- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00525616
Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid (Rituximab2)
September 5, 2014 updated by: University Hospital, Rouen
Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rouen, France, 76031
- Rouen University Hospital, Direction de la Recherche et de l'Innovation,
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rituximab
Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid .
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Two IV perfusions of 1000mg at 15 days intervals
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What is the study measuring?
Primary Outcome Measures
Outcome 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.
Time Frame: 2 years
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2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse reactions will be estimated during all the period of this clinical trial
Time Frame: 3 years
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3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pascal JOLY, MD-PHD, Clinique Dermatologique - Hôpital Charles Nicolle
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
July 20, 2007
First Submitted That Met QC Criteria
September 5, 2007
First Posted (Estimate)
September 6, 2007
Study Record Updates
Last Update Posted (Estimate)
September 8, 2014
Last Update Submitted That Met QC Criteria
September 5, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006/101/HP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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