Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid (Rituximab2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00525616|
Recruitment Status : Completed
First Posted : September 6, 2007
Last Update Posted : September 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bullous Pemphigoid||Drug: Mabthera||Phase 3|
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 :
- to assess that a single cycle of rituximab is able to control patient with corticosteroid-dependent bullous pemphigoid,
- to avoid the use of corticosteroid in long time,
- to evaluate duration of control disease and side effect with a single cycle of rituximab.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.|
|Study Start Date :||December 2008|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid .
Two IV perfusions of 1000mg at 15 days intervals
- 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 ]
- Adverse reactions will be estimated during all the period of this clinical trial [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525616
|Rouen University Hospital, Direction de la Recherche et de l'Innovation,|
|Rouen, France, 76031|
|Principal Investigator:||Pascal JOLY, MD-PHD||Clinique Dermatologique - Hôpital Charles Nicolle|