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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01299857
• Date of registration: 17/02/2011
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Rouen
• Public title: Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab Suiviritux
• Scientific title: EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB
• Date of first enrolment: June 2011
• Target sample size: 22
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01299857
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Damien PICARD, Doctor
• Affiliation: dermatological department

Key inclusion & exclusion criteria

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



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

Health Condition(s) or Problem(s) studied

Pemphigus

Intervention(s)

Drug: Rituximab

Primary Outcome(s)

Rate of relapse after 5 years of treatment [Time Frame: five years]

Secondary ID(s)

2009/141/HP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors