Trial record 2 of 3 for:    "Cryoglobulinemia"

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

This study has been completed.
Sponsor:
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
  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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Cryoglobulinemia
Anemia
Anemia, Hemolytic, Autoimmune
Autoimmune Diseases
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 August 25, 2014