Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Change in disease activity.
研究概览
简要总结
The principal aim of this study is to fill a clear knowledge gap and provide guidance for rheumatologists and reassurance to the patient group on a management challenge faced daily in rheumatology practice. Specifically, it aims to provide robust evidence on the optimal management of patients with established RA that have failed an anti-TNF therapy (the first of the biological therapies to be introduced); in particular, the investigators wish to address whether the currently licensed but non NICE-approved treatment options, TNF-blocking drug or abatacept, are equivalent to the NICE-approved treatment, rituximab. If so, the intention is to broaden treatment options and target these specific therapies to disease sub-groups.
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
- 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
TNF-blocking drug
干预措施: Etanercept (Drug)
TNF-blocking drug
干预措施: Adalimumab (Drug)
TNF-blocking drug
干预措施: Certolizumab Pegol (Drug)
TNF-blocking drug
干预措施: Infliximab (Drug)
TNF-blocking drug
干预措施: Golimumab (Drug)
Abatacept
干预措施: Abatacept (Drug)
Rituximab
干预措施: Rituximab (Biological)
结局指标
主要结局
Change in disease activity.
时间窗: 6 months
Change in Disease Activity Score 28 (DAS28) at 6 months (24 weeks).
次要结局
- Reduction in disease activity.(Baseline and weeks 12, 24, 36 & 48.)
- CDAI (Clinical disease activity index)(Baseline and weeks 12, 24, 36 & 48.)
- SDAI (Simplified Disease Activity Index)(Baseline and weeks 12, 24, 36 & 48.)
- ACR/EULAR Boolean remission rates(Baseline and weeks 12, 24, 36 & 48.)
- Economic Evaluation(Baseline & weeks 12, 24, 36 & 48)
- EULAR & ACR Response Scores(Baseline and weeks 12, 24, 36, 48)
- Imaging (at the discretion of individual sites)(Baseline and week 48.)
- Quality of Life Assessments(Baseline & weeks 12, 24, 36 & 48.)
- Safety & Toxicity(Baseline and weeks 12, 24, 36 & 48.)
研究者
Julia Brown
Director of Leeds Institute of Clinical Trials Research
University of Leeds