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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00525616
First received: July 20, 2007
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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
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.

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 ] [ Designated as safety issue: Yes ]

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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525616

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

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00525616     History of Changes
Other Study ID Numbers: 2006/101/HP
Study First Received: July 20, 2007
Last Updated: September 5, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
bullous pemphigoid
mabthera

Additional relevant MeSH terms:
Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 14, 2014