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

Not Applicable

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN55552928
• Lead Sponsor: Vrije University Medical Centre (VUMC) (The Netherlands)

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-31
• Study Completion: 2012-01-01
• Last Update Posted: 5 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified