Study of the Efficacy and Safety of Etanercept in Adults With Vitiligo

August 6, 2008 updated by: University of Medicine and Dentistry of New Jersey

Pilot, Investigator-Initiated, Proof-of-Concept, Study of the Efficacy and Safety of Etanercept (Enbrel) in Adults With Vitiligo

The purpose of this study is to investigate the efficacy and safety of etanercept in adults with vitiligo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will self-administer etanercept 50 mg SQ twice weekly for 6 months. Lesion repigmentation will be evaluated at monthly visits.

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • UMDNJ Psoriasis Center of Excellence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Vitiligo patients aged 18 years and older
  • Vitiligo patients with evaluable lesions; duration of 3 months to 10 years.
  • Disease interferes significantly with quality of life and/or involving 3% or more body surface area
  • Subjects must have a negative tuberculin (TB) skin test at entry into the study
  • If subject is a female of childbearing potential, she must agree to use adequate contraception (adequate contraception can include abstinence) and must have a negative serum pregnancy test the day of administration of study medication.
  • If subject is a male and has reached puberty, he must agree to use adequate contraception during the study and for 1 month after discontinuation from study.
  • Subject or designee must have the ability to self-inject investigational product or have a care giver at home who can administer subcutaneous injections
  • Subject must be able to give informed consent; must authorize release and use of protected health information; and, if applicable, must assent to participate prior to enrollment to this study.

Exclusion Criteria:

  • Unable to consent
  • History of non-compliance with other therapies
  • Concurrent therapy for vitiligo
  • Systemic or photo-therapy within 4 weeks
  • Topical therapy within 2 weeks
  • Any medical condition in which etanercept would be contraindicated
  • Any internal malignancy within 5 years (fully excised cutaneous, basal cell carcinoma or squamous cell carcinoma are exceptions)
  • Pregnancy, not practicing effective birth control, or inability to practice safe sex during the length of the study.
  • Lactation
  • History of alcohol or drug abuse one year before and during the study.
  • Any participation in another investigational drug study during the 4 weeks preceding this study.
  • Known HIV-positive status; known history of any other mycobacterial disease or any other immuno-suppressing disease.
  • Presence of a grade 3 or 4 infection < 30 days prior to the screening visit; between the screening visit and the first day of treatment on study; or any time during the study that, in the opinion of the Investigator, would preclude participation in the study.
  • Patients should not receive live vaccines for 3 months prior to, or while on, study.
  • A prior history of tuberculosis, and/or a positive PPD skin test and positive CXR at screening.

  • Patients with previous or current exposure to any of the following TNF antagonists:

    • etanercept (Enbrel);
    • adalimumab (Humira); or
    • infliximab (Remicade).

These patients will not be eligible, even with a wash-out. Patients with previous or current exposure to Kineret will NOT be eligible, even with a wash-out. However, patients with prior or current exposure to biologics directed against T-cells (e.g. alefacept, efalizumab, siplizumab, etc.) will be eligible for enrollment into the study after a wash-out period of 4 weeks before first dose of study drug (baseline visit). It has to be protocol specific also.

  • The subject has, in the Investigator's opinion, a chronic, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular (congestive heart failure [CHF] of any severity; myocardial infarction [MI], cerebrovascular accident [CVA] or transient ischemic attack [TIA] within 3 months of screening visit; unstable angina pectoris; uncontrolled hypertension [sitting systolic blood pressure (BP) < 80 mm Hg or > 160 or diastolic BP > 100 mm Hg]), or neurological disease; known systemic lupus erythematosus (SLE); diabetes; or any other concomitant medical condition that places the participant at risk by participating this study and/or that may interfere with the conduct of the study.
  • Chronic hepatitis B or hepatitis C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent of subjects achieving 50% or more repigmentation at 6 months (Good or better on Physician's Global Assessment [PGA] score)

Secondary Outcome Measures

Outcome Measure
Percentage of subjects achieving 75% or more repigmentation at 6 months (Excellent or better on PGA score)
Patient-Generated Global Assessment
Skin texture assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Investigators

  • Principal Investigator: Alice Gottlieb, MD, PhD, Umdnj-Rwjms

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (Estimate)

August 24, 2005

Study Record Updates

Last Update Posted (Estimate)

August 7, 2008

Last Update Submitted That Met QC Criteria

August 6, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4489

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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