- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00429533
Efficacy of Dapsone as a Steroid Sparing Agent in Pemphigus Vulgaris
February 1, 2007 updated by: Jacobus Pharmaceutical
A Prospective Randomized Placebo-Controlled Clinical Trial of Dapsone as a Glucocorticoid-Sparing Agent in Maintenance Phase Pemphigus Vulgaris
The purpose of this 12-month study was to determine the efficacy of dapsone as a glucocorticoid-sparing agent in maintenance phase pemphigus vulgaris.
Study Overview
Detailed Description
Patients were entered into the trial on steroids in combination with cytotoxic agents as needed.
The steroid dose was the lowest dose at which the patient's disease was controlled before the last flare (see eligibility criteria).
The patients were randomized to receive either Dapsone or placebo.
Treatment was to be started at a dose of 50 mg and increased by 25 mg increments each week once the hemoglobin was shown not to have dropped by more than 2 gm/dl.
The target dose was 150 mg and patients who did not respond could be advanced to 200 mg daily.
After beginning treatment, a standardized steroid taper was commenced.
A standardized steroid taper was suggested with tapering by 10 mg/wk for doses above 40 mg/day or more slowly if warranted.
A slower taper thereafter or an every other day dosing schedule would be elected according to the individual investigator's preference.
Flares were treated by increasing the dose of steroids - in the case of a mild flare to the last dose preceding the flare, in the case of a moderate flare by 20 mg/day and in the case of a severe flare by 40 mg/day.
Tapering was to be resumed once the disease had stabilized.
Disease activity was assessed by a simple scoring system for skin, mucosa, and sites involved.
Laboratory assessments initially weekly became monthly once the study medication dosage was stabilized.
Study Type
Interventional
Enrollment
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, United States, 60611-3010
- Northwestern University Medical Center
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper Hospital/University Medical Center
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New York
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New York, New York, United States, 10010
- The New York VA Medical Center, New York University
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Ohio
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Texas
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Dallas, Texas, United States, 75235
- University of Texas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologic evidence compatible with pemphigus vulgaris and direct immunofluorescence evidence of pemphigus vulgaris.
- Chronic disease that has been controlled with steroids and/or cytotoxics, e.g. maintenance phase.
- On prednisone 15 or more mg/day to around 40 mg/day or on prednisone 15 or more mg every other day (qod) to around 40 mg qod.
- Failure to taper steroids below a range of 15 mg/day to around 40 mg/day or 15 mg/qod to around 40 qod without flaring the disease.
- The steroid dosage at which the most recent flare occurred should not be less than 85% of the last (within 30 days) dosage which controlled the disease, i.e. 85% of the baseline steroid dosage. This is to ensure that patients will not have had a recent acute flare at the time of entry into the study, and be in the rapid steroid taper portion of their disease after such a flare.
- Two baseline steroid dosages as determined by prior flares. It is common that patients will be repetitively unable to taper below a certain baseline steroid dose without experiencing a mild flare of their disease. This baseline dose will be determined on two occasions during attempted tapers, and the baseline number then averaged to determine the dose of steroid the patient is on at the time of entry into the study.
- No pulse steroids, pulse cyclosphosphamide, or plasmapheresis within two months of beginning the protocol. This will exclude patients who had recent acute flares of their disease and may be on the rapid steroid taper portion of their disease. The patient must be in maintenance phase, as defined in the criteria listed in e.
- Patient understands the procedures and agrees to participate in the study program by giving written informed consent.
Exclusion Criteria:
- Patients able to taper steroids without recurrence of disease.
- Patients with early, severe disease that have not responded to high doses of prednisone, cytotoxics, plasmapheresis, or other modalities.
- Contraindications to the use of Dapsone, including severe anemia or G6PD deficiency.
- Patient has behavioral problems that might interfere with compliance.
- Pregnancy or breast-feeding.
- Younger than 18 or older than 80 years of age. Since PV is rare in patients younger than 18, it was decided to exclude this potentially different population. It is unlikely that this will exclude many patients. Dapsone induces a hemolytic anemia, which would be a particular problem for patients over age 80, who are more likely to have ischemic heart disease or other atherosclerotic vascular disease.
- History of allergy to dapsone.
- Ischemic heart disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The ability of patients to taper to ≤7.5mg/day within one year of reaching the maximum dosage of the study drug.
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Secondary Outcome Measures
Outcome Measure |
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Steroid dosage reduced by more than 25% within 4 months after completing the upward titration of the study drug.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Victoria P. Werth, MD, University of Pennsylvania
- Principal Investigator: Victoria P. Werth, MD, University of Pennsylvania
- Principal Investigator: Diana Chen, MD, Northwestern University
- Principal Investigator: Warren R Heymann, MD, Cooper Hospital/University Medical Center
- Principal Investigator: Neil Korman, MD, Case Western Reserve University School of Medicine
- Principal Investigator: Amit Pandya, MD, University of Texas
- Principal Investigator: M J Rico, MD, The New York VA Medical Center - New York University
- Principal Investigator: Michael D Tharp, MD, Rush University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 1996
Study Completion
February 1, 2004
Study Registration Dates
First Submitted
January 29, 2007
First Submitted That Met QC Criteria
January 30, 2007
First Posted (Estimate)
January 31, 2007
Study Record Updates
Last Update Posted (Estimate)
February 5, 2007
Last Update Submitted That Met QC Criteria
February 1, 2007
Last Verified
February 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Autoimmune Diseases
- Skin Diseases, Vesiculobullous
- Pemphigus
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Dapsone
Other Study ID Numbers
- 51,988
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pemphigus Vulgaris
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Cabaletta BioRecruitingMucosal -Dominant Pemphigus VulgarisUnited States
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Cairo UniversityCompletedOral Pemphigus VulgarisEgypt
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Hoffmann-La RocheAspreva PharmaceuticalsCompletedPemphigus Vulgaris (PV)Turkey, Switzerland, United States, Germany, United Kingdom, Ukraine, Israel, Canada
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argenxCompletedPemphigus Vulgaris | Pemphigus FoliaceusUnited States, Australia, Bulgaria, China, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Poland, Romania, Russian Federation, Serbia, Spain, Turkey, Ukraine, United Kingdom
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National Institute of Allergy and Infectious Diseases...Rho Federal Systems Division, Inc.; Autoimmunity Centers of ExcellenceTerminatedPemphigus Vulgaris | Pemphigus FoliaceusUnited States
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argenxCompletedPemphigus Vulgaris | Pemphigus FoliaceusGermany, Hungary, Israel, Italy, Ukraine
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argenxActive, not recruitingPemphigus Vulgaris | Pemphigus FoliaceusUnited States, Germany, Italy, Australia, Bulgaria, China, France, Georgia, Greece, Hungary, India, Israel, Japan, Poland, Romania, Russian Federation, Serbia, Spain, Turkey, Ukraine, United Kingdom
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Alexion PharmaceuticalsTerminatedPemphigus | Pemphigus Vulgaris | Pemphigus FoliaceusUnited States
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Principia Biopharma, a Sanofi CompanyPrincipia Biopharma Australia Pty Ltd.CompletedPemphigus VulgarisIsrael, Australia, Greece, Croatia, France
Clinical Trials on Dapsone
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Almirall, S.A.AllerganCompleted
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Almirall, S.A.AllerganCompleted
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Almirall, S.A.AllerganCompletedAcne VulgarisUnited States, Canada
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Vanderbilt University Medical CenterTerminated
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Almirall, S.A.AllerganCompleted