Etanercept cohort studie.
Completed
- Conditions
- RA, Reumatoide Artritis, Rheumatoid Arthritis
- Registration Number
- NL-OMON26481
- Lead Sponsor
- Academisch Medisch Centrum Div. Immunology and Rheumatology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Patients with the diagnosis rheumatoid arthritis according to the American Rheumatism Association (ARA) 1987 criteria and in ACR 1991 functional classes I, II, and III;
2. The patient is naïve for anti-TNF-alpha therapy or has failed other prior TNF-alpha blockers;
Exclusion Criteria
1. Pregnancy;
2. Breastfeeding;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is the percentage of patients with a moderate to good response to etanercept treatment at 16 weeks according to the Eular response criteria which is also applied in routine rheumatological practice. <br /><br>Furthermore the primary endpoint of the study is to search for clinical parameters and/or serological markers that possibly distinguish responders from non-responders to TNF-α blockade by etanercept.
- Secondary Outcome Measures
Name Time Method The secundary endpoint of the study is the proportion of patients with a 20%, 50%, and 70% clinical improvement according to the ACR response criteria [13] at 4, 16, 28, 40 and 52 weeks after the initiation of etanercept treatment. The parameters of disease activity e.g. tender joint count, swollen joint count, patient’s assessment of pain, patient’s global assessment, investigators global assessment, duration of morning stiffness, health assessment questionnaire, DAS 28, SF-36 (short form health survey) and RADAI [14] will be assessed at each time point starting from baseline. <br><br /><br /><br>We will look for genetic markers, e.g. genetic polymorphisms in TNF-alpha genes, that may predict diagnosis, efficacy and side-effects of treatment in the individual patient.<br /><br>In the future micro-array analysis may be done to screen for new markers that distinguish responders from non-responders.