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

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: July 20, 2007
Last updated: September 5, 2014
Last verified: September 2014
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.

Condition Intervention Phase
Bullous Pemphigoid Drug: Mabthera Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.

Resource links provided by NLM:

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 18
Study Start Date: December 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab
Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid .
Drug: Mabthera
Two IV perfusions of 1000mg at 15 days intervals

Detailed Description:

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00525616

Rouen University Hospital, Direction de la Recherche et de l'Innovation,
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Pascal JOLY, MD-PHD Clinique Dermatologique - Hôpital Charles Nicolle
  More Information

Responsible Party: University Hospital, Rouen Identifier: NCT00525616     History of Changes
Other Study ID Numbers: 2006/101/HP
Study First Received: July 20, 2007
Last Updated: September 5, 2014

Keywords provided by University Hospital, Rouen:
bullous pemphigoid

Additional relevant MeSH terms:
Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on September 21, 2017