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Efficacy of Dapsone as a Steroid Sparing Agent in Pemphigus Vulgaris

Primary Purpose

Pemphigus Vulgaris

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dapsone

About this trial

This is an interventional treatment trial for Pemphigus Vulgaris

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00429533

First Posted

January 29, 2007

Last Updated

February 1, 2007

Sponsor

Jacobus Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00429533

Brief Title

Efficacy of Dapsone as a Steroid Sparing Agent in Pemphigus Vulgaris

Official Title

A Prospective Randomized Placebo-Controlled Clinical Trial of Dapsone as a Glucocorticoid-Sparing Agent in Maintenance Phase Pemphigus Vulgaris

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Terminated

Study Start Date

November 1996 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Jacobus Pharmaceutical

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pemphigus Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

48 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Dapsone

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: