Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-26 @ 2:27 AM
Study NCT ID:
NCT05240859
Status:
UNKNOWN
Last Update Posted:
2022-02-15
First Post:
2022-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real World Study of a Adalimumab Biosimilar (Geleli) in 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1600}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-06', 'studyFirstSubmitDate': '2022-02-06', 'studyFirstSubmitQcDate': '2022-02-06', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Achieving American College of Rheumatology (ACR) 20', 'timeFrame': 'Week 24', 'description': "The ACR20 was achieved if there was at least a 20% improvement from baseline in swollen joint count 66 (SJC66) and tender joint count 68 (TJC68) and 3 or more of the 5 following assessments: participant's assessment of pain, GH, physician's global assessment of disease activity, participant's assessment of physical function and CRP."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Were on Geleli for a Period of 24 Weeks', 'timeFrame': 'Week 24'}, {'measure': 'Remission rate According to Boolean Criteria', 'timeFrame': 'Week 12 and Week 24'}, {'measure': 'Remission rate According to Clinical Disease Activity Index (CDAI)', 'timeFrame': 'Week 12 and Week 24'}, {'measure': 'Proportion of Participants Achieving American College of Rheumatology (ACR) 20', 'timeFrame': 'Week 4 and Week 12'}, {'measure': 'Proportion of Participants Achieving American College of Rheumatology (ACR) 50', 'timeFrame': 'Week 4, Week 12 and Week 24'}, {'measure': 'Proportion of Participants Achieving American College of Rheumatology (ACR) 70', 'timeFrame': 'Week 4, Week 12 and Week 24'}, {'measure': 'Change From Baseline in Disease Activity Score 28 (DAS28)-ESR', 'timeFrame': 'Baseline, Week 4, Week12 and Week 24'}, {'measure': 'Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)', 'timeFrame': 'Baseline, Week 4, Week12 and Week 24'}, {'measure': 'Assessment of Safety Based on Adverse Events that Occur During the Study.', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this multicenter, prospective, Observational study is to assess the Efficacy and Safety of an Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis in the real world setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'RA patients who start Geleli treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who fulfilled the 1987 revised American College of Rheumatology (ACR) or 2010 ACR/EULAR classification criteria for RA.\n* Participants for whom the rheumatologists have decided to initiate Geleli treatment.\n* Participants who provide a written informed consent form of participating in this study.\n\nExclusion Criteria:\n\n* Current active or chronic infections, or previous history of active TB infection.\n* History of malignancy.\n* Congestive heart failure with NYHA class III or IV.\n* Females of childbearing or breastfeeding.\n* Participate in other clinical trial within 3 months.\n* Allergic to the drugs involved in the study.\n* The investigator believes that the patient is not suitable to participate in this study.'}, 'identificationModule': {'nctId': 'NCT05240859', 'briefTitle': 'Real World Study of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Multicenter, Prospective, Observational Real World Study For the Efficacy and Safety of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis.', 'orgStudyIdInfo': {'id': '2022-Z-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Geleli', 'description': 'RA patients treated with Geleli', 'interventionNames': ['Drug: Geleli