Effect of Anti CD20 in Pemphigus Desease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213512
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013
  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 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)
  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
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov 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:
Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 21, 2014