Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid (Rituximab2)
This study is currently recruiting participants.
Verified October 2012 by University Hospital, Rouen
Sponsor:
University Hospital, Rouen
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00525616
First received: July 20, 2007
Last updated: October 9, 2012
Last verified: October 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Bullous Pemphigoid |
Drug: Mabthera |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Rouen:
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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Adverse reactions will be estimated during all the period of this clinical trial [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525616
Contacts
| Contact: Pascal JOLY, MD-PHD | 02 32 88 89 90 | pascal.joly@chu-rouen.fr |
| Contact: Philippe MUSETTE, MD-PHD | 02 32 88 89 90 | philippe.musette@chu-rouen.fr |
Locations
| France | |
| Rouen University Hospital, Direction de la Recherche et de l'Innovation, | Recruiting |
| Rouen, France, 76031 | |
| Contact: François TEILLARD 02 32 88 82 65 Delegation.Recherche@chu-rouen.fr | |
| Contact: vincent FERRANTI 02 32 88 82 65 vincent.ferranti@chu-rouen.fr | |
| Sub-Investigator: Anne-Bénédicte DUVAL-MODESTE, MD | |
Sponsors and Collaborators
University Hospital, Rouen
Investigators
| Principal Investigator: | Pascal JOLY, MD-PHD | Clinique Dermatologique - Hôpital Charles Nicolle |
More Information
No publications provided
| Responsible Party: | University Hospital, Rouen |
| ClinicalTrials.gov Identifier: | NCT00525616 History of Changes |
| Other Study ID Numbers: | 2006/101/HP |
| Study First Received: | July 20, 2007 |
| Last Updated: | October 9, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Rouen:
|
bullous pemphigoid mabthera |
Additional relevant MeSH terms:
|
Pemphigoid, Bullous Skin Diseases, Vesiculobullous Skin Diseases Autoimmune Diseases Immune System Diseases Rituximab |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013