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

NCT00960713 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2012-10-23

No results posted yet for this study

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.

Conditions

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

Interventions

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).

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Laurent Sailler · University Hospital, Toulouse

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00960713 on ClinicalTrials.gov