COBRA treat-to-target trial
- Conditions
- Patients with early rheumatoid arthritis
- Registration Number
- NL-OMON19866
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 190
Inclusion Criteria
1) RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR)
2) Age of 18 years and older
Exclusion Criteria
- Prior treatment DMARDs (except hydroxychloroquine)
- Insulin-dependent Diabetes mellitus
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the difference in disease activity in the two randomisation arms of both groups, measured by the percentage of patients that reach an EULAR good response at 26 weeks. EULAR good response is reached when the DAS44-score is ≤2.4 and has improved ≥1.2 points compared to baseline.
- Secondary Outcome Measures
Name Time Method The secondary outcomes are functional ability, remission, radiological progression, and patient reported outcomes. Clinical lab, bone mineral density, body composition, social demographic parameters, and lifestyle factors are tertiary parameters.