Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-30 @ 10:56 AM
Study NCT ID:
NCT05161234
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2021-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Utility Study of PrismRA for Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-20', 'size': 747705, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-01T13:21', 'hasProtocol': True}, {'date': '2022-11-11', 'size': 1085380, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-01T13:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood will be collected using PrismRA kit consisting of 1 serum separator and 2 PaxGene tubes.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 613}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-01', 'studyFirstSubmitDate': '2021-12-03', 'studyFirstSubmitQcDate': '2021-12-03', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapeutic Response', 'timeFrame': '12-or 24-weeks', 'description': 'Proportion of moderate to severe disease activity patients that achieve measurable clinical outcomes therapeutic response after initiation of a non-csDMARD therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'A clinical utility study for PrismRA testing therapeutic response in patients with rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with RA who will have a PrismRA test completed as part of the trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 at time of consent\n* Patient must meet the criteria for RA as defined by the 2010 ACR/EULAR classification at Visit 1\n* Patient has active, moderate to high, RA with a CDAI of \\>10 at Visit 1\n* Patient has swollen and tender joint count of ≥ 2 each, as determined by CDAI assessment at Visit 1 using a 28-joint count\n* Patient may participate in additional observational studies concurrently\n* Patient is willing and able to complete the informed consent process and comply with study procedures and visit schedule\n\nExclusion Criteria:\n\n* Patients who are unable to understand the protocol and unable to provide informed consent\n* Patients who are not indicated for PrismRA\n* Patients who are receiving concurrent treatment with an investigational therapy or have used an investigational therapy less than 4 weeks prior to Visit 1'}, 'identificationModule': {'nctId': 'NCT05161234', 'acronym': 'DRIVE', 'briefTitle': 'A Clinical Utility Study of PrismRA for Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scipher Medicine'}, 'officialTitle': 'A Clinical Utility Study of PrismRA Testing Therapeutic Response for Rheumatoid Arthritis (DRIVE)', 'orgStudyIdInfo': {'id': 'Scipher-RA-005'}}, 'contactsLocationsModule': {'locations': [{'zip': '85225', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '91722', 'city': 'Covina', 'state': 'California', 'country': 'United States', 'facility': 'Medvin Clinical Research//Covina Arthritis Clinic', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'zip': '92543', 'city': 'Hemet', 'state': 'California', 'country': 'United States', 'facility': 'Southland Arthritis', 'geoPoint': {'lat': 33.74761, 'lon': -116.97307}}, {'zip': '92064', 'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'ACRC Studies', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '91360', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Medvin Clinical Research//Cohen Medical Center', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '91042', 'city': 'Tujunga', 'state': 'California', 'country': 'United States', 'facility': 'Medvin Clinical Research//Foothill Arthritis Clinic', 'geoPoint': {'lat': 34.25223, 'lon': -118.28841}}, {'zip': '91405', 'city': 'Van Nuys', 'state': 'California', 'country': 'United States', 'facility': 'Medvin Clinical Research/Charles Weidmann, Inc.', 'geoPoint': {'lat': 34.18667, 'lon': -118.44897}}, {'zip': '90602', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Medvin Clinical Research//Amicus Arthritis', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '91364', 'city': 'Woodland Hills', 'state': 'California', 'country': 'United States', 'facility': 'Center for Rheumatology Research', 'geoPoint': {'lat': 34.16834, 'lon': -118.60592}}, {'zip': '33825', 'city': 'Avon Park', 'state': 'Florida', 'country': 'United States', 'facility': 'HARAC Research Corp.', 'geoPoint': {'lat': 27.59587, 'lon': -81.50619}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'GNP Research//Mark Jaffe, MD PA', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Clinical Research of Orlando', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '40218', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Rheumatology Associates, PLLC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '71203', 'city': 'Monroe', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Arthritis & Diabetes Clinic, Inc.', 'geoPoint': {'lat': 32.50931, 'lon': -92.1193}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Annapolis Rheumatology', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '21061', 'city': 'Glen Burnie', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mid-Atlantic Rheumatology', 'geoPoint': {'lat': 39.16261, 'lon': -76.62469}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Advanced Rheumatology', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '55121', 'city': 'Eagan', 'state': 'Minnesota', 'country': 'United States', 'facility': 'St. Paul Rheumatology', 'geoPoint': {'lat': 44.80413, 'lon': -93.16689}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Innovative Health Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Arthritis and Osteoporosis Consultants of the Carolinas', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28451', 'city': 'Leland', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cape Fear Arthritis Care', 'geoPoint': {'lat': 34.25628, 'lon': -78.04471}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny Health Network', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29486', 'city': 'Summerville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Low Country Rheumatology', 'geoPoint': {'lat': 33.0185, 'lon': -80.17565}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Wajeeha Yousaf, MD, PA', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '78404', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Adriana Pop Moody MD Clinic PA// Corpus Christi Rheumatology Clinic', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '77089', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Laila Hassan, MD, PA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77494', 'city': 'Katy', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Rheumatology & Arthritis Specialists, PLLC', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Main Rheumatology Associates of South Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77382', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Rheumatology of Houston', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scipher Medicine', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}