Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Anti CD20 in Pemphigus Desease

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013

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

Condition Intervention Phase
Drug: Mabthera
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Traitment of Patients Presenting Pemphigus With Anti CD20 (Mabthera).

Resource links provided by NLM:

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)

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00213512

Rouen, Seine maritime, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
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 Identifier (NCT Number):
Responsible Party: University Hospital, Rouen Identifier: NCT00213512     History of Changes
Other Study ID Numbers: 2002/020/HP
Study First Received: September 13, 2005
Last Updated: June 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Skin Diseases, Vesiculobullous processed this record on November 25, 2014