Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 试验地点
- 30
- 主要终点
- DAS28-ESR remission at 24 weeks
研究概览
简要总结
The objective of this study is to investigate the efficacy and safety of the humanized anti-human IL-6 receptor monoclonal antibody tocilizumab (TCZ) either in monotherapy or in combination therapy with methotrexate (MTX) in patients with an inadequate response to treatment with MTX.
Furthermore, in patients who have been able to achieve control of disease activity via the above therapy, we investigate the possibility of stopping TCZ and verify safety when TCZ is restarted after disease recurrence.
详细描述
In this study, we aim to prospectively and randomly evaluate efficacy for changes in clinical remission and joint destruction in RA patients in treatment with TCZ monotherapy(SWITCH) and in combination therapy with MTX(ADD-ON), and also to investigate the best therapeutic approach to achieve discontinuation.
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
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with RA in accordance with the 1987 classification criteria of ACR
- •Aged 20 to 75 years inclusive at enrolment (within 2 weeks before starting treatment with the investigational drug)
- •Treated with MTX at ≥6 mg/week for at least 8 weeks immediately before enrolment
- •Rheumatoid arthritis of duration ≤10 years
- •DAS28-ESR ≥3.2 (within 2 weeks before starting treatment with the investigational drug)
- •Having received and thoroughly understood an adequate explanation about participation in the study, patients who have personally and voluntarily provided written informed consent
- •Major exclusion criteria:
- •Patients who were Steinbrocker Class IV.
- •Patients who received leflunomide within 12 weeks, DMARDs other than MTX within 8 weeks , or tacrolimus within 4 weeks before the 1st TCZ infusion.
- •Patients who previously received biologic DMARDs including TCZ.
排除标准
- 未提供
研究组 & 干预措施
SWITCH
Tocilizumab monotherapy
干预措施: Tocilizumab (Drug)
ADD-ON
Tocilizumab plus methotrexate combination
干预措施: Tocilizumab plus methotrexate (Drug)
结局指标
主要结局
DAS28-ESR remission at 24 weeks
时间窗: at 24 week
Step 1: Investigation of the efficacy and safety of TCZ in combination therapy with MTX
Changes over time in the number of patients maintaining discontinuation (maintenance rate)
时间窗: Week 52 to Week 104
Step 2: Investigation of discontinuation
次要结局
- Change in TSS score(Week 52 to Week 104)
- Change of ACR response rate(Week 0 to Week 52)
- EQ5D scores over time(Week 0 to Week 52)
- SDAI, CDAI, and Boolean remission rates(Week 52 to Week 104)
- Between-group comparison of the discontinuation rate after an achievement of remission(Week 0 to Week 104)
- Time course of DAS28 after restarting TCZ (between-group comparison)(Week 52 to Week 104)
- Change of DAS28-ESR remission rate(Week 0 to Week 52)
- J-HAQ/HAQ scores over time(Week 0 to Week 52)
- TNF-α over time(Week 0 to Week 52)
- Factor analysis of patients maintaining discontinuation(Week 0 to Week 104)
- Time course of DAS28 after restarting MTX following suspension of discontinuation in the TCZ monotherapy group in Step 1(Week 52 to Week 104)