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

NCT ID: NCT01299857

Last Updated: 2012-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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Conditions

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Pemphigus

Keywords

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pemphigus Mabthéra (R) B lymphocytes desmogleines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Rituximab

375mg/m2

Intervention Type DRUG

Other Intervention Names

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Mabthéra

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Damien PICARD, Doctor

Role: PRINCIPAL_INVESTIGATOR

dermatological department

Locations

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UH-Rouen

Rouen, Seine maritime,, France

Site Status

Countries

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France

Other Identifiers

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2009/141/HP

Identifier Type: -

Identifier Source: org_study_id