Pemphigus Vulgaris Clinical Trial
Official title:
A Double-Blinded, Placebo-Controlled Study of Etanercept (Enbrel) in the Treatment of Pemphigus Vulgaris
Verified date | May 2008 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of the study is to find out about the effectiveness and the safety of an
investigational drug called etanercept (Enbrel) to treat pemphigus vulgaris. Pemphigus
vulgaris is a potentially life threatening blistering condition that currently has no cure.
An investigational drug is one that has not been approved by the United States (US) Food and
Drug Administration (FDA) to treat a particular condition or disease. Etanercept has been
approved by the FDA to treat rheumatoid arthritis, juvenile rheumatoid arthritis, and
psoriasis, but not pemphigus vulgaris.
Status | Completed |
Enrollment | 12 |
Est. completion date | November 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Summary Inclusion Criteria: - Understand and sign the written informed consent form and be willing and able to comply with the procedures of the study - Have a clinical diagnosis of pemphigus vulgaris - Have at least 6 active pemphigus lesions (blisters or erosions) - Have no adverse effects due to combining etanercept with concurrent pemphigus medications - Be on stable dose of current pemphigus medications for at least one month - Females of child-bearing potential must have a negative urine pregnancy test prior to treatment and agree to practice an acceptable method of birth control (oral contraceptives, hormonal implant devices, Depo-Provera, condom with spermicide, diaphragm with contraceptive cream or foam, or intrauterine device) during the course of the study - Be at least 18 years old at time of enrollment - Be able to adhere to the study visit schedule and other protocol requirements |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Clinical Unit for Research Trials in Skin | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Brigham and Women's Hospital, Stanford University |
United States,
Alecu M, Alecu S, Coman G, Galatescu E, Ursaciuc C. ICAM-1, ELAM-1, TNF-alpha and IL-6 in serum and blister liquid of pemphigus vulgaris patients. Roum Arch Microbiol Immunol. 1999 Apr-Jul;58(2):121-30. — View Citation
Alpsoy E, Yilmaz E, Basaran E, Yazar S, Cetin L. Is the combination of tetracycline and nicotinamide therapy alone effective in pemphigus? Arch Dermatol. 1995 Nov;131(11):1339-40. — View Citation
Berookhim B, Fischer HD, Weinberg JM. Treatment of recalcitrant pemphigus vulgaris with the tumor necrosis factor alpha antagonist etanercept. Cutis. 2004 Oct;74(4):245-7. — View Citation
D'Auria L, Bonifati C, Mussi A, D'Agosto G, De Simone C, Giacalone B, Ferraro C, Ameglio F. Cytokines in the sera of patients with pemphigus vulgaris: interleukin-6 and tumour necrosis factor-alpha levels are significantly increased as compared to healthy subjects and correlate with disease activity. Eur Cytokine Netw. 1997 Dec;8(4):383-7. — View Citation
Goldstein BG and Goldstein AO. Pemphigus and bullous pemphigoid. UpToDate.
Sacher C, Rubbert A, König C, Scharffetter-Kochanek K, Krieg T, Hunzelmann N. Treatment of recalcitrant cicatricial pemphigoid with the tumor necrosis factor alpha antagonist etanercept. J Am Acad Dermatol. 2002 Jan;46(1):113-5. — View Citation
Stanley JR. Pemphigus. In Fizpatrick's Dermatology in General Medicine, 6th edition. Eds. Freedberg IM, Eisen AZ, Wolff K, Austen KF, et al. New York: McGraw-Hill, 2003. 558-567.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the mean time (in days) it takes to reduce active lesions, including blisters and erosions, by 50% | |||
Primary | Determine whether etanercept is a possible steroid-sparing treatment option. This will be determined by tapering the patient's existing steroid dose once our primary endpoint has been reached. |
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