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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Drug: Rituximab (MABTHERA® or RITUXAN®).


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The RITAI cohort<br>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®).<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of a serious adverse events |  | Day 14, Week 6, Month 6, Month 12 and Month 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
observational cohort, rituximab, off-label use, auto-immunity, cytopenia