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Effect of Anti CD20 in Pemphigus Desease

Primary Purpose

Pemphigus

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Mabthera

About this trial

This is an interventional health services research trial for Pemphigus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age>18 pemphigus corticoresistant pemphigus cortico dependant contre-indications : systémic steroids Exclusion Criteria: age < 18 cardiopathie pregnant woman absence contraception no consentment

Sites / Locations

UH-Rouen

Outcomes

Primary Outcome Measures

primary end-point was the rate of CR three months after the last infusion of Rituximab

Secondary Outcome Measures

secondary end-points were :

rate of CR during the study period

time from the start of Rituximab to CR

number and length of time to relapses

treatment tolerance

Full Information

NCT ID

NCT00213512

First Posted

September 13, 2005

Last Updated

June 17, 2013

Sponsor

University Hospital, Rouen

1. Study Identification

Unique Protocol Identification Number

NCT00213512

Brief Title

Effect of Anti CD20 in Pemphigus Desease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

June 2003 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Rouen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pemphigus

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

22 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Mabthera

Primary Outcome Measure Information:

Title

primary end-point was the rate of CR three months after the last infusion of Rituximab

Secondary Outcome Measure Information:

Title

secondary end-points were :

Title

rate of CR during the study period

Title

time from the start of Rituximab to CR

Title

number and length of time to relapses

Title

treatment tolerance

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

pascal Joly, MD-PHD

Organizational Affiliation

UH-Rouen

Official's Role

Principal Investigator

Facility Information:

Facility Name

UH-Rouen

City

Rouen

State/Province

Seine maritime

ZIP/Postal Code

76000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

17687130

Citation

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.

Results Reference

derived

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Effect of Anti CD20 in Pemphigus Desease

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