Trial record 6 of 9 for:
"Autoimmune hemolytic anemia"
The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders
This study has been completed.
Sponsor:
University Hospital, Toulouse
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00960713
First received: July 16, 2009
Last updated: October 22, 2012
Last verified: October 2012
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Purpose
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 | Intervention |
|---|---|
|
Pemphigus Auto-immune Thrombocytopenic Purpura Hemolytic Auto-immune Anaemia Cold Agglutinin Disease Cryoglobulinemia |
Drug: Rituximab (MABTHERA® or RITUXAN®). |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
thrombotic thrombocytopenic purpura
Drug Information available for:
Rituximab
U.S. FDA Resources
Further study details as provided by University Hospital, Toulouse:
Primary Outcome Measures:
- Occurrence of a serious adverse events [ Time Frame: Day 14, Week 6, Month 6, Month 12 and Month 18 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
- Factors that may influence the occurrence of infectious adverse events [ Time Frame: Day 14, Week 6, Month 6, Month 12 and Month 18 ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
A biological collection will be constituted to allow pharmaco- immunological studies.
| Enrollment: | 35 |
| Study Start Date: | June 2009 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT00960713 History of Changes |
| Other Study ID Numbers: | 0816002, AOL 2008 |
| Study First Received: | July 16, 2009 |
| Last Updated: | October 22, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Toulouse:
|
observational cohort rituximab off-label use auto-immunity cytopenia |
Additional relevant MeSH terms:
|
Anemia Anemia, Hemolytic, Autoimmune Autoimmune Diseases Cryoglobulinemia Immune System Diseases Pemphigus Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Hemolysis Hematologic Diseases Anemia, Hemolytic Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hemorrhagic Disorders Immunoproliferative Disorders Skin Diseases, Vesiculobullous Skin Diseases Blood Coagulation Disorders Hemorrhage Pathologic Processes Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia Blood Platelet Disorders Rituximab |
ClinicalTrials.gov processed this record on May 16, 2013