Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab

Phase 3

Completed

• Conditions: Pemphigus

• Registration Number: NCT01299857
• Lead Sponsor: University Hospital, Rouen

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Study Start: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2012-06
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-12
• Last Update Posted: 2012-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• age>18
• consentment
• patient treated with Rituximab and included in clinical trial n°2002/020/HP - NCT00213512 "Treatment of Patients Presenting Pemphigus With Anti CD20 (Mabthera)".

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Exclusion Criteria

• age < 18
• no consentment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of relapse after 5 years of treatment	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

Trial Locations

Locations (1)

UH-Rouen; 🇫🇷 Rouen,, Seine maritime,, France