Clinical trial NCT00525616: Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid
Official title: Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bullous Pemphigoid
Keywords: bullous pemphigoid
mabthera
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2007-09-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Adverse reactions will be estimated during all the period of this clinical trial
timeFrame: 3 years
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital, Direction de la Recherche et de l'Innovation,
Study officials:
affiliation: Clinique Dermatologique - Hôpital Charles Nicolle
name: Pascal JOLY, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References: