Effect of Anti CD20 in Pemphigus Desease

This study is ongoing, but not recruiting participants.

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

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
Estimated Study Completion Date:	July 2007

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

Publications indexed to this study:

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.

Study ID Numbers:	2002/020/HP
Study First Received:	September 13, 2005
Last Updated:	April 2, 2007
ClinicalTrials.gov Identifier:	NCT00213512
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Autoimmune Diseases
Skin Diseases, Vesiculobullous
Skin Diseases
Rituximab
Pemphigus

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009