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

Sponsor
University Hospital, Toulouse
Study ID
NCT00960713
Status
Completed

Conditions

  • Auto-immune Thrombocytopenic Purpura
  • Cold Agglutinin Disease
  • Cryoglobulinemia
  • Hemolytic Auto-immune Anaemia
  • Pemphigus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab (MABTHERA® or RITUXAN®). — DRUG
    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).

Study Details

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.

Key Dates

Start date
Jun 30, 2009
Status verified
Oct 2012
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

Enrollment
35 participants (actual)

Arms

  • Arm: 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.

Primary Outcome Measure

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

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