Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT04349956
Status:
TERMINATED
Last Update Posted:
2020-11-17
First Post:
2020-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Term Follow-Up Study of Patients With Osteoarthritis of the Knee Treated With UBX0101 or Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Inability to achieve primary or secondary study objectives', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-13', 'studyFirstSubmitDate': '2020-04-13', 'studyFirstSubmitQcDate': '2020-04-13', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events up to 1 additional year of follow up.', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Painful Osteoarthritis', 'Osteoarthritis, Knee', 'Senescence'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'A follow-up study to assess the long-term safety of intra-articular (IA) administration of UBX0101 in patients with painful knee osteoarthritis (OA).', 'detailedDescription': 'This is a blinded, multi-center study to provide approximately 1 additional year of follow-up for patients with knee OA who participated in a randomized placebo-controlled study of IA UBX0101. No intervention is planned and patients will have 4 scheduled visits to collect follow-up assessments. The primary objective is to evaluate long-term safety and tolerability of IA administration of UBX0101 in patients with painful knee OA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with moderate to severe painful knee OA who participated in a randomized, placebo-controlled study of UBX0101 and who consent to having blinded follow-up at the study site for 1 additional year of follow-up. Patients are permitted to take standard-of-care, background medications for OA.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with knee OA who have completed a randomized placebo-controlled study of UBX0101.\n* Patients who are willing and able to consent to having blinded, long-term follow-up; consent via legally authorized representative is not accepted.\n\nExclusion Criteria:\n\n* Patients with any condition that, in the opinion of the Investigator, would likely interfere with adhering to the study schedule of visits for 12 months.\n* Patients who are scheduled to undergo knee arthroplasty on either knee during the study.\n* Patients who anticipate arthroscopic surgery on either knee at any time during the study.\n* Patients who plan to receive treatment with an anti-nerve growth factor agent during the study.\n* Patients who plan to participate in another investigational study (including interventional studies of investigational drugs and investigational treatments \\[e.g., braces, stem cells, and procedures\\]) during the study.'}, 'identificationModule': {'nctId': 'NCT04349956', 'briefTitle': 'Long-Term Follow-Up Study of Patients With Osteoarthritis of the Knee Treated With UBX0101 or Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Unity Biotechnology, Inc.'}, 'officialTitle': 'Long-Term Follow-Up Study of Patients With Moderate to Severe, Painful Osteoarthritis of the Knee Who Participated in a Randomized, Placebo-Controlled Study of UBX0101', 'orgStudyIdInfo': {'id': 'UBX0101-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients from a randomized placebo-controlled study of UBX0101', 'description': 'Patients with moderate to severe, painful OA of the knee who participated in a randomized, placebo-controlled study of UBX0101.', 'interventionNames': ['Drug: UBX0101 or placebo']}], 'interventions': [{'name': 'UBX0101 or placebo', 'type': 'DRUG', 'description': 'This is an observational study. No intervention is administered.', 'armGroupLabels': ['Patients from a randomized placebo-controlled study of UBX0101']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Coastal Clinical Research, LLC.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Fiel Family and Sports Medicine', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Orthopaedic Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Biosolutions Clinical Research Center', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Well-Pharma Medical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33351', 'city': 'Sunrise', 'state': 'Florida', 'country': 'United States', 'facility': 'Precision Clinical Research', 'geoPoint': {'lat': 26.13397, 'lon': -80.1131}}, {'zip': '32159', 'city': 'The Villages', 'state': 'Florida', 'country': 'United States', 'facility': 'Premier Medical Associates', 'geoPoint': {'lat': 28.93408, 'lon': -81.95994}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Clinical Research Institute', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'The Alliance for Multispecialty Research', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Center for Pharmaceutical Research', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hassman Research Institute', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Albuquerque Clinical Trials', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10530', 'city': 'Hartsdale', 'state': 'New York', 'country': 'United States', 'facility': 'Drug Trials America', 'geoPoint': {'lat': 41.01899, 'lon': -73.79819}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Clinical Research, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '29406', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UNITY Biotechnology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Biotechnology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}