The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders (RITAI)
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|ClinicalTrials.gov Identifier: NCT00960713|
Recruitment Status : Completed
First Posted : August 18, 2009
Last Update Posted : October 23, 2012
|Condition or disease||Intervention/treatment|
|Pemphigus Auto-immune Thrombocytopenic Purpura Hemolytic Auto-immune Anaemia Cold Agglutinin Disease Cryoglobulinemia||Drug: Rituximab (MABTHERA® or RITUXAN®).|
|Study Type :||Observational|
|Actual Enrollment :||35 participants|
|Official Title:||The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
The RITAI cohort
Every patient treated by rituximab off-label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (South of France) is eligible for the study, whatever the dose and planned infusions number. The enrolment is definitive when the first rituximab infusion begins. Follow-up visits are planned at months 1, 3, 6, 12 and 18 after the first infusion. At each visit, the investigators will record the adverse events that have occurred since the last visit. Serious or unexpected adverse events will be systematically monitored and declared to the Department of Pharmacology Pharmacovigilance unit and to Health Authorities (AFSSAPS). Imputability will be quoted according to the French method. A biological collection will be constituted to allow pharmaco-immunological studies.
Drug: Rituximab (MABTHERA® or RITUXAN®).
patients can be included in the study whatever the dosage used. Most patients will receive a classical 375 mg/m2 dose every week during four times (J0-J7-J14-J21).
- Occurrence of a serious adverse events [ Time Frame: Day 14, Week 6, Month 6, Month 12 and Month 18 ]
- Type, severity and frequency of all other adverse events occurring in the year following rituximab [ Time Frame: Day 14, Week 6, Month 6, Month 12 and Month 18 ]
- Factors that may influence the occurrence of infectious adverse events [ Time Frame: Day 14, Week 6, Month 6, Month 12 and Month 18 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960713
|Service de médecine interne, hôpital Purpan, place du Dr Baylac|
|Toulouse, France, 31059|
|Principal Investigator:||Laurent Sailler||University Hospital, Toulouse|