Study of the Efficacy and Safety of Etanercept in Adults With Vitiligo
This study has been completed.
Information provided by:
Rutgers, The State University of New Jersey
First received: August 22, 2005
Last updated: August 6, 2008
Last verified: August 2008
The purpose of this study is to investigate the efficacy and safety of etanercept in adults with vitiligo.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Pilot, Investigator-Initiated, Proof-of-Concept, Study of the Efficacy and Safety of Etanercept (Enbrel) in Adults With Vitiligo
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:
| Study Start Date:
| Estimated Study Completion Date:
Subjects will self-administer etanercept 50 mg SQ twice weekly for 6 months. Lesion repigmentation will be evaluated at monthly visits.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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.
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
|UMDNJ Psoriasis Center of Excellence
|New Brunswick, New Jersey, United States, 08903 |
University of Medicine and Dentistry of New Jersey
||Alice Gottlieb, MD, PhD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 22, 2005
||August 6, 2008
||United States: Food and Drug Administration
Keywords provided by Rutgers, The State University of New Jersey:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents