Effect of Anti CD20 in Pemphigus Desease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00213512
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: University Hospital, Rouen
• Public title: Effect of Anti CD20 in Pemphigus Desease
• Scientific title: Traitment of Patients Presenting Pemphigus With Anti CD20 (Mabthera).
• Date of first enrolment: June 2003
• Target sample size: 22
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00213512
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Contacts

• Name: pascal Joly, MD-PHD
• Affiliation: UH-Rouen

Key inclusion & exclusion criteria

Inclusion Criteria:

- age>18

- pemphigus corticoresistant

- pemphigus cortico dependant

- contre-indications : systémic steroids

Exclusion Criteria:

- age < 18

- cardiopathie

- pregnant woman

- absence contraception

- no consentment



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pemphigus

Intervention(s)

Drug: Mabthera

Primary Outcome(s)

primary end-point was the rate of CR three months after the last infusion of Rituximab

Secondary Outcome(s)

treatment tolerance

rate of CR during the study period

secondary end-points were :

time from the start of Rituximab to CR

number and length of time to relapses

Secondary ID(s)

2002/020/HP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors