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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary: 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.
Sponsor: University Hospital, Toulouse

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • Factors that may influence the occurrence of infectious adverse events [ Time Frame: Day 14, Week 6, Month 6, Month 12 and Month 18 ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Toulouse

Dates:
Date Received: July 16, 2009
Date Started: June 2009
Date Completion:
Last Updated: October 22, 2012
Last Verified: October 2012