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

Pemphigus Clinical Trial

— RITAI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960713
• Other study ID #: 0816002
• Secondary ID: AOL 2008
• Status: Completed
• Phase: N/A
• First received: July 16, 2009
• Last updated: October 22, 2012
• Start date: June 2009
• Est. completion date: January 2012

Study information

• Verified date: October 2012
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia, Hemolytic, Autoimmune
• Auto-immune Thrombocytopenic Purpura
• Autoimmune Diseases
• Cold Agglutinin Disease
• Cryoglobulinemia
• Hemolytic Auto-immune Anaemia
• Immune System Diseases
• Pemphigus
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

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).

Locations

Country	Name	City	State
France	Service de médecine interne, hôpital Purpan, place du Dr Baylac	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of a serious adverse events		Day 14, Week 6, Month 6, Month 12 and Month 18	Yes
Secondary	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	Yes
Secondary	Factors that may influence the occurrence of infectious adverse events		Day 14, Week 6, Month 6, Month 12 and Month 18	Yes