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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00525616 |
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Date of registration:
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20/07/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid
Rituximab2 |
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Scientific title:
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Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid. |
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Date of first enrolment:
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December 2008 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00525616 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Pascal JOLY, MD-PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinique Dermatologique - Hôpital Charles Nicolle |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bullous Pemphigoid
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Intervention(s)
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Drug: Mabthera
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Primary Outcome(s)
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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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Secondary Outcome(s)
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Adverse reactions will be estimated during all the period of this clinical trial
[Time Frame: 3 years]
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Secondary ID(s)
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2006/101/HP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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