Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00429533
Other study ID # 51,988
Secondary ID
Status Terminated
Phase Phase 2
First received January 29, 2007
Last updated February 1, 2007
Start date November 1996
Est. completion date February 2004

Study information

Verified date February 2007
Source Jacobus Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 48
Est. completion date February 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dapsone


Locations

Country Name City State
United States Cooper Hospital/University Medical Center Camden New Jersey
United States Northwestern University Medical Center Chicago Illinois
United States Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois
United States Case Western Reserve University School of Medicine Cleveland Ohio
United States University of Texas Dallas Texas
United States Henry Ford Hospital Detroit Michigan
United States The New York VA Medical Center, New York University New York New York
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Jacobus Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The ability of patients to taper to =7.5mg/day within one year of reaching the maximum dosage of the study drug.
Secondary Steroid dosage reduced by more than 25% within 4 months after completing the upward titration of the study drug.
See also
  Status Clinical Trial Phase
Recruiting NCT04422912 - A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV) Phase 1
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT04117529 - Phenotypic and Functional Characterisation of Human B-cell Response in Pemphigus N/A
Completed NCT03334058 - A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With Pemphigus Phase 2
Terminated NCT03239470 - Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus Phase 1
Completed NCT00606749 - Use of KC706 for the Treatment of Pemphigus Vulgaris Phase 2
Recruiting NCT05594472 - Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid Phase 3
Completed NCT02383589 - A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV) Phase 3
Withdrawn NCT03780166 - A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris Phase 2
Recruiting NCT04096222 - Comparative Analysis of the Th17 Cellular Response in Active and Inactive Pemphigus Vulgaris Patients
Not yet recruiting NCT03177213 - Serum IL-21 Levels in Patients With Pemphigus Vulgaris N/A
Completed NCT00135720 - Study of Etanercept (Enbrel) in the Treatment of Pemphigus Vulgaris Phase 2
Completed NCT00063752 - Safety Study of PI-0824 to Treat Pemphigus Vulgaris Phase 1
Terminated NCT03075904 - A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus) Phase 1/Phase 2
Terminated NCT04598477 - A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus) Phase 3
Completed NCT02704429 - A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris Phase 2
Completed NCT00626678 - Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone Phase 2
Active, not recruiting NCT05338112 - Role of Tzanck Smear in Determining Pemphigus Vulgaris Disease Activity
Completed NCT06167408 - Identifying Factors Influencing In-Hospital Relapse in Pemphigus Patients
Recruiting NCT05303272 - A Study to Evaluate Efficacy and Safety of Abatacept in Participants of Pemphigus Vulgaris (PV) Phase 4