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

University Hospital, Rouen

Status and phase: Completed; Phase 3

Conditions: Bullous Pemphigoid

Treatments: Drug: Mabthera

Study type: Interventional

Funder types: Other

Identifiers

NCT00525616

2006/101/HP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Rituximab

Experimental group

Description:

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

Treatment:

Drug: Mabthera