Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-29 @ 7:27 AM
Study NCT ID:
NCT02155192
Status:
COMPLETED
Last Update Posted:
2014-11-03
First Post:
2014-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploratory Genetic Study in Participants With Psoriasis
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Two buccal swab samples will be collected to extract Deoxyribonucleic acid (DNA).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 712}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-31', 'studyFirstSubmitDate': '2014-06-02', 'studyFirstSubmitQcDate': '2014-06-02', 'lastUpdatePostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Responders With Association Between Clinical Response and Genetic Factor', 'timeFrame': 'Day 1', 'description': "Participants with clinical response from previous studies will be evaluated for the association with genetic factors (for example, human leukocyte antigen \\[HLA\\], Cw6 allele). Clinical response in previous studies were evaluated by psoriasis area and severity index (PASI) score: a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a participant's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score, scale ranges from 0 (best) to 72 (worst); and physician global assessment (PGA): The PGA is 6-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe). Percentage of participants will be reported."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CNTO1959PSO2001', 'C0743T08', 'C0743T09', 'C0743T12', 'Psoriasis', 'Pharmacogenomics'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the association between genetic factors and response to treatment (guselkumab, ustekinumab, adalimumab, or etanercept) and psoriasis (scaly skin rash).', 'detailedDescription': 'This is a Phase 0, exploratory (intended to be conducted early in Phase 1, involve limited human exposure, have no therapeutic intent and are not intended to examine clinical tolerability), multicenter (when more than one hospital or medical school team work on a medical research study) and pharmacogenomics study in participants with psoriasis. Participants who were treated in study Phase 2 NCT01483599 (X-PLORE), Phase 3 NCT00267969 (PHOENIX 1), Phase 3 NCT00307437 (PHOENIX 2) or Phase 3 NCT00454584 (ACCEPT), will be returning to their study site where a deoxyribonucleic acid (DNA) sample will be obtained for pharmacogenomics assessment. There will be no follow-up beyond the study site visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who were treated in the CNTO1959PSO2001 study, C0743T08 study, C0743T09 or C0743T12 study will be assessed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have been randomly assigned and treated in the NCT01483599 (X-PLORE), NCT00267969 (PHOENIX 1), NCT00307437 (PHOENIX-2) , or NCT00454584 (ACCEPT) studies\n* Sign an informed consent document indicating that they understand the purpose of and procedures required for this study and are willing to participate in this study\n\nExclusion Criteria:\n\n* Participants has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments'}, 'identificationModule': {'nctId': 'NCT02155192', 'briefTitle': 'An Exploratory Genetic Study in Participants With Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'Exploratory Genetic Study in Subjects With Moderate to Severe Psoriasis', 'orgStudyIdInfo': {'id': 'CR103877'}, 'secondaryIdInfos': [{'id': 'NOCOMPOUNDPSO0001', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Participants who participated in NCT01483599 (X-PLORE) study.', 'interventionNames': ['Drug: No Intervention']}, {'label': 'Cohort 2', 'description': 'Participants who participated in NCT00267969 (PHOENIX 1) study.', 'interventionNames': ['Drug: No Intervention']}, {'label': 'Cohort 3', 'description': 'Participants who participated in NCT00307437 (PHOENIX-2) study.', 'interventionNames': ['Drug: No Intervention']}, {'label': 'Cohort 4', 'description': 'Participants who participated in NCT00454584 (ACCEPT) study.', 'interventionNames': ['Drug: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'DRUG', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}