Viewing Study NCT03982394


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Study NCT ID: NCT03982394
Status: COMPLETED
Last Update Posted: 2025-11-17
First Post: 2019-06-10
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2759}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2019-06-10', 'studyFirstSubmitQcDate': '2019-06-10', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 90', 'timeFrame': 'From Month 4 to 3 years', 'description': 'PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.'}, {'measure': 'Time to first treatment change', 'timeFrame': 'From Week 0 (Baseline) to first treatment change', 'description': 'Identify time to first treatment change including discontinuation, dose escalation and dosing interval shortening'}], 'secondaryOutcomes': [{'measure': 'Time to first treatment change rate', 'timeFrame': 'At 1 year, 2 year, and 3 year', 'description': 'Time to first treatment change including discontinuation, dose escalation and dose interval shortening.'}, {'measure': 'Percentage of participants who achieved Static Physicians Global Assessment (sPGA) 0/1 or sPGA 0', 'timeFrame': 'Monthly for up to 3 years', 'description': 'The sPGA is the physician\'s current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. sPGA scores demonstrate overall psoriatic disease with a lower score indicating less body coverage. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the patient\'s previous disease states, whether at Baseline or at a previous visit.'}, {'measure': 'Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 75, 90, or 100', 'timeFrame': 'Monthly for up to 3 years', 'description': 'PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. Each threshold will be analyzed separately.'}, {'measure': 'Percentage of participants who achieved Absolute PASI<=5, <=3 or <=1', 'timeFrame': 'Monthly for up to 3 years', 'description': 'Used to assess the benefit of psoriasis therapy. Each threshold will be analyzed separately.'}, {'measure': 'Time to achieve sPGA 0/1 or sPGA 0', 'timeFrame': 'Up to 3 years', 'description': 'The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores.'}, {'measure': 'Time to achieve PASI 75, 90,or 100', 'timeFrame': 'Up to 3 years', 'description': 'PASI 75, 90, or 100 defined as at least a 75%/ 90%/ 100% reduction in PASI relative to Week 0 (Baseline). Each threshold will be analyzed separately.'}, {'measure': 'Percentage of participants who achieve sPGA 0/1 or sPGA 0 at 4 Months and maintained the response status at 1 Year, 2 Years and 3 Years without increasing the dose or shortening the dose interval', 'timeFrame': 'At 4 months to 1 year, 2 years, and 3 years', 'description': 'Percentage of participants who achieve sPGA 0/1 or sPGA 0 at 4 Months and maintained the response status at 1 Year, 2 Years and 3 Years without increasing the dose or shortening the dose interval.'}, {'measure': 'Percentage of participants who achieved PASI 90 or PASI 100 at 4 Months and maintained the response status at 1 Year, 2 Years, and 3 Years without changing the indicated dose or dosing interval', 'timeFrame': 'At 4 months and 1 year, 2 years, and 3 years', 'description': 'Percentage of participants who achieved PASI 90 or PASI 100 demonstrating a 90 or 100% reduction in PASI at 4 Months and maintained the response status at 1 Year, 2 Years, and 3 Years without changing the indicated dose or dosing interval.'}, {'measure': 'Change in PASI', 'timeFrame': 'From Week 0 to up to 3 years', 'description': 'PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.'}, {'measure': 'Change in Body Surface Area (BSA)', 'timeFrame': 'From Week 0 to up to 3 years', 'description': 'BSA can be used to quantify the severity of psoriasis. A decrease in BSA affected by psoriasis indicates improvement.'}, {'measure': 'Change in Dermatology Quality of Life Index (DLQI) Score', 'timeFrame': 'From Week 0 to up to 3 years', 'description': "The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool. The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. Scores range from 0 (not relevant/not at all) to 3 (very much)."}, {'measure': 'Percentage of participants who achieve DLQI 0/1', 'timeFrame': 'Monthly for up to 3 years', 'description': "The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool. The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. The higher the DLQI score, the more quality of life is impaired."}, {'measure': 'Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score', 'timeFrame': 'From Week 0 to up to 3 years', 'description': 'The Treatment Satisfaction Questionnaire for Medication (TSQM) is a widely used generic measure to assess treatment satisfaction with their medication. This is a 100-point scale with higher scores indicating greater satisfaction with medication and provides scores on four scales - side effects, effectiveness, convenience and global satisfaction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Plaque Psoriasis Risankizumab Biologics Psoriasis Vulgaris'], 'conditions': ['Chronic Plaque Psoriasis']}, 'referencesModule': {'references': [{'pmid': '39904971', 'type': 'DERIVED', 'citation': 'Thaci D, Ohtsuki M, Maul JT, Szegedi A, Luna PC, Lynde CW, Soliman AM, Wang H, Kaufmann C, Ashley DG, Madihlaba T, Rubant S, Papp KA. Real-World Effectiveness of Risankizumab in Patients with Moderate-to-Severe Psoriasis: Interim Analysis from the VALUE Global Prospective Post-marketing Observational Study at 25 Months. Dermatol Ther (Heidelb). 