Identification of predictive factors in synovial samples for the clinical response to TNF-alpha blockade in rheumatoid arthritis.
Completed
- Conditions
- Rheumatoid arthritis.
- Registration Number
- NL-OMON28799
- Lead Sponsor
- AMC, Division of Clinical Immunology and Rheumatology.
- Brief Summary
Ann Rheum Dis. 2007 Nov 29. [Epub ahead of print]
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 143
Inclusion Criteria
1. Men/women suffering from rheumatoid arthritis, based on the American Rheumatism Association (ARA) 1987 criteria, who failed at least one DMARD including methotrexate will be included in 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
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Primary immunohistologic outcome:<br /><br>TNF-alpha expression in synovial tissue as shown by immunohistochemistry and quantified by digital image analysis;<br /><br>2. Primairy clinical outcome:<br /><br>Clinical response at week 16 assessed using the DAS28.
- Secondary Outcome Measures
Name Time Method Secondary immunohistologic outcome:<br /><br>Analysis of the synovial cell infiltrate, and cytokines other than TNFalpha.