Status:
COMPLETED
The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Pemphigus
Auto-immune Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
Every patient treated by rituximab off -label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (France) is eligible for the study, whatever the dose and the number of plann...
Eligibility Criteria
Inclusion
- 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
- Follow-up for 6 months presumably doubtful
- Rituximab is prescribed for rheumatoïd arthritis
- Rituximab is prescribed for lymphoma
- Pregnant or breath feeding women
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00960713
Start Date
June 1 2009
End Date
January 1 2012
Last Update
October 23 2012
Active Locations (1)
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1
Service de médecine interne, hôpital Purpan, place du Dr Baylac
Toulouse, France, 31059