Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Rouen
• Treatments: Rituximab

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