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OpenTrials
Completed

NCT Number: NCT00213512

Effect of Anti CD20 in Pemphigus Desease

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

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Key information

Conditions

Pemphigus Autoimmune Diseases Immune System Diseases Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

UH-Rouen

Rouen, Seine maritime, 76000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • age < 18
  • cardiopathie
  • pregnant woman
  • absence contraception
  • no consentment

Treatment and study plan

Mabthera

Drug

Primary outcomes

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

Secondary outcomes

  1. secondary end-points were :

  2. rate of CR during the study period

  3. time from the start of Rituximab to CR

  4. number and length of time to relapses

  5. treatment tolerance

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Jun 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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