Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis.
Recruiting
- Conditions
- RAReumatoide ArtritisRheumatoid ArthritisReuma
- Registration Number
- NL-OMON22398
- Lead Sponsor
- AMC Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
1. Men/women suffering from rheumatoid arthritis, based on the American Rheumatism Association (ARA) 1987 criteria, who failed methotrexate treatment, will be eligible for the study;
2. Patients in ARA functional classes I, II, and III may be included.
Exclusion Criteria
1. Pregnancy;
2. Breastfeeding;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study changes in synovial inflammation in serial biopsy samples following administration of abatacept therapy to subjects with active rheumatoid arthritis.
- Secondary Outcome Measures
Name Time Method 1. Assess clinical response;<br /><br>2. Assess cellular responses of synovial explants to inflammatory stimuli, and/or antagonists, before and after treatment with abatacept;<br /><br>3. Identify synovial biomarkers predictive of the clinical response to abatacept treatment;<br /><br>4. Investigate the changes in phenotypes of peripheral blood mononuclear cells (PBMCs).