The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders (RITAI)
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| ClinicalTrials.gov Identifier: NCT00960713 |
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Recruitment Status :
Completed
First Posted : August 18, 2009
Last Update Posted : October 23, 2012
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Sponsor:
University Hospital, Toulouse
Information provided by (Responsible Party):
University Hospital, Toulouse
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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 |
|---|---|
| Pemphigus Auto-immune Thrombocytopenic Purpura Hemolytic Auto-immune Anaemia Cold Agglutinin Disease Cryoglobulinemia | Drug: Rituximab (MABTHERA® or RITUXAN®). |
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 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 : | June 2009 |
| Actual Primary Completion Date : | January 2012 |
| Actual Study Completion Date : | January 2012 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Rituximab
| Group/Cohort | Intervention/treatment |
|---|---|
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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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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). |
Primary Outcome Measures :
- Occurrence of a serious adverse events [ Time Frame: 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 [ Time Frame: Day 14, Week 6, Month 6, Month 12 and Month 18 ]
- Factors that may influence the occurrence of infectious adverse events [ Time Frame: Day 14, Week 6, Month 6, Month 12 and Month 18 ]
Biospecimen Retention: Samples With DNA
A biological collection will be constituted to allow pharmaco- immunological studies.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960713
Locations
| France | |
| Service de médecine interne, hôpital Purpan, place du Dr Baylac | |
| Toulouse, France, 31059 | |
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
| Principal Investigator: | Laurent Sailler | University Hospital, Toulouse |
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT00960713 |
| Other Study ID Numbers: |
0816002 AOL 2008 |
| First Posted: | August 18, 2009 Key Record Dates |
| Last Update Posted: | October 23, 2012 |
| Last Verified: | October 2012 |
Keywords provided by University Hospital, Toulouse:
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observational cohort rituximab off-label use auto-immunity cytopenia |
Additional relevant MeSH terms:
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Cryoglobulinemia Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Anemia, Hemolytic, Autoimmune Pemphigus Immune System Diseases Autoimmune Diseases Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Thrombotic Microangiopathies Thrombocytopenia |
Blood Platelet Disorders Skin Diseases, Vesiculobullous Skin Diseases Hemorrhagic Disorders Anemia, Hemolytic Anemia Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Immunoproliferative Disorders Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents |