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

A Prospective, Multi-center, Non-interventional Observational Study to Evaluate the Safety and Effectiveness of MabThera® (Rituximab) Within the First 6 Months (in Case of Re-therapy the First 12 Months) of Treatment in Patients With Severe Active Rheumatoid Arthritis in Routine Care

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).

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