ISRCTN55552928已完成未知
Combination therapy with rheumatoid arthritis (COBRA)-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to treatment strategies for rheumatoid arthritis (BeSt) in early rheumatoid arthritis
Vrije University Medical Centre (VUMC) (The Netherlands)0 个研究点目标入组 160 人开始时间: 2008年3月31日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 160
研究概览
简要总结
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/24818633 2016 results in http://www.ncbi.nlm.nih.gov/pubmed/27247434 2020 results in https://pubmed.ncbi.nlm.nih.gov/32940699/ (added 21/09/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Active RA according to American College of Rheumatology (ACR) criteria
- •2. Greater than six swollen joints or greater than six painful joints
- •3. Disease duration less than two years
- •4. Erythrocyte sedimentation rate (ESR) greater than 28 mm
- •5. Visual analogue scale (VAS) greater than 20
- •6. Age greater than 18 years, either sex
排除标准
- •1. Prior treatment DMARDs (except hydroxychloroquine)
- •2. Insulin-dependent diabetes mellitus
- •3. Uncontrollable non-insulin dependent diabetes mellitus
- •4. Heart failure New York Heart Association (NYHA) class 3 - 4
- •5. Uncontrollable hypertension
- •6. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) greater than three times normal values
- •7. Reduced renal function (serum creatinine greater than 15 mcmol)
- •8. Contra-indications for methotrexate, sulphasalazine or prednisolone
- •9. Indications of probable tuberculosis
研究者
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