Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT05835518
Status:
RECRUITING
Last Update Posted:
2023-05-09
First Post:
2023-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With RA and AS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], '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'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-04-18', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in quality of life (EQ-5D-5L) scores at 52 weeks from baseline in patients with RA and AS', 'timeFrame': '52weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['The Efficacy and Safety of Adalloce'], 'conditions': ['Rheumatoid Arthritis', 'Ankylosing Spondylitis']}, 'descriptionModule': {'briefSummary': 'This Study is to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis, An Observational, Prospective Study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Those diagnosed with RA or AS', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men and women between the ages of over 19 and under 75 at the time of consent\n2. Patients diagnosed with RA or AS at least 3 months prior to the study registration\n3. Patients who are scheduled to be prescribed Adalloce according to the doctor's opinions\n4. Patients who have never received Adalloce\n5. Patients who voluntarily gave their written consent after being sufficiently explained about the purpose and contents of this study\n\nExclusion Criteria:\n\n1. Patients with hypersensitivity to this drug or its components\n2. Patients with active tuberculosis or other severe infection such as sepsis or opportunistic infection\n3. Patients with moderate to severe heart failure (NYHA class III/IV)\n4. Patients who are judged to be inappropriate for Adalloce administration according to the approved conditions\n5. Patients who are not suitable for participation in this study according to the judgment of the investigator\n6. Patients participating in other drug clinical trials (Adalloce PMS participants cannot participate in this study)"}, 'identificationModule': {'nctId': 'NCT05835518', 'briefTitle': 'An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With RA and AS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis', 'orgStudyIdInfo': {'id': 'YMC049'}}, 'contactsLocationsModule': {'locations': [{'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeongyoon Choi', 'role': 'CONTACT'}], 'facility': 'Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'centralContacts': [{'name': 'Hee Suh', 'role': 'CONTACT', 'email': 'hee1110@yuhan.co.kr', 'phone': '+82-2-828-0231'}], 'overallOfficials': [{'name': 'Jeongyoon Choi, PI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daegu Catholic University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}