2025 Feb;15(2):381-394. doi: 10.1007/s13555-025-01342-0. Epub 2025 Feb 4.'}], 'seeAlsoLinks': [{'url': 'https://www.rxabbvie.com/', 'label': 'Related info'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the use of risankizumab in adult patients with moderate to severe chronic plaque psoriasis and compare risankizumab to other commonly used biologics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll adult subjects with moderate to severe plaque psoriasis.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a specialist and presence of moderate to severe psoriasis symptoms according to physician's judgement at time of recruitment.\n* Participant starting any approved treatment for psoriasis and physician's decision must be reached prior to recruitment in the study.\n* Participant willing to continue with study documentation after cessation of therapy.\n\nExclusion Criteria:\n\n* Unwillingness or inability to comply with study requirements.\n* Participation in an interventional clinical trial, concurrently or within the last 30 days. Participation in a post-market observational study (PMOS) or Registry is acceptable."}, 'identificationModule': {'nctId': 'NCT03982394', 'acronym': 'VALUE', 'briefTitle': 'Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Multi-Country Prospective ObserVAtionaL, Cohort Study of Patients With Moderate to Severe Chronic PlaqUE Psoriasis (VALUE)', 'orgStudyIdInfo': {'id': 'P19-377'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants treated with other approved biological therapies', 'description': 'Treatment decision independently made of study enrollment'}, {'label': 'Participants treated with Risankizumab', 'description': 'Treatment decision independently made of study enrollment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1832', 'city': 'Lomas de Zamora', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Emiliano Baccarini Priv Practice /ID# 218581', 'geoPoint': {'lat': -34.7574, 'lon': -58.40279}}, {'zip': '1629', 'city': 'Pilar', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Universitario Austral /ID# 217540', 'geoPoint': {'lat': -34.45867, 'lon': -58.91398}}, {'zip': '1114', 'city': 'Ciudad Autonoma Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Stringa Dermatologia /ID# 218450'}, {'zip': '1425', 'city': 'Ciudad Autonoma Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Private Office Cristina Echeverria /ID# 222082'}, {'zip': '1023', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Stat Research /ID# 217185'}, {'zip': '1055', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Buenos Aires Skin /ID# 217657'}, {'zip': '1425', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'CEDIC Centro de Investigaciones Clinicas /ID# 217184'}, {'zip': '1425', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Instituto de Neumonologia y Dermatologia /ID# 217429'}, {'zip': '1425', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Psoriahue Med Interdisciplinar /ID# 217182'}, {'zip': '1024', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Professional Skin Care /ID# 218514', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1199ABB', 'city': 'CABA', 'country': 'Argentina', 'facility': 'Hospital Italiano /ID# 217000'}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Premier Specialist /ID# 218158', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2228', 'city': 'Miranda', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Kingsway Dermatology & Aesthetics /ID# 217616', 'geoPoint': {'lat': -34.03857, 'lon': 151.10005}}, {'zip': '4032', 'city': 'Chermside', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Northern Dermatology /ID# 218374', 'geoPoint': {'lat': -27.38472, 'lon': 153.03062}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Veracity Clinical Research /ID# 217618', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3053', 'city': 'Carlton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Skin Health Institute Inc /ID# 217619', 'geoPoint': {'lat': -37.8, 'lon': 144.96667}}, {'zip': '6160', 'city': 'Fremantle', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Fremantle Dermatology /ID# 217617', 'geoPoint': {'lat': -32.05632, 'lon': 115.74557}}, {'zip': '8010', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medizinische Universitaet Graz /ID# 217702', 'geoPoint': {'lat': 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'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 213507', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R7A 0L5', 'city': 'Brandon', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'SKIN Clinics /ID# 213082', 