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Effect of Anti CD20 in Pemphigus Desease

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ClinicalTrials.gov Identifier: NCT00213512
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 18, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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

Condition or disease Intervention/treatment Phase
Pemphigus Drug: Mabthera Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 22 participants
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).
Study Start Date : June 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus
Drug Information available for: Rituximab
U.S. FDA Resources




Primary Outcome Measures :
  1. primary end-point was the rate of CR three months after the last infusion of Rituximab

Secondary Outcome Measures :
  1. secondary end-points were :
  2. rate of CR during the study period
  3. time from the start of Rituximab to CR
  4. number and length of time to relapses
  5. treatment tolerance


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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

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

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 Posted: September 21, 2005    Key Record Dates
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