NCT00750880已完成3 期
International Multi-Center Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have An Inadequate Response to Current Non-Biologic DMARD or Anti-TNF Therapy.
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
- 1,681
- 主要终点
- Percentage of Participants With Adverse Events (AEs): Overall Summary
研究概览
简要总结
This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and non-pregnant or nursing female patients >=18 years of age;
- •body weight <=150kg;
- •moderate to severe active RA (DAS28 >=3.2) of >=6 months duration;
- •on >=1 non-biologic DMARDs at a stable dose for a period of >= 8 weeks prior to start of treatment;
- •inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy;
- •if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.
排除标准
- •major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;
- •rheumatic autoimmune disease other than RA;
- •prior history of, or current inflammatory joint disease other than RA;
- •functional class IV as defined by the ACR Classification of Functional Status in RA.
研究组 & 干预措施
1
Experimental
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs): Overall Summary
时间窗: Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with AEs, serious AEs (SAEs), related AEs, related SAEs, severe AEs, with AEs leading to withdrawal or dose modification, with infection, serious infection, infusion reactions, infusion reactions during an infusion, infusion reactions within 24 hours of an infusion, major adverse cardiac event (MACE), or death.
次要结局
- Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit(Weeks 4, 8, 12, 16, 20, and 24)
- Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event(Weeks 4, 8, 12, 16, 20, and 24)
- Swollen Joint Count by Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Patient's Global Assessment of Disease Activity by Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event(Baseline,Weeks 4, 8, 12, 16, 20, and 24)
- Tender Joint Count by Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit(Weeks 4, 8, 12, 16, 20, and 24)
- DAS28 Scores by Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response(Weeks 4, 8, 12, 16, 20, and 24)
- Physician's Global Assessment of Disease Activity by Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Patient's Global Assessment of Pain by Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- C-Reactive Protein by Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Erythrocyte Sedimentation Rate by Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- HAQ-DI Scores by Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
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