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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00960713
First Posted: August 18, 2009
Last Update Posted: October 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Toulouse
  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:


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 ]

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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
  More Information

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00960713     History of Changes
Other Study ID Numbers: 0816002
AOL 2008
First Submitted: July 16, 2009
First Posted: August 18, 2009
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:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Pemphigus
Immune System Diseases
Anemia, Hemolytic, Autoimmune
Cryoglobulinemia
Autoimmune Diseases
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Hemorrhagic Disorders
Skin Diseases, Vesiculobullous
Skin Diseases
Anemia, Hemolytic
Anemia
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Immunoproliferative Disorders
Rituximab
Antineoplastic Agents