Rituximab2: Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid

Sponsor

University Hospital, Rouen (Other)

Overall Status

Completed

CT.gov ID

NCT00525616

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bullous Pemphigoid	Drug: Mabthera	Phase 3

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 :

to assess that a single cycle of rituximab is able to control patient with corticosteroid-dependent bullous pemphigoid,
to avoid the use of corticosteroid in long time,
to evaluate duration of control disease and side effect with a single cycle of rituximab.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rituximab Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid .	Drug: Mabthera Two IV perfusions of 1000mg at 15 days intervals

Arm

Intervention/Treatment

Experimental: Rituximab

Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid .

Drug: Mabthera

Two IV perfusions of 1000mg at 15 days intervals

Outcome Measures

Primary Outcome Measures

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

Adverse reactions will be estimated during all the period of this clinical trial [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rouen University Hospital, Direction de la Recherche et de l'Innovation,	Rouen		France	76031

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator: Pascal JOLY, MD-PHD, Clinique Dermatologique - Hôpital Charles Nicolle

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT00525616

Other Study ID Numbers:

2006/101/HP

First Posted:

Sep 6, 2007

Last Update Posted:

Sep 8, 2014

Last Verified:

Sep 1, 2014

Keywords provided by University Hospital, Rouen

bullous pemphigoid

mabthera

Additional relevant MeSH terms:

Pemphigoid, Bullous

Rituximab

Study Results

No Results Posted as of Sep 8, 2014