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| ID | Type | Description | Link |
|---|---|---|---|
| AOL 2008 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab (MABTHERA® or RITUXAN®). | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of a serious adverse events | Day 14, Week 6, Month 6, Month 12 and Month 18 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Every patient treated by rituximab off -label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (in the South of France) is eligible for the study
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Sailler | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de médecine interne, hôpital Purpan, place du Dr Baylac | Toulouse | 31059 | France |
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A biological collection will be constituted to allow pharmaco- immunological studies.
| ID | Term |
|---|---|
| D010392 | Pemphigus |
| D000744 | Anemia, Hemolytic, Autoimmune |
| D003449 | Cryoglobulinemia |
| D000095542 | Cytopenia |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D017445 | Skin Diseases, Vascular |
| D007160 | Immunoproliferative Disorders |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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