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

Toulouse University Hospital

Status: Completed

Conditions: Cold Agglutinin Disease; Auto-immune Thrombocytopenic Purpura; Cryoglobulinemia; Hemolytic Auto-immune Anaemia; Pemphigus

Treatments: Drug: Rituximab (MABTHERA® or RITUXAN®).

Study type: Observational

Funder types: Other

Identifiers

NCT00960713

AOL 2008

0816002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 1 patient group

The RITAI cohort

Description:

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.

Treatment:

Drug: Rituximab (MABTHERA® or RITUXAN®).