NL-OMON47003
已完成
不适用
Synovial Tissue characteristics in Rheumatoid Arthritis patients TreAted with their FIrst Tnf-inhibitor - STRATAFIT
niversitair Medisch Centrum Utrecht0 个研究点目标入组 50 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- niversitair Medisch Centrum Utrecht
- 入组人数
- 50
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\* Age \* 18 years
- •\* Fulfilling 2010 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for RA (Appendix A).
- •\* DAS28 \* 3\.2
- •\* At least one clinically active wrist or knee or MCP joint
- •\* Start with aTNFi (all currently approved TNFi are allowed\* infliximab (3 mg/kg at week 0, 2, 6 and 14\), etanercept, adalimumab, golimumab, certolizumab pegol) within 4 weeks from the baseline study visit.
- •\* Having insufficient response to treatment with \* 2 conventional DMARDs.
- •\* Current treatment with either methotrexate (\*10 mg/week), sulfasalazine (\*2000 mg/day), hydroxychloroquine (\*200 mg/day), and/or leflunomide (\*10 mg/day).
- •\* Naïve to previous biological treatment regimens, including other TNFi, rituximab, abatacept, tocilizumab (and biosimilar equivalents).
排除标准
- •\* Treatment with systemic glucocorticoids at a dose above 10 mg/day of prednisone or equivalent within 4 weeks of enrolment.
- •\* Treatment with intra\-articular glucocorticoids in a knee or wrist or MCP joint within 3 months of enrolment.
- •\* Any rheumatic disease other than RA (except secondary Sjogren\*s syndrome)
结局指标
主要结局
未指定
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