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

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ClinicalTrials.gov Identifier: NCT00960713
Recruitment Status : Completed
First Posted : August 18, 2009
Last Update Posted : October 23, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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®).

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.
Study Design
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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

Groups and Cohorts
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Group/Cohort Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of a serious adverse events [ Time Frame: Day 14, Week 6, Month 6, Month 12 and Month 18 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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.

Eligibility Criteria
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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
Contacts and Locations
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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
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France
Service de médecine interne, hôpital Purpan, place du Dr Baylac
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Laurent Sailler University Hospital, Toulouse
More Information
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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:
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