Effect of Anti CD20 in Pemphigus Desease

NCT ID: NCT00213512

Last Updated: 2013-06-18

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

PHASE2/PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2008-10-31

Brief Summary

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

Detailed Description

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Conditions

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Pemphigus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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Mabthera

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age\>18
* pemphigus corticoresistant
* pemphigus cortico dependant
* contre-indications : systémic steroids

Exclusion Criteria

* age \< 18
* cardiopathie
* pregnant woman
* absence contraception
* 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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pascal Joly, MD-PHD

Role: PRINCIPAL_INVESTIGATOR

UH-Rouen

Locations

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UH-Rouen

Rouen, Seine maritime, France

Site Status

Countries

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France

References

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Joly P, Mouquet H, Roujeau JC, D'Incan M, Gilbert D, Jacquot S, Gougeon ML, Bedane C, Muller R, Dreno B, Doutre MS, Delaporte E, Pauwels C, Franck N, Caux F, Picard C, Tancrede-Bohin E, Bernard P, Tron F, Hertl M, Musette P. A single cycle of rituximab for the treatment of severe pemphigus. N Engl J Med. 2007 Aug 9;357(6):545-52. doi: 10.1056/NEJMoa067752.

Reference Type DERIVED
PMID: 17687130 (View on PubMed)

Other Identifiers

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2002/020/HP

Identifier Type: -

Identifier Source: org_study_id

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