Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid
- Registration Number
- NCT00525616
- Lead Sponsor
- University Hospital, Rouen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rituximab Mabthera Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid .
- Primary Outcome Measures
Name Time Method 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
Name Time Method Adverse reactions will be estimated during all the period of this clinical trial 3 years
Trial Locations
- Locations (1)
Rouen University Hospital, Direction de la Recherche et de l'Innovation,
🇫🇷Rouen, France