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

This study has been completed.
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00134368
First received: August 22, 2005
Last updated: August 6, 2008
Last verified: August 2008
  Purpose

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


Condition Intervention Phase
Vitiligo
Drug: Etanercept
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

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

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

Estimated Enrollment: 40
Study Start Date: November 2003
Estimated Study Completion Date: December 2007
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00134368

Locations
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
Investigators
Principal Investigator: Alice Gottlieb, MD, PhD UMDNJ-RWJMS
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00134368     History of Changes
Other Study ID Numbers: 4489
Study First Received: August 22, 2005
Last Updated: August 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
vitiligo
etanercept

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
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 30, 2014