Effect of Anti CD20 in Pemphigus Desease

This study has been completed.

First Received: September 13, 2005 Last Updated: February 12, 2009 History of Changes

Sponsored by:	University Hospital, Rouen
Information provided by:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00213512

Purpose

to treat in an open non comparative clinical study patients presenting pemphigus with corticodependance, corticoresistance and contre-indication to systemic steroids.

Condition	Intervention	Phase
Pemphigus	Drug: Mabthera	Phase II Phase III

MedlinePlus related topics: Pemphigus

Drug Information available for: Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Traitment of Patients Presenting Pemphigus With Anti CD20 (Mabthera).

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:

primary end-point was the rate of CR three months after the last infusion of Rituximab

Secondary Outcome Measures:

secondary end-points were :
rate of CR during the study period
time from the start of Rituximab to CR
number and length of time to relapses
treatment tolerance

Estimated Enrollment:	22
Study Start Date:	June 2003
Study Completion Date:	October 2008
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age>18
pemphigus corticoresistant
pemphigus cortico dependant
contre-indications : systémic steroids

Exclusion Criteria:

age < 18
cardiopathie
pregnant woman
absence contraception
no consentment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213512

Locations

France, Seine maritime
UH-Rouen
Rouen, Seine maritime, France, 76000

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:

pascal Joly, MD-PHD

UH-Rouen

More Information

No publications provided by University Hospital, Rouen

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Joly P, Mouquet H, Roujeau JC, D'Incan M, Gilbert D, Jacquot S, Gougeon ML, Bedane C, Muller R, Dreno B, Doutre MS, Delaporte E, Pauwels C, Franck N, Caux F, Picard C, Tancrede-Bohin E, Bernard P, Tron F, Hertl M, Musette P. A single cycle of rituximab for the treatment of severe pemphigus. N Engl J Med. 2007 Aug 9;357(6):545-52.

Responsible Party:	Rouen University Hospital ( PAIRE Christian / Managing Director )
Study ID Numbers:	2002/020/HP
Study First Received:	September 13, 2005
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00213512 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Autoimmune Diseases
Immunologic Factors
Skin Diseases, Vesiculobullous
Skin Diseases

Rituximab
Antirheumatic Agents
Pemphigus

Additional relevant MeSH terms:

Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Skin Diseases
Skin Diseases, Vesiculobullous
Antineoplastic Agents

Rituximab
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions
Pemphigus

ClinicalTrials.gov processed this record on May 07, 2009