Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus
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|ClinicalTrials.gov Identifier: NCT00656656|
Recruitment Status : Completed
First Posted : April 11, 2008
Results First Posted : December 22, 2016
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pemphigus||Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine
Protein A Immunoadsorption: performed on 3 consecutive days every 3 weeks
Rituximab: 1000 mg i.v. given twice at a 2-week interval
Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days every 3 weeks
Azathioprine: 2.5 mg/kg body weight daily p.o.
- Number of Patients Achieving a Short- and Long-term Remission of Pemphigus [ Time Frame: up to 43 months ]Clinical remission was graded as partial remission on therapy, complete remission on therapy and complete remission off therapy, as described by Murell et al, J Am Acad Dermatol, 2008; 58:1043-6.
- Number of Patients Who Experienced Side-effects of Treatment [ Time Frame: up to 43 months ]Patients who experienced side-effects were counted. In addition, the nature and severity of side-effects were recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656656
|Department of Dermatology, University of Luebeck|
|Luebeck, Schleswig-Holstein, Germany, 23552|
|Principal Investigator:||Detlef Zillikens, MD||Department of Dermatology, University of Luebeck|