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Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab (Suiviritux)

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.
 
ClinicalTrials.gov Identifier: NCT01299857
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : September 13, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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Brief Summary:
The purpose of this study is to study the midterm clinical evaluation, biological parameters and immune reconstitution after Rituximab treatment for Pemphigus.

Condition or disease Intervention/treatment Phase
Pemphigus Drug: Rituximab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB
Study Start Date : June 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus
Drug Information available for: Rituximab

Arms and Interventions
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Intervention Details:
  • Drug: Rituximab
    375mg/m2
    Other Name: Mabthéra

Outcome Measures
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Primary Outcome Measures :
  1. Rate of relapse after 5 years of treatment [ Time Frame: five years ]
    Primary outcome measure is the evaluation of Rate of relapse after 5 years of treatment by rituximab for patient with pemphigus. The relapse is defined by the reappearance of mucous or cutaneous érosives lésions proved by histology and by direct immunofluorescence


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age>18
  • consentment
  • patient treated with Rituximab and included in clinical trial n°2002/020/HP - NCT00213512 "Treatment of Patients Presenting Pemphigus With Anti CD20 (Mabthera)".

Exclusion Criteria:

  • age < 18
  • no consentment
Contacts and Locations
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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): NCT01299857


Locations
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France
UH-Rouen
Rouen,, Seine maritime,, France
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Damien PICARD, Doctor dermatological department
More Information
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01299857    
Other Study ID Numbers: 2009/141/HP
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: September 13, 2012
Last Verified: September 2012
Keywords provided by University Hospital, Rouen:
pemphigus
Mabthéra (R)
B lymphocytes
desmogleines
Additional relevant MeSH terms:
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Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents