EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB

University Hospital, Rouen1 site in 1 country22 target enrollmentJune 2011

ConditionsPemphigus

DrugsRituximab

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pemphigus
Sponsor: University Hospital, Rouen
Enrollment: 22
Locations: 1
Primary Endpoint: Rate of relapse after 5 years of treatment
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to study the midterm clinical evaluation, biological parameters and immune reconstitution after Rituximab treatment for Pemphigus.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

June 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Rouen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•consentment
•patient treated with Rituximab and included in clinical trial n°2002/020/HP - NCT00213512 "Treatment of Patients Presenting Pemphigus With Anti CD20 (Mabthera)".

Exclusion Criteria

•age \< 18
•no consentment

Outcomes

Primary Outcomes

Rate of relapse after 5 years of treatment

Time Frame: five years

Primary outcome measure is the evaluation of Rate of relapse after 5 years of treatment by rituximab for patient with pemphigus. The relapse is defined by the reappearance of mucous or cutaneous érosives lésions proved by histology and by direct immunofluorescence