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
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 20, 2007 | ||||||||
| Last Updated Date | October 9, 2012 | ||||||||
| Start Date ICMJE | December 2008 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Change History | Complete list of historical versions of study NCT00525616 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Adverse reactions will be estimated during all the period of this clinical trial [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
adverse reactions will be estimated during all the period of this clinical trial [ Time Frame: 3 years ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid | ||||||||
| Official Title ICMJE | Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid. | ||||||||
| 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. |
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| 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 :
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Bullous Pemphigoid | ||||||||
| Intervention ICMJE | Drug: Mabthera
Two IV perfusions of 1000mg at 15 days intervals |
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| Study Arm (s) | Experimental: Rituximab
Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid .
Intervention: Drug: Mabthera |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | June 2014 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00525616 | ||||||||
| Other Study ID Numbers ICMJE | 2006/101/HP | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University Hospital, Rouen | ||||||||
| Study Sponsor ICMJE | University Hospital, Rouen | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Rouen | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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