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

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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

February 17, 2011
February 18, 2011
September 13, 2012
June 2011
June 2011   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01299857 on ClinicalTrials.gov Archive Site
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Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab
EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB
The purpose of this study is to study the midterm clinical evaluation, biological parameters and immune reconstitution after Rituximab treatment for Pemphigus.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Pemphigus
Drug: Rituximab
375mg/m2
Other Name: Mabthéra
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
21
June 2012
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01299857
2009/141/HP
No
Not Provided
Not Provided
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Damien PICARD, Doctor dermatological department
University Hospital, Rouen
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP