Bullous Pemphigoid
Conditions
Keywords
bullous pemphigoid, mabthera
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.
Interventions
DRUGMabthera
Two IV perfusions of 1000mg at 15 days intervals
Sponsors
University Hospital, Rouen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Adverse reactions will be estimated during all the period of this clinical trial | 3 years |
Countries
France
Outcome results
None listed