NCT00960713

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

The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pemphigus
• Auto-immune Thrombocytopenic Purpura
• Hemolytic Auto-immune Anaemia
• Cold Agglutinin Disease
• Cryoglobulinemia

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2009-08-18
• Last updated: 2012-10-23

Locations

1 site across 1 country: France