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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01299857
First received: February 17, 2011
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Pemphigus
Drug: Rituximab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Rate of relapse after 5 years of treatment [ Time Frame: five years ] [ Designated as safety issue: No ]
    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


Enrollment: 22
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rituximab
    375mg/m2
    Other Name: Mabthéra
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299857

Locations
France
UH-Rouen
Rouen,, Seine maritime,, France
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Damien PICARD, Doctor dermatological department
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01299857     History of Changes
Other Study ID Numbers: 2009/141/HP
Study First Received: February 17, 2011
Last Updated: September 12, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Rouen:
pemphigus
Mabthéra (R)
B lymphocytes
desmogleines

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

ClinicalTrials.gov processed this record on August 26, 2014