Trial record 1 of 10 for:    "Pemphigus vulgaris"
Previous Study | Return to List | Next Study

Study of Etanercept (Enbrel) in the Treatment of Pemphigus Vulgaris

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Stanford University
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00135720
First received: August 24, 2005
Last updated: May 19, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Pemphigus Vulgaris
Drug: Enbrel (Etanercept)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blinded, Placebo-Controlled Study of Etanercept (Enbrel) in the Treatment of Pemphigus Vulgaris

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Determine the mean time (in days) it takes to reduce active lesions, including blisters and erosions, by 50%
  • 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.

Estimated Enrollment: 12
Study Start Date: June 2004
Study Completion Date: November 2007
Detailed Description:

People with pemphigus vulgaris have been found to have an increased amount of a substance called tumor-necrosis factor-alpha (TNF-alpha) in their blood. Etanercept may control pemphigus vulgaris by blocking the effect of TNF-alpha. Patients diagnosed with pemphigus vulgaris have been asked to participate in this research study.

Enrolled subjects will be given either etanercept or placebo. A placebo looks just like the study drug but contains no active medication. Placebos help study doctors find out if the effects of the study drug are due to the drug itself or just because of being in the study. This type of study design helps measure the true effectiveness of a treatment. Patients have 2 chances in 3 of receiving etanercept and 1 chance in 3 of receiving placebo.

The researchers expect to enroll 24 subjects in this study. Up to 16 subjects will be enrolled at Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH).

This study is sponsored by Amgen, Inc., the manufacturer of etanercept.

If taking part in another research study or have taken part in a research study in the last 28 days, patients will not be able to take part in this study. Patients cannot be on multiple studies simultaneously; however, exceptions are made for non-invasive, non-interventional, and observational studies.

This study will last about 16 weeks with a total of 6 study visits: screening, week 0 (baseline), weeks 2, 4, 8 and 16. The participants will be able to continue on your current medications for pemphigus throughout the study.

All participants must be at least 18 years of age with a clinical diagnosis of pemphigus vulgaris and at least 6 active blisters or erosions. Neither pregnant nor nursing women will be included in the study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135720

Locations
United States, Massachusetts
Clinical Unit for Research Trials in Skin
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Brigham and Women's Hospital
Stanford University
Investigators
Principal Investigator: Alexandra B Kimball, MD, MPH CURTIS - Clinical Unit for Research Trials in Skin at Partners (MGH and BWH)
  More Information

Additional Information:
Publications:
Responsible Party: Alexandra B. Kimball, Massachusetts General Hospital, Boston, MA 02114
ClinicalTrials.gov Identifier: NCT00135720     History of Changes
Other Study ID Numbers: 2004-P-002142, 79639;
Study First Received: August 24, 2005
Last Updated: May 19, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Pemphigus Vulgaris
Chronic Pemphigus
Etanercept
Enbrel
anti-TNF-alpha
TNF-alpha antagonist
biologic
immunomodulator
subcutaneous medication

Additional relevant MeSH terms:
Pemphigus
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Skin Diseases, Vesiculobullous
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014