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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Completed

CT.gov ID

NCT00960713

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pemphigus Auto-immune Thrombocytopenic Purpura Hemolytic Auto-immune Anaemia Cold Agglutinin Disease Cryoglobulinemia	Drug: Rituximab (MABTHERA® or RITUXAN®).

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 Design

Study Type:

Observational

Actual Enrollment :

35 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 :

Jun 1, 2009

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

Occurrence of a serious adverse events [Day 14, Week 6, Month 6, Month 12 and Month 18]

Secondary Outcome Measures

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]