Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT01132235
Status:
UNKNOWN
Last Update Posted:
2010-05-28
First Post:
2010-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-27', 'studyFirstSubmitDate': '2010-05-25', 'studyFirstSubmitQcDate': '2010-05-26', 'lastUpdatePostDateStruct': {'date': '2010-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The proportion of patients achieving a Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12.", 'timeFrame': '12 weeks', 'description': "Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12 will measure efficacy of retreatment with etanercept"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of re-treatment with etanercept 50mg subcutaneous injections twice weekly for 12 weeks in subjects who have previously been treated etanercept and efficacy diminished.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects with psoriasis who have previously been treated with etanercept for a minimum of 6 months and discontinued treatment due to loss of efficacy. Every attempt will be made to obtain loss of efficacy history from the subject's medical chart;when etanercept was commenced and terminated and description of patient's psoriasis on termination and details of new treatment commenced. Subjects must have failed their latest psoriasis treatment after a period of three months. This will be measured as a PGA of ≥ 3.\n* There is no specific requirement as to when prior treatment with etanercept occurred and no requirement as to what type of treatment(s) used between initial and subsequent treatments.\n* Are ≥ 18 years of age\n* PGA ≥ 3\n* BSA minimum of 5%\n\nTuberculosis inclusion criteria\n\n* Have no history of latent or active TB prior to screening.\n* Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.\n* Have had no recent close contact with a person with active TB.\n* Within 1 month prior to the first administration of study have a negative tuberculin skin test.\n\n * The ability to give written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Current enrollment in any other investigational device or investigational drug trial(s), or receipt of any other investigational agent(s) within 28 days before baseline visit.\n* Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept.\n* Latex sensitivity \\[NB: only applicable if they are using prefilled syringe or prefilled SureClick™ autoinjector presentations\\]\n* Prior or concurrent use of cyclophosphamide therapy\n* Concurrent sulfasalazine therapy.\n* A positive HBV test or known history of any other immuno-suppressing disease.\n* Any mycobacterial disease or high risk factors for tuberculosis (TB), such as family member with TB, positive purified protein derivative (PPD) or taking anti-tuberculosis medication.\n* Active or chronic infection within 4 weeks before screening visit, or between the screening and baseline visits.\n* History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection and Hepatitis C, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB, or other opportunistic infections\n* If etanercept was previously discontinued due to a serious adverse event\n* Severe comorbidities (diabetes mellitus requiring insulin; CHF of any severity; or myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months of screening visit; unstable angina pectoris; uncontrolled hypertension (sitting systolic BP \\<80 mm Hg or \\> 160 or diastolic BP \\> 100 mm Hg); oxygen-dependent severe pulmonary disease; history of cancer within 5 years \\[other than resected cutaneous basal or squamous cell carcinoma of the skin or in situ cervical cancer\\])\n* Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis, optic neuritis or seizure disorder.\n* Use of a live vaccine 90 days prior to screening visit, or concurrent use of a live vaccine.\n* Any condition or circumstances judged by the patient's physician \\[or the investigator or medically qualified study staff\\] to render this clinical trial detrimental or otherwise unsuitable for the patient's participation.\n* Female subjects who are pregnant, nursing or planning pregnancy (both men and women) and not using acceptable methods of birth control during the trial (hormonal, barriers, abstinence).\n* Women who are breast feeding\n\nHistory of non-compliance with other therapies.\n\n* History of alcohol abuse within the last 12 months\n* Concurrent use of anakinra\n* Subjects who cannot discontinue any of the drugs below for 2 weeks prior to the baseline visit or during the study;\n\nA two week wash out period is appropriate as it would be unethical to expect subjects whose disease if flaring to remain untreated for a longer period of time. The first dose of etanercept will be administered two weeks after the last biologic dose.\n\n* Immunosuppressants, antimalarials, or sulfasalazine.\n* Other Ani-TNFs\n* Cyclosporine\n* Efalizumab\n* Azathioprine\n* Hydroxyurea\n* Live vaccines\n* Tacrolimus\n* Oral retinoids (isotretinoin,acitretin,bexarotene)\n* Ultra violet light therapies"}, 'identificationModule': {'nctId': 'NCT01132235', 'acronym': 'ENBRECAP2009', 'briefTitle': 'An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use', 'organization': {'class': 'OTHER', 'fullName': 'Florida Academic Dermatology Centers'}, 'officialTitle': 'An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use', 'orgStudyIdInfo': {'id': 'ENBRECAP2009'}}, 'armsInterventionsModule': {'interventions': [{'name': 'etanercept', 'type': 'BIOLOGICAL', 'description': '50mgs subcutaneous injections twice a week for 12 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Annika M Grant, RN.MBA', 'role': 'CONTACT', 'email': 'annikagrant@bellsouth.net', 'phone': '305-324-2110', 'phoneExt': '210'}], 'facility': 'Florida Academic Dermatology Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida Academic Dermatology Centers', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Francisco A Kerdel, M.D.', 'oldOrganization': 'Florida Academic Dermatology Centers'}}}}