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

NCT00134368 | Completed Phase 2

• 1 other identifier: 4489
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitiligo

Keywords

vitiligo; etanercept

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• Percentage of subjects achieving 75% or more repigmentation at 6 months (Excellent or better on PGA score)

• Patient-Generated Global Assessment

• Skin texture assessment

Interventions

Etanercept DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

UMDNJ Psoriasis Center of Excellence

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Alice Gottlieb, MD, PhD

  UMDNJ-RWJMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 24, 2005
• Study Start: November 1, 2003
• Study Completion: December 1, 2007
• Last Updated: August 7, 2008

Record last verified: 2008-08

Locations

US (1)