CTIS2022-500234-29-00招募中1 期
Efficacy of a sequential treatment strategy in Rheumatoid Arthritis. A randomized controlled trial with an independent efficacy assessor. - RECHMPL21_0568
niversity Hospital Montpellier0 个研究点目标入组 220 人开始时间: 2022年4月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Aged 18 years or above, Rheumatoid Arthritis according to ACR-EULAR 2010, ACPA positive, Under methotrexate or leflunomide treatment for at least 3 months, DAS28-CRP>3.2 under methotrexate or leflunomide calculated with CRP dated less than 7 days from baseline, Escape under synthetic background treatment defined by an elevation of CRP (CRP> 5mg/L ) or ESR (for men: > age in years/2 ; for women: > age (+10) /2)) within the last 6 months before baseline, Targeted DMARDs (biological and targeted synthetic DMARDs) naïve, Indication for a TNF inhibitor
排除标准
- •Contra-indications to a TNF inhibitor and/or Abatacept, Dementia, Fibromyalgia, Absence of tuberculosis screening in the previous 3 months before baseline, Drug addiction, addiction to alcohol, Subject with moderate to severe heart failure (class 3 or class 4 cardiac disease as defined by the New York Heart Association Functional Classification), Known allergy or intolerance to an anti-TNF therapy, Patient with untreated active hepatitis B, Patient vaccinated with a live vaccine within 30 days prior to screening
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