Effect of Anti CD20 in Pemphigus Desease

Pemphigus Clinical Trial

Official title:

Traitment of Patients Presenting Pemphigus With Anti CD20 (Mabthera).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213512
• Other study ID #: 2002/020/HP
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: June 17, 2013
• Start date: June 2003
• Est. completion date: October 2008

Study information

• Verified date: June 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

to treat in an open non comparative clinical study patients presenting pemphigus with corticodependance, corticoresistance and contre-indication to systemic steroids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2008
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age>18

• pemphigus corticoresistant

• pemphigus cortico dependant

• contre-indications : systémic steroids

Exclusion Criteria:

• age < 18

• cardiopathie

• pregnant woman

• absence contraception

• no consentment

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pemphigus

Intervention

Drug:
• Mabthera

Locations

Country	Name	City	State
France	UH-Rouen	Rouen	Seine maritime

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary end-point was the rate of CR three months after the last infusion of Rituximab
Secondary	secondary end-points were :
Secondary	rate of CR during the study period
Secondary	time from the start of Rituximab to CR
Secondary	number and length of time to relapses
Secondary	treatment tolerance