NCT01000441已完成4 期
Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
University Hospital, Strasbourg, France44 个研究点 分布在 2 个国家目标入组 300 人开始时间: 2009年12月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 44
- 主要终点
- Proportion of EULAR responders
研究概览
简要总结
Approximately 30% of patients with rheumatoid arthritis have an inadequate response to anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second anti-TNF or change of biologic, with a different mechanism of action, such as abatacept, rituximab and tocilizumab. No controlled trial compared these two strategies face to face. The present objective is to investigate the issue whether one of these strategies could have a better efficacy in a pragmatic trial in the setting of current practice.
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
- •Active and erosive rheumatoid arthritis with a DAS28 equal or greater than 3.2
- •Inadequate response to a 1st anti-TNF
- •Stable or no treatment with any DMARDs, or oral corticosteroids (< or = to 10 mg/day of prednisone equivalent)during the preceding month
排除标准
- •Counter-indication to other anti-TNF, abatacept, rituximab or tocilizumab
- •Pregnancy
- •Age < 18 years
- •Impossibility to give informed consent
- •Impossibility to be followed for 12 months
研究组 & 干预措施
arm 1 (2d anti-TNF):
Active Comparator
infliximab, etanercept, adalimumab
干预措施: infliximab, etanercept, adalimumab (Drug)
arm 2 (other biotherapy)
Active Comparator
abatacept, rituximab or tocilizumab
干预措施: abatacept, rituximab or tocilizumab (Drug)
结局指标
主要结局
Proportion of EULAR responders
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (44)
Loading locations...
相似试验
进行中（未招募）
1 期
Rotation or Change of Biotherapy After TNF blocker treatment failureaxial SpondyloarthritisMedDRA version: 20.0 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2017-004700-22-FRCHU SAINT-Etienne
终止
4 期
Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)Rheumatoid ArthritisNCT00796705National Institute of Allergy and Infectious Diseases (NIAID)13
已完成
4 期
Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial SpondyloarthritisAxial SpondyloarthritisNCT03445845Centre Hospitalier Universitaire de Saint Etienne300
Unknown
4 期
Addition of Azathioprine in IBD Patients With Immunogenic FailureClinical Failure After SwitchNCT03580876Védrines, Philippe, M.D.90
已完成
不适用
BIOTIPRA: BIOmarker-guided Treatment Decisions In Psoriatic and Rheumatoid ArthritisArthritis, RheumatoidNCT03853395University of Manchester52