The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for various auto-immune diseases.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Age over 18 years

• rituximab is prescribed off-label for an auto-immune disorder

• rituximab prescription is validated by an institutional board

• Patients have given their informed consent to be included in the cohort

Exclusion Criteria:

• Follow-up for 6 months presumably doubtful

• Rituximab is prescribed for rheumatoïd arthritis

• Rituximab is prescribed for lymphoma

• Pregnant or breath feeding women