Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab
Suiviritux
EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB
1 other identifier
interventional
22
1 country
1
Brief Summary
The purpose of this study is to study the midterm clinical evaluation, biological parameters and immune reconstitution after Rituximab treatment for Pemphigus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2011
CompletedFirst Posted
Study publicly available on registry
February 18, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedSeptember 13, 2012
September 1, 2012
Same day
February 17, 2011
September 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of relapse after 5 years of treatment
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
five years
Interventions
Eligibility Criteria
You may qualify if:
- 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)".
You may not qualify if:
- age \< 18
- no consentment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UH-Rouen
Rouen, Seine maritime,, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Damien PICARD, Doctor
dermatological department
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2011
First Posted
February 18, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2012
Last Updated
September 13, 2012
Record last verified: 2012-09