Status:
COMPLETED
Study of the Efficacy and Safety of Etanercept in Adults With Vitiligo
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Conditions:
Vitiligo
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the efficacy and safety of etanercept in adults with vitiligo.
Detailed Description
Subjects will self-administer etanercept 50 mg SQ twice weekly for 6 months. Lesion repigmentation will be evaluated at monthly visits.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00134368
Start Date
November 1 2003
End Date
December 1 2007
Last Update
August 7 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UMDNJ Psoriasis Center of Excellence
New Brunswick, New Jersey, United States, 08903