Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.

Conditions
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Bullous Pemphigoid

Intervention / Treatment
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* Drug: Mabthera


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab<br>Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid . | Drug: Mabthera<br>* Two IV perfusions of 1000mg at 15 days intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions will be estimated during all the period of this clinical trial |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bullous pemphigoid, mabthera