Efficacy of Dapsone as a Steroid Sparing Agent in Pemphigus Vulgaris

NCT00429533 | Terminated Phase 2

• 1 other identifier: 51,988
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this 12-month study was to determine the efficacy of dapsone as a glucocorticoid-sparing agent in maintenance phase pemphigus vulgaris.

Conditions

Pemphigus Vulgaris

Outcome Measures

Primary Outcomes (1)

• The ability of patients to taper to ≤7.5mg/day within one year of reaching the maximum dosage of the study drug.

Secondary Outcomes (1)

• Steroid dosage reduced by more than 25% within 4 months after completing the upward titration of the study drug.

Interventions

Dapsone DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jacobus Pharmaceutical: lead

Study Sites (8)

Northwestern University Medical Center

Chicago, Illinois, 60611-3010, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Cooper Hospital/University Medical Center

Camden, New Jersey, 08103, United States

Location

The New York VA Medical Center, New York University

New York, New York, 10010, United States

Location

Case Western Reserve University School of Medicine

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Werth VP, Fivenson D, Pandya AG, Chen D, Rico MJ, Albrecht J, Jacobus D. Multicenter randomized, double-blind, placebo-controlled, clinical trial of dapsone as a glucocorticoid-sparing agent in maintenance-phase pemphigus vulgaris. Arch Dermatol. 2008 Jan;144(1):25-32. doi: 10.1001/archderm.144.1.25.

  PMID: 18209165 DERIVED

MeSH Terms

Conditions

Pemphigus

Interventions

Dapsone

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals

Study Officials

• Victoria P. Werth, MD

  University of Pennsylvania

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 31, 2007
• Study Start: November 1, 1996
• Study Completion: February 1, 2004
• Last Updated: February 5, 2007

Record last verified: 2007-02

Locations

US (8)