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Effect of Anti CD20 in Pemphigus Desease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213512
First Posted: September 21, 2005
Last Update Posted: June 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
  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: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: June 18, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents