treatment period)
- Change From Baseline in DAS28 During the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Change From Baseline in DAS28 During the Re-Treatment Period(Weeks 12 and 24 of Re-treatment period)
- Change From Baseline in SJC During the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Change From Baseline in SJC During the Re-Treatment Period(Weeks 12 and 24 of Re-treatment period)
- Change From Baseline in TJC During the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Change From Baseline in TJC During the Re-Treatment Period(Weeks 12 and 24 of Re-treatment period)
- Change From Baseline in Physician's Global Assessment of Disease Activity During the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Change From Baseline in Physician's Global Assessment of Disease Activity During the Re-Treatment Period(Weeks 12 and 24 of Re-treatment period)
- Change From Baseline in Patient Global Assessment of Disease Activity Score During the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Change From Baseline in Patient Global Assessment of Disease Activity During the Re-Treatment Period(Weeks 12 and 24 of Re-treatment period and Week 4 after last maintenance)
- Change From Baseline in Patient Global Assessment of Pain During the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Change From Baseline in Patient Global Assessment of Pain During the Re-Treatment Period(Weeks 12 and 24 of Re-treatment period)
- Change From Baseline HAQ-DI Score During the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Change From Baseline HAQ-DI Score During the Re-Treatment Period(Weeks 12 and 24 of Re-treatment period)
- Change From Baseline in ESR During the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Change From Baseline in ESR During the Re-Treatment Period(Weeks 12 and 24 of Re-treatment period)
- Change From Baseline in CRP During the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Change From Baseline CRP During the Re-Treatment Period(Weeks 12 and 24 of Re-treatment period)
- Percentage of Participants With Disease Remission According to DAS28 in the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Percentage of Participants With Disease Remission According to DAS28 in the Re-Treatment Period(Weeks 12 and 24 of Re-treatment period)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score During the Initial Treatment Period(Weeks 4, 12, 24, 36, and 48 of Initial treatment period)
- Change From Baseline in FACIT-F Total Score During the Re-Treatment Period(Weeks 12 and 24 of Re-treatment period)
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