Auto-immune Thrombocytopenic Purpura, Cold Agglutinin Disease, Cryoglobulinemia, Hemolytic Auto-immune Anaemia, Pemphigus
Conditions
Keywords
observational cohort, rituximab, off-label use, auto-immunity, cytopenia
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.
Interventions
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).
Sponsors
University Hospital, Toulouse
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of a serious adverse events | Day 14, Week 6, Month 6, Month 12 and Month 18 |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed