An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This prospective observational study aims to evaluate safety, application and onset of effect of rituximab in clinical routine treatment of severe active rheumatoid arthritis during the first 6 months (in case of re-therapy: 12 months).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• No pretreatment with rituximab

• Age 18 years or older

• Patients with active, severe rheumatoid arthritis with prescription of rituximab according to German Summary of Product Characteristics (SmPC - "Fachinformation")

• Patients with signed informed consent

• Female patients with secure contraception

Exclusion Criteria:

• Violation of Selection criteria:

1. Active severe infection

2. Severe heart failure (NYHA class IV) or severe, uncontrollable heart disease

3. Participation in an interventional study within the last 3 months before therapy start with rituximab

4. Pretreatment with rituximab

5. Age <18 years

6. Known intolerability of monoclonal antibodies or chimeric monoclonal antibodies

7. Known pregnancy or breastfeeding

• Data of patients without approval of data by the physician

• Patients without informed consent

• Double documentation