Clinical Trial: Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.

Brief Summary: The aim of the study is to assess that it will be possible to control with a single cycle of rituximab patient with bullous pemphigoid.

Detailed Summary:

The objective of this study is to assess the efficacy and tolerance of a single cycle of rituximab in control of bullous pemphigoid.

the main objects are :

  1. to assess that a single cycle of rituximab is able to control patient with corticosteroid-dependent bullous pemphigoid,
  2. to avoid the use of corticosteroid in long time,
  3. to evaluate duration of control disease and side effect with a single cycle of rituximab.

Sponsor: University Hospital, Rouen

Current Primary Outcome: Clinical and biological controls of bullous pemphigoid were estimated every seven days during a period of 1 month and every month during a period of 2 years. [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse reactions will be estimated during all the period of this clinical trial [ Time Frame: 3 years ]

Original Secondary Outcome: Same as current

Information By: University Hospital, Rouen

Dates:
Date Received: July 20, 2007
Date Started: December 2008
Date Completion:
Last Updated: September 5, 2014
Last Verified: September 2014