A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTX
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 776
- 试验地点
- 257
- 主要终点
- Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24
研究概览
简要总结
Primary Objective:
To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).
Secondary Objectives:
To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX.
To assess the quality of life of participants with RA taking sarilumab in combination with MTX.
To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.
详细描述
The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the randomized phase of main study was 54 weeks:
- open label screening period of up to 4 weeks
- open-label treatment period of 16 weeks
- randomized screening period of 2 to 4 weeks
- randomized treatment post-treatment safety follow-up period of 6 weeks.
The maximum study duration per participant enrolled only in the open label run-in phase and was not eligible to enroll in the randomized phase of main study was 26 weeks:
- open label screening period of up to 4 weeks
- open-label treatment period of 16 weeks
- open label treatment post-treatment safety follow-up period of 6 weeks.
The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the sarilumab sub-study was 82 weeks:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Adalimumab Open Label run-in
Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX.
干预措施: Methotrexate (Drug)
Adalimumab Open Label run-in
Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX.
干预措施: Adalimumab (Drug)
Etanercept + MTX (Randomized)
Etanercept 50 mg in combination with Placebo for sarilumab Q2W and etanercept 50 mg on alternating weeks for 24 weeks added to stable dose of MTX.
干预措施: Etanercept (Drug)
Etanercept + MTX (Randomized)
Etanercept 50 mg in combination with Placebo for sarilumab Q2W and etanercept 50 mg on alternating weeks for 24 weeks added to stable dose of MTX.
干预措施: Methotrexate (Drug)
Etanercept + MTX (Randomized)
Etanercept 50 mg in combination with Placebo for sarilumab Q2W and etanercept 50 mg on alternating weeks for 24 weeks added to stable dose of MTX.
干预措施: Placebo (for sarilumab) (Drug)
Sarilumab 150 mg + MTX (Randomized)
Sarilumab 150 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
干预措施: Sarilumab (Drug)
Sarilumab 150 mg + MTX (Randomized)
Sarilumab 150 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
干预措施: Methotrexate (Drug)
Sarilumab 150 mg + MTX (Randomized)
Sarilumab 150 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
干预措施: Placebo (for etanercept) (Drug)
Sarilumab 200 mg + MTX (Randomized)
Sarilumab 200 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
干预措施: Sarilumab (Drug)
Sarilumab 200 mg + MTX (Randomized)
Sarilumab 200 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
干预措施: Methotrexate (Drug)
Sarilumab 200 mg + MTX (Randomized)
Sarilumab 200 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
干预措施: Placebo (for etanercept) (Drug)
Sarilumab 150 mg + MTX Open Label Sub-study
Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.
干预措施: Sarilumab (Drug)
Sarilumab 150 mg + MTX Open Label Sub-study
Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24
时间窗: Baseline, Week 24
次要结局
- Number of Participants With at Least 20% Improvement in American College of Rheumatology (ACR20), at Least 50% Improvement in ACR (ACR50) and at Least 70% Improvement in ACR (ACR70) Efficacy Response Rates at Week 12 and Week 24(Week 12 and Week 24)
- Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 12 and Week 24(Week 12 and Week 24)
- Change From Baseline in DAS28-CRP Score at Week 12(Baseline, Week 12)