Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT01692912
Status:
WITHDRAWN
Last Update Posted:
2017-04-07
First Post:
2012-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psoriatic Arthritis Treat to Target vs. Usual Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003422', 'term': 'Critical Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-05', 'studyFirstSubmitDate': '2012-09-21', 'studyFirstSubmitQcDate': '2012-09-21', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients achieving low DAS', 'timeFrame': 'Month 9 Visit', 'description': 'The primary outcome measure will be the percentage of patients achieving low Disease Activity Score (DAS\\<2.6) in each patient group (Intensive Care vs. Routine Care) at the end of the study.'}], 'secondaryOutcomes': [{'measure': 'Time to achieving DAS28<2.6', 'timeFrame': 'Month 3 Visit, Month 6 Visit, and Month 9 Visit', 'description': 'Compares the effectiveness of Intensive Care and Routine Care groups, as measured by the time to achieving target of DAS28\\<2.6'}, {'measure': 'Absolute change in DAS28', 'timeFrame': 'Month 3 Visit, Month 6 Visit, Month 9 Visit', 'description': 'To compare the effectiveness of Intensive Care and Routine Care in improving the patient DAS28.'}, {'measure': 'Percentage of Patients achieving ACR 20, 50, and 70', 'timeFrame': 'Month 3 Visit, Month 6 Visit, Month 9 Visit', 'description': 'ACR 20/50/70 defined as:\n\n* 20%, 50%, or 70% reduction in tender joint count, and\n* 20%, 50%, or 70% reduction in swollen joint count, and\n* a 20%, 50%, or 70% reduction in 3 of the following 5 measures:\n* Patient and physician global assessments (VAS)\n* Patient pain score (VAS)\n* HAQ-DI\n* ESR or CRP'}, {'measure': 'Percentage of patients achieving PsARC', 'timeFrame': 'Month 3 Visit, Month 6 Visit, Month 9 Visit', 'description': 'PsARC defined as improvement in at least 2 of the 4 following measures, one of which must be joint swelling or tenderness, and no worsening in any of the 4 measures:\n\n* MDGA (0-5 point scale): reduction by 1 point.\n* PGA (0-5 point scale): reduction by 1 point.\n* TJC (76 or 68): reduction by \\>=30%.\n* SJC (76 or 68): reduction by \\>=30%.'}, {'measure': 'Absolute change in HAQ-DI', 'timeFrame': 'Month 3 Visit, Month 6 Visit, Month 9 Visit', 'description': "HAQ-DI is a self-administered questionnaire using the patient's functional ability during the last week. It consists of 20 items converging to 8 scales measuring dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. The patients rate each activity as 0 = without any difficulty, 1 = some difficulty, 2 = much difficulty and 4 = unable. The final score ranges from 0 to 3 with higher scores indicating more disability."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psoriatic Arthritis', 'Randomized', 'Single blind', 'Treat to target'], 'conditions': ['Psoriatic Arthritis (PsA)']}, 'descriptionModule': {'briefSummary': 'Canadian Rheumatologists will be randomized to treat their participants with active Psoriatic Arthritis to a target (disease activity score \\<2.6), or as per their routine care. The aim of this study is to determine whether treating to a target results in greater disease improvement than treating patients using routine care.', 'detailedDescription': 'Canadian Rheumatologists will be randomized to treat their participants with active Psoriatic Arthritis to a target (disease activity score \\<2.6), or as per their routine care. The aim of this study is to determine whether treating to a target results in greater disease improvement than treating patients using routine care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Psoriatic Arthritis as diagnosed by a rheumatologist and meeting ACR classification criteria for PsA or CASPAR criteria\n* The subject must provide written informed consent for participation in the study before any study specific procedures are performed\n* Subject has 3 or more SJC on 28 joint count\n* Age \\>=18\n\nExclusion Criteria:\n\n* Subject has a history of being non-compliant\n* Serious concomitant illnesses that in the investigator's opinion negate ability to optimally treat the patient\n* If treating with TNF inhibitor, positive PPD \\> 5mm who have not received INH for recommended course or untreated TB (ie CXR evidence of latent infection). Usual screening is in place for standard of care.\n* Pregnancy, breast-feeding or considering pregnancy over the next 12 months"}, 'identificationModule': {'nctId': 'NCT01692912', 'acronym': 'PRC-05-2011', 'briefTitle': 'Psoriatic Arthritis Treat to Target vs. Usual Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pope Research Corporation'}, 'officialTitle': 'A Trial of Active Psoriatic Arthritis (PsA): Randomizing to Treat to a Target vs. Usual Care', 'orgStudyIdInfo': {'id': 'PRC-05-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intensive Care (IC)', 'description': 'Rheumatologists treating to target of DAS28\\<2.6', 'interventionNames': ['Other: Intensive Care']}, {'type': 'NO_INTERVENTION', 'label': 'Routine Care (RC)', 'description': 'Participants treated in the routine manner by their rheumatologist (not treated to the target of DAS28\\<2.6)'}], 'interventions': [{'name': 'Intensive Care', 'type': 'OTHER', 'description': 'Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28\\<2.6', 'armGroupLabels': ['Intensive Care (IC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6G 2S3', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pope Research Corp., 68 Green Acres Drive', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Arthritis Program Research Group', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'M9C 5N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arthur Karasik', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2L 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut de Rheumatologie de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Janet E. Pope, MD, MPH, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Pope Research Corp., University of Western Ontario, St. Joseph's Health Care London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pope Research Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}