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

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Rituximab

Study type: Observational

Funder types: Industry

Identifiers

NCT01071798

ML22639

Details and patient eligibility

About

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).

Enrollment: 1,653 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,653 participants in 1 patient group

Main Analysis Set

Description:

Participants who received at least one cycle of rituximab

Treatment:

Drug: Rituximab