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

October 22, 2012 updated by: University Hospital, Toulouse

The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Service de médecine interne, hôpital Purpan, place du Dr Baylac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of a serious adverse events
Time Frame: Day 14, Week 6, Month 6, Month 12 and Month 18
Day 14, Week 6, Month 6, Month 12 and Month 18

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Day 14, Week 6, Month 6, Month 12 and Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Laurent Sailler, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

July 16, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (ESTIMATE)

August 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 23, 2012

Last Update Submitted That Met QC Criteria

October 22, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0816002
  • AOL 2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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