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

Completed

• Conditions: Hemolytic Auto-immune Anaemia; Auto-immune Thrombocytopenic Purpura; Pemphigus; Cold Agglutinin Disease; Cryoglobulinemia
• Interventions: Drug: Rituximab (MABTHERA® or RITUXAN®).

• Registration Number: NCT00960713
• Lead Sponsor: University Hospital, Toulouse

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 planned infusions. The enrollment is definitive at the time 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 Pharmacovigilance. Imputability will be quoted according to the French method. A biological collection will be constituted to allow pharmaco- immunological studies.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-08-17
• Study First Posted: 2009-08-18
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-22
• Last Update Posted: 2012-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The RITAI cohort	Rituximab (MABTHERA® or RITUXAN®).	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of a serious adverse events	Day 14, Week 6, Month 6, Month 12 and Month 18

Secondary Outcome Measures

Name	Time	Method
Type, severity and frequency of all other adverse events occurring in the year following rituximab	Day 14, Week 6, Month 6, Month 12 and Month 18
Factors that may influence the occurrence of infectious adverse events	Day 14, Week 6, Month 6, Month 12 and Month 18

Trial Locations

Locations (1)

Service de médecine interne, hôpital Purpan, place du Dr Baylac; 🇫🇷 Toulouse, France