Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid

NCT ID: NCT00525616

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2013-12-31

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 :

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.

Conditions

Bullous Pemphigoid

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab

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

Group Type: EXPERIMENTAL

Mabthera

Intervention Type: DRUG

Two IV perfusions of 1000mg at 15 days intervals

Interventions

Mabthera

Two IV perfusions of 1000mg at 15 days intervals

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal JOLY, MD-PHD

Role: PRINCIPAL_INVESTIGATOR

Clinique Dermatologique - Hôpital Charles Nicolle

Locations

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

Rouen, , France

Countries

France

Other Identifiers

2006/101/HP

Identifier Type: -

Identifier Source: org_study_id