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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00134368
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : August 7, 2008
Information provided by:
Rutgers, The State University of New Jersey

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

Condition or disease Intervention/treatment Phase
Vitiligo Drug: Etanercept Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot, Investigator-Initiated, Proof-of-Concept, Study of the Efficacy and Safety of Etanercept (Enbrel) in Adults With Vitiligo
Study Start Date : November 2003
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo
Drug Information available for: Etanercept

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

Secondary Outcome Measures :
  1. Percentage of subjects achieving 75% or more repigmentation at 6 months (Excellent or better on PGA score)
  2. Patient-Generated Global Assessment
  3. Skin texture assessment

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00134368

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United States, New Jersey
UMDNJ Psoriasis Center of Excellence
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
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Principal Investigator: Alice Gottlieb, MD, PhD UMDNJ-RWJMS
Layout table for additonal information Identifier: NCT00134368    
Other Study ID Numbers: 4489
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: August 7, 2008
Last Verified: August 2008
Keywords provided by Rutgers, The State University of New Jersey:
Additional relevant MeSH terms:
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Pigmentation Disorders
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors