NCT01610791已完成3 期
A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)
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
- 121
- 主要终点
- Percentage of Participants With Adverse Events
研究概览
简要总结
This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).
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
- •Adult patients, >/= 18 years of age
- •Moderate to severe active rheumatoid arthritis (DAS28 > 3.2 at screening)
- •Inadequate response to DMARDs
- •Body weight < 150 kg
排除标准
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of enrollment
- •Rheumatic autoimmune disease other than RA
- •American College of Rheumatology (ACR) functional class IV
- •Prior history of or current inflammatory joint disease other than RA
- •Previous treatment with any biologic drug that is used in the treatment of RA
- •Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- •Pregnant or lactating women
- •Active current or history of recurrent infection, active TB within the previous 3 years, HIV infection
研究组 & 干预措施
Single Arm
Experimental
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events
时间窗: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, AEs leading to withdrawal, AEs leading to death, and treatment-related AEs.
次要结局
- Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit(Weeks 4, 8, 12, 16, 20, and 24)
- Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value(Baseline through Week 24)
- Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values(Baseline through Week 24)
- Percentage of Participants With Lipid Elevations by Study Visit(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Disease Activity Score Based on 28-Joint Count (DAS28)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants by DAS28 Response Category(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Time to Achieve Clinically Meaningful Reduction in DAS28(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving Remission (DAS28 <2.6)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Patient Assessment of of Pain (VAS)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- C-Reactive Protein (CRP)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Erythrocyte Sedimentation Rate (ESR)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria(Weeks 4, 8, 12, 16, 20, and 24)
- Swollen and Tender Joint Counts(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Health Assessment Questionnaire (HAQ)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Patient Global Assessment of Disease Activity (VAS)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Physician's Global Assessment of Disease Activity (VAS)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
研究者
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