Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid (Rituximab2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00525616
First received: July 20, 2007
Last updated: October 9, 2012
Last verified: October 2012

July 20, 2007
October 9, 2012
December 2008
December 2012   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00525616 on ClinicalTrials.gov Archive Site
Adverse reactions will be estimated during all the period of this clinical trial [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
adverse reactions will be estimated during all the period of this clinical trial [ Time Frame: 3 years ]
Not Provided
Not Provided
 
Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid
Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.

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.

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.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bullous Pemphigoid
Drug: Mabthera
Two IV perfusions of 1000mg at 15 days intervals
Experimental: Rituximab
Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid .
Intervention: Drug: Mabthera
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
June 2014
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age >= 18 and < 80
  • karnofsky >= 50%
  • bullous pemphigoid clinical indication
  • cortico-dependent bullous pemphigoid in relapse for the second time
  • contraception used in female patient
  • consent obtained from patient

Exclusion Criteria:

  • localized bullous pemphigoid in relapse (<400cm2)
  • pemphigoid of pregnancy
  • dermatosis with IgA
  • pemphigoid with mucous damage
  • pregnant woman or nursing mother
  • woman able to have a baby and without contraception during the clinical trial period
  • age < 18 or > 80
  • karnovsky < 50%
  • significant disease or uncontrolled disease
  • serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody
  • patient with depletion lymphocytic treatment or with initial rituximab treatment
  • unstable angina or ischemic heart disease
  • cardiac insufficiency
  • cardiac rhythm trouble uncontrolled
  • evolutive infection
  • immunodepression
  • neutrophil polynuclear in blood < 1.5 G/l and /or platelet blood concentration < 75G/l
  • positive HIV serology
  • positive hepatitis B and / or C serology
  • concomitant immunodepressor treatment able to induce depletion lymphocytic treatment
  • no consentment
  • antecedent of serious chronic or recurrent infection or other underlying pathology able to induce serious infection
  • antecedent of deep tissue infection occurred the previous year of inclusion
Both
18 Years to 80 Years
No
Contact: Pascal JOLY, MD-PHD 02 32 88 89 90 pascal.joly@chu-rouen.fr
Contact: Philippe MUSETTE, MD-PHD 02 32 88 89 90 philippe.musette@chu-rouen.fr
France
 
NCT00525616
2006/101/HP
No
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Pascal JOLY, MD-PHD Clinique Dermatologique - Hôpital Charles Nicolle
University Hospital, Rouen
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP