Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00656656|
Recruitment Status : Completed
First Posted : April 11, 2008
Results First Posted : December 22, 2016
Last Update Posted : March 13, 2017
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Diagnosis of pemphigus confirmed by immunofluorescence and desmoglein ELISA.
- Severe disease or past treatment(s) not effective or past treatment(s) not tolerated.
- General condition too poor to tolerate immunoadsorption treatment.
- Severe dementia or psychiatric disease.
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|
|Responsible Party:||Michael Kasperkiewicz, Dermatologist, University of Luebeck|
|Other Study ID Numbers:||
|First Posted:||April 11, 2008 Key Record Dates|
|Results First Posted:||December 22, 2016|
|Last Update Posted:||March 13, 2017|
|Last Verified:||January 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Skin Diseases, Vesiculobullous
Immune System Diseases
Antineoplastic Agents, Immunological
Physiological Effects of Drugs
Peripheral Nervous System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action