Status:
COMPLETED
Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus
Lead Sponsor:
University Hospital, Rouen
Conditions:
Pemphigus Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Pemphigus is a severe and sometimes life-threatening disease with a mortality rate between 5 and 10 percent depending on the severity of disease and age of patients. The standard of care is high dose...
Eligibility Criteria
Inclusion
- age \>=18 and \<= 80years
- consent obtained from patient
- effective female contraceptive method for women in procreate age
- new case of pemphigus vulgaris (PV) or pemphigus foliaceus (PF)
Exclusion
- pemphigus vulgaris (PV) or pemphigus foliaceus (PF) treated
- pregnant woman or nursing mother
- woman able to have a baby and without contraception during the clinical trial period
- age \< 18 or \> 80
- karnovsky \< 50%
- serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody
- patient with depletion lymphocytic treatment in the next month
- unstable angina or ischemic heart disease
- cardiac insufficiency
- cardiac rhythm trouble uncontrolled
- positive HIV serology
- positive hepatitis B and / or C serology
- no consent
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00784589
Start Date
July 1 2009
End Date
December 1 2016
Last Update
June 14 2017
Active Locations (1)
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1
CHU de Rouen - Hôpitaux de Rouen
Rouen, Seine Maritime, France, 76031