rheumatoid arthritis: observation of biologics treatment

Recruiting

• Conditions: M05; M06; Seropositive rheumatoid arthritis; Other rheumatoid arthritis

• Registration Number: DRKS00031523
• Lead Sponsor: Deutsches Rheuma-Forschungszentrum Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30000

Inclusion Criteria

Confirmed diagnosis of rheumatoid arthritis
- At least 18 years of age at inclusion
- Onset of rheumatoid arthritis after 16 years of age
- Starting new therapy with an approved bDMARD (biologic Disease Modifying Anti-Rheumatic Drug) or tsDMARD (targeted synthetic Disease Modifying Anti-Rheumatic Drug) respectively with a new csDMARD (conventional synthetic Disease Modifying Anti-Rheumatic Drug) after at least one csDMARD failure or addition of a csDMARD to an existing basic therapy

Exclusion Criteria

Patients with arthritis in the context of another autoimmune disease in the foreground, such as collagenosis or vasculitis

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigation of the long-term safety and effectiveness of new anti-rheumatic therapies in clinical practice, also in comparison to conventional synthetic DMARD therapy. For this purpose, the disease and therapy courses of patients with rheumatoid arthritis in routine rheumatological care will be documented over at least 5 years, ideally over 10 years.

Secondary Outcome Measures

Name	Time	Method
patient reported outcomes<br>health care consumption and work disability<br>drug survivale<br>comorbidity