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Tracking Information | |||||||||
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First Received Date † | May 8, 2007 | ||||||||
Last Updated Date | February 13, 2009 | ||||||||
Start Date † | August 2007 | ||||||||
Current Primary Outcome Measures † |
Assessment of total and new blister numbers over the 16 week period. Time to the cessation of new blister formation. The total dose of prednisone (mg/kg/d) during the 16 week treatment period. Parameters will be compared to the controls. [ Time Frame: 24 total weeks ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00472030 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Efficacy and Safety of Omalizumab in Bullous Pemphigoid | ||||||||
Official Title † | An Open Label Case Series on the Effects of Xolair (Omalizumab) in Bullous Pemphigoid | ||||||||
Brief Summary | The primary objective is to test the safety and efficacy of Xolair in the treatment of the autoimmune blistering disease, bullous pemphigoid (BP). This is a pilot, open label case-control study. Patients treated with Xolair will be compared to patients receiving standard treatment with prednisone. The enrollment period for the study is 24 weeks: 16 weeks active treatment and 8 additional weeks of observation. |
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Detailed Description | Objectives: The primary objective is to test the safety and efficacy of Xolair in the treatment of the autoimmune blistering disease, bullous pemphigoid (BP). Study Rationale: The current treatment for BP is non-specific immunosuppression, causing great morbidity in these patients. Recently, pathogenic IgE class autoantibodies have been identified in these patients. Development of a more targeted approach to treatment may reduce morbidity. Methodology: This is a pilot, open label case-control study. Patients treated with Xolair will be compared to patients receiving standard treatment with prednisone. Number of centers & patients: This is a single center study that will enroll 12 patients. Population: Bullous pemphigoid patients, meeting clinical, histological and immunologic criteria for the disease will be enrolled. Pregnant women, children < 18, and patients unable to give consent will be excluded from this preliminary study. Investigational drug: Xolair® (Omalizumab) Study duration: 24 weeks: 16 weeks active treatment, 8 additional weeks of observation Evaluation criteria: Primary: 1. Time to cessation of new blister formation. 2. Percent body surface involved before and after treatment 3. Total and average daily dose of prednisone required in 30, 60 and 180 days after starting Xolair. Secondary: 1. circulating eosinophils 2. Measurement of circulating anti-BMZ (basement membrane zone) autoantibodies 3. Histamine release assay. |
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Study Phase | Phase IV | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
Condition † | Bullous Pemphigoid | ||||||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 12 | ||||||||
Estimated Completion Date | June 2010 | ||||||||
Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00472030 | ||||||||
Responsible Party | Janet A. Fairley, M.D., University of Iowa | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | University of Iowa | ||||||||
Collaborators †† | Genentech | ||||||||
Investigators † |
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Information Provided By | University of Iowa | ||||||||
Verification Date | February 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |