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

Primary Purpose

Bullous Pemphigoid

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Mabthera
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bullous Pemphigoid focused on measuring bullous pemphigoid, mabthera

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rouen University Hospital, Direction de la Recherche et de l'Innovation,

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab

Arm Description

Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid .

Outcomes

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.

Secondary Outcome Measures

Adverse reactions will be estimated during all the period of this clinical trial

Full Information

First Posted
July 20, 2007
Last Updated
September 5, 2014
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT00525616
Brief Title
Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid
Acronym
Rituximab2
Official Title
Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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 : 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bullous Pemphigoid
Keywords
bullous pemphigoid, mabthera

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab
Arm Type
Experimental
Arm Description
Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid .
Intervention Type
Drug
Intervention Name(s)
Mabthera
Intervention Description
Two IV perfusions of 1000mg at 15 days intervals
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Adverse reactions will be estimated during all the period of this clinical trial
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal JOLY, MD-PHD
Organizational Affiliation
Clinique Dermatologique - Hôpital Charles Nicolle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital, Direction de la Recherche et de l'Innovation,
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

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Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid

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