Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid (Rituximab2)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.|
- 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 ] [ Designated as safety issue: Yes ]
- Adverse reactions will be estimated during all the period of this clinical trial [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525616
|Contact: Pascal JOLY, MD-PHD||02 32 88 89 email@example.com|
|Contact: Philippe MUSETTE, MD-PHD||02 32 88 89 firstname.lastname@example.org|
|Rouen University Hospital, Direction de la Recherche et de l'Innovation,||Recruiting|
|Rouen, France, 76031|
|Contact: François TEILLARD 02 32 88 82 65 Delegation.Recherche@chu-rouen.fr|
|Contact: vincent FERRANTI 02 32 88 82 65 email@example.com|
|Sub-Investigator: Anne-Bénédicte DUVAL-MODESTE, MD|
|Principal Investigator:||Pascal JOLY, MD-PHD||Clinique Dermatologique - Hôpital Charles Nicolle|