ISRCTN55552928
Completed
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 sites160 target enrollmentMarch 31, 2008
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Rheumatoid arthritis
- Sponsor
- Vrije University Medical Centre (VUMC) (The Netherlands)
- Enrollment
- 160
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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