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Completed

NCT Number: NCT00960713

The RITAI Cohort: An Observational Study on 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.

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Key information

Conditions

Pemphigus Anemia Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Auto-immune Thrombocytopenic Purpura Autoimmune Diseases Blood Protein Disorders Cardiovascular Diseases Cold Agglutinin Disease Cryoglobulinemia Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemolytic Auto-immune Anaemia Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Paraproteinemias Skin Diseases Skin Diseases, Vascular Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de médecine interne, hôpital Purpan, place du Dr Baylac

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Occurrence of a serious adverse events

    Time frame: Day 14, Week 6, Month 6, Month 12 and Month 18

Secondary outcomes

  1. 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

  2. Factors that may influence the occurrence of infectious adverse events

    Time frame: Day 14, Week 6, Month 6, Month 12 and Month 18

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: RITAI

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 18, 2009
Registry last updated
Oct 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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