'geoPoint': {'lat': 49.84692, 'lon': -99.95306}}, {'zip': 'R3C 0N2', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Winnipeg Clinic /ID# 212134', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E3B 1G9', 'city': 'Fredericton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Dr. Irina Turchin PC Inc. /ID# 212128', 'geoPoint': {'lat': 45.94541, 'lon': -66.66558}}, {'zip': 'A1A 4Y3', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Karma Clinical Trials /ID# 213522', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'A1C 2H5', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'NewLab Clinical Research Inc. /ID# 213521', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'A1E 1V4', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Dr. Brown-Maher PMC INC. /ID# 212136', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'L1S 7K8', 'city': 'Ajax', 'state': 'Ontario', 'country': 'Canada', 'facility': 'CCA Medical Research /ID# 214446', 'geoPoint': {'lat': 43.85012, 'lon': -79.03288}}, {'zip': 'L4M 7G1', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'SimcoDerm Medical and Surgical Dermatology Center /ID# 213081', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'L8L 3C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEADER Research /ID# 249701', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8L 3C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "Lima's Excellence in Allergy and Dermatology Research Inc /ID# 231973", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8L 8E7', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences Corporation /ID# 214053', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8N 1Y2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dermatrials Research /ID# 213523', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L3P 1X2', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lynderm Research Inc /ID# 212124', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'L4W 0C2', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Al-Mohammedi Medicine Professional Corporation /ID# 215408', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L4Y 4C5', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'DermEdge - Queensway East /ID# 213525', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'K1H 7X3', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Angela Montgomery Medicine Professional Corporation /ID# 213615', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K9J 5K2', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr Melinda Gooderham Medicine Professional Corporation /ID# 212133', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'L8G 1H1', 'city': 'Stoney Creek', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Farheen Mussani Medicine Professional Corporation /ID# 213811', 'geoPoint': {'lat': 43.21681, 'lon': -79.76633}}, {'zip': 'M2N 3A6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'North York Research Inc /ID# 213486', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N2J 1C4', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Private Practice 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222685', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '50010', 'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'IPS Universitaria /ID# 241832', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '83001', 'city': 'Soledad', 'state': 'Atlántico', 'country': 'Colombia', 'facility': 'Fundacion Hospital Universidad del Norte /ID# 223428', 'geoPoint': {'lat': 10.91843, 'lon': -74.76459}}, {'zip': '111711', 'city': 'Bogota', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Sociedad de Cirugía de Bogotá- Hospital de San José /ID# 222683'}, {'zip': '110221', 'city': 'Bogotá', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Caja de Compensación Familiar Cafam, Sede Centro de Atención En Salud Cafam Flor /ID# 222660'}, {'zip': '111511', 'city': 'Bogotá', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Centro Dermatológico Federico Lleras Acosta E.S.E /ID# 222686'}, {'zip': '250252', 'city': 'Zipaquirá', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Healthy Medical Center S.A.S /ID# 231909', 'geoPoint': {'lat': 5.02208, 'lon': -74.00481}}, {'zip': '080016', 'city': 'Barranqulla', 'country': 'Colombia', 'facility': 'Ciensalud IPS S.A.S /ID# 244608'}, {'zip': '500 05', 'city': 'Hradec Králové', 'state': 'Hradec Kralove', 'country': 'Czechia', 'facility': 'Fakultní nemocnice Hradec Králové - Sokolská /ID# 222670', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '370 01', 'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Nemocnice Ceske Budejovice a.s. /ID# 216310', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '779 00', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Olomouc /ID# 215901', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '100 34', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Kralovske Vinohrady /ID# 233184', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '110 00', 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