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

Pemphigus Clinical Trial

— Suiviritux  

Official title:

EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299857
• Other study ID #: 2009/141/HP
• Status: Completed
• Phase: Phase 3
• First received: February 17, 2011
• Last updated: September 12, 2012
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2012
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pemphigus

Intervention

Drug:
• Rituximab
375mg/m2

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	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	No