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

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

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Key information

Conditions

Pemphigus Autoimmune Diseases Immune System Diseases Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UH-Rouen

Rouen, Seine maritime,, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)".

Exclusion criteria

age < 18
no consentment

Treatment and study plan

Rituximab

Drug

375mg/m2

Other names: Mabthéra

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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: Suiviritux

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2012
First posted: Feb 18, 2011
Registry last updated: Sep 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed