Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid

Bullous Pemphigoid Clinical Trial

— Rituximab2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525616
• Other study ID #: 2006/101/HP
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2007
• Last updated: September 5, 2014
• Start date: December 2008
• Est. completion date: December 2013

Study information

• Verified date: September 2014
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bullous Pemphigoid
• Pemphigoid, Bullous

Intervention

Drug:
• Mabthera
Two IV perfusions of 1000mg at 15 days intervals

Locations

Country	Name	City	State
France	Rouen University Hospital, Direction de la Recherche et de l'Innovation,	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Adverse reactions will be estimated during all the period of this clinical trial		3 years	Yes