Twice Weekly (for 6 Months) Patient Self-Administered Etanercept Injections for Vitiligo - Article Informed Consent; Ombudsman Programs; Patient's Rights
Clinical Trial: Twice Weekly (for 6 Months) Patient Self-Administered Etanercept Injections for Vitiligo
This study is currently recruiting patients.
Verified by University of Medicine and Dentistry New Jersey August 2005
|Vitiligo || Drug: Etanercept ||Phase II |
MedlinePlus related topics: Vitiligo
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Secondary Outcomes: Percentage of subjects achieving 75% or more repigmentation at 6 months (Excellent or better on PGA score); · Patient-Generated Global Assessment; · Skin Texture Assessment
Expected Total Enrollment: 40
Study start: November 2003; Expected completion: December 2007
- 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 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.
- 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.
- 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.
- Also, patients should not receive live vaccines 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 (EnbrelÒ)
- adalimumab (HumiraÔ)
- infliximab (RemicadeÒ) 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, efaluzimab, 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 (CHF of any severity, MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, uncontrolled hypertension (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg), or neurological disease; known 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.
Location and Contact Information
UMDNJ Clinical Research Center, New Brunswick, New Jersey, 08903, United States; Recruiting
Alice Gottlieb, MD, PhD, Principal Investigator, UMDNJ-RWJMS
Last Updated: August 23, 2005
Record first received: August 22, 2005
ClinicalTrials.gov Identifier: NCT00134368
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30
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