Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-25 @ 3:00 PM
Study NCT ID:
NCT00134368
Status:
COMPLETED
Last Update Posted:
2008-08-07
First Post:
2005-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Efficacy and Safety of Etanercept in Adults With Vitiligo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2007-12'}, 'lastUpdateSubmitDate': '2008-08-06', 'studyFirstSubmitDate': '2005-08-22', 'studyFirstSubmitQcDate': '2005-08-23', 'lastUpdatePostDateStruct': {'date': '2008-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percent of subjects achieving 50% or more repigmentation at 6 months (Good or better on Physician's Global Assessment [PGA] score)"}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects achieving 75% or more repigmentation at 6 months (Excellent or better on PGA score)'}, {'measure': 'Patient-Generated Global Assessment'}, {'measure': 'Skin texture assessment'}]}, 'conditionsModule': {'keywords': ['vitiligo', 'etanercept'], 'conditions': ['Vitiligo']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy and safety of etanercept in adults with vitiligo.', 'detailedDescription': 'Subjects will self-administer etanercept 50 mg SQ twice weekly for 6 months. Lesion repigmentation will be evaluated at monthly visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Vitiligo patients aged 18 years and older\n* Vitiligo patients with evaluable lesions; duration of 3 months to 10 years.\n* Disease interferes significantly with quality of life and/or involving 3% or more body surface area\n* Subjects must have a negative tuberculin (TB) skin test at entry into the study\n* 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.\n* 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.\n* Subject or designee must have the ability to self-inject investigational product or have a care giver at home who can administer subcutaneous injections\n* 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.\n\nExclusion Criteria:\n\n* Unable to consent\n* History of non-compliance with other therapies\n* Concurrent therapy for vitiligo\n* Systemic or photo-therapy within 4 weeks\n* Topical therapy within 2 weeks\n* Any medical condition in which etanercept would be contraindicated\n* Any internal malignancy within 5 years (fully excised cutaneous, basal cell carcinoma or squamous cell carcinoma are exceptions)\n* Pregnancy, not practicing effective birth control, or inability to practice safe sex during the length of the study.\n* Lactation\n* History of alcohol or drug abuse one year before and during the study.\n* Any participation in another investigational drug study during the 4 weeks preceding this study.\n* Known HIV-positive status; known history of any other mycobacterial disease or any other immuno-suppressing disease.\n* 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.\n* Patients should not receive live vaccines for 3 months prior to, or while on, study.\n* A prior history of tuberculosis, and/or a positive PPD skin test and positive CXR at screening.\n* Patients with previous or current exposure to any of the following TNF antagonists:\n\n * etanercept (Enbrel);\n * adalimumab (Humira); or\n * infliximab (Remicade).\n\nThese 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.\n\n* 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.\n* Chronic hepatitis B or hepatitis C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy."}, 'identificationModule': {'nctId': 'NCT00134368', 'briefTitle': 'Study of the Efficacy and Safety of Etanercept in Adults With Vitiligo', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Pilot, Investigator-Initiated, Proof-of-Concept, Study of the Efficacy and Safety of Etanercept (Enbrel) in Adults With Vitiligo', 'orgStudyIdInfo': {'id': '4489'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Etanercept', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ Psoriasis Center of Excellence', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Alice Gottlieb, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMDNJ-RWJMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}}}}