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

NCT00960713 | Completed DMC

• 2 other identifiers: 0816002AOL 2008
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

observational cohort; rituximab; off-label use; auto-immunity; cytopenia

Outcome Measures

Primary Outcomes (1)

• Occurrence of a serious adverse events

  Day 14, Week 6, Month 6, Month 12 and Month 18

Secondary Outcomes (2)

• Type, severity and frequency of all other adverse events occurring in the year following rituximab

  Day 14, Week 6, Month 6, Month 12 and Month 18

• Factors that may influence the occurrence of infectious adverse events

  Day 14, Week 6, Month 6, Month 12 and Month 18

Study Arms (1)

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®).

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).

The RITAI cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Follow-up for 6 months presumably doubtful
• Rituximab is prescribed for rheumatoïd arthritis
• Rituximab is prescribed for lymphoma
• Pregnant or breath feeding women

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

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

Toulouse, 31059, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

A biological collection will be constituted to allow pharmaco- immunological studies.

MeSH Terms

Conditions

Pemphigus; Anemia, Hemolytic, Autoimmune; Cryoglobulinemia; Cytopenia

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Skin Diseases, Vascular; Immunoproliferative Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Laurent Sailler

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: August 18, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: October 23, 2012

Record last verified: 2012-10

Locations

FR (1)