CompletedNot Applicable

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

France35 participantsStarted 2009-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Occurrence of a serious adverse events

Timeframe: Day 14, Week 6, Month 6, Month 12 and Month 18

Trial details

NCT IDNCT00960713

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-01

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