EUCTR2017-004700-22-FR进行中(未招募)1 期
Rotation or Change of Biotherapy After TNF blocker treatment failure for axial Spondyloarthritis: The ROC-SpA study
CHU SAINT-Etienne0 个研究点目标入组 0 人开始时间: 2018年1月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Active axSPA with BASDAI>4 and ASDAS>3.5, who need change in TNF blocker treatment
- •Aged over 18 years
- •Inadequate response after at least 3 months to the 1st TNF blocker
- •If non biologic DMARD treatment : stable dose for at least on month before inclusion
- •If oral corticosteroids treatment : stable dose for at least on month before inclusion
- •IfNSAIDs treatment : stable dose for at least on month before inclusion
- •Ability to complete questionnaires
- •Social security affiliation
- •Informed written consent given
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Any contra-indication to TNF blocker and/or secukinumab
- •Inflammatory bowel diseases
- •Existing pregnancy, lactation, or intended pregnancy within the next 15 months Active tuberculosis or other severe infections such as sepsis or opportunistic infections
- •Active infections, including chronic or localised infections.
- •Moderate to severe heart failure (NYHA classes III/IV)
- •Impossibility to give informed consent
- •Impossibility to be followed for 12 months
研究者
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不适用
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