Comparison of risk and patient-related benefit of treatment with etanercept in elderly patients with rheumatoid arthritis
- Conditions
- M06.99
- Registration Number
- DRKS00012590
- Lead Sponsor
- Charité - Universitätsmedizin BerlinKlinik mS Rheumatologie und Klinische Immunologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 85
Inclusion Criteria
• Fulfilling of the DGRh criteria of treatment with ETA and/or DMARD or just begun (= 4 weeks)
• The Diagnose of a Rheumatoid Arthritis according to ACR criteria from 1987
• = 60 years
• Understanding the research project
• Signing the informed consent form
Exclusion Criteria
• DGRh-criteria to start a therapy with biologicals are not fulfilled
• There is an intra-articular injection with Glucocorticoids or other NSAIDs four weeks before screening
• There is an intramuscular injection with Glucocorticoids (>10 mg prednisolone or equivalent) or other NSAIDs four weeks before screening
• There is no signed inform consent
• Other contraindication against the participation
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the evaluation of the long term effects in the treatment with ETA (mono therapy and in combination) in quality of life, fatigue, quality of sleep in elderly patients with a RA.<br>The results will be evaluated with questionnaires in month 6 and 12 under the treatment.<br>
- Secondary Outcome Measures
Name Time Method • Change in food habits from T0 to T1 and T2<br>• change in disease activity by DAS28 and CDAI from T0 to T1 and T2<br>• change in functional capacity (HAQ) from T0 to T1 and T2<br>• change in emotional state from T0 to T1 and T2<br>• change in pain (pain detect) and visual analogue scale from T0 to T1 and T2<br>• change in ACR20, ACR50, ACR70 from T0 to T1 and T2<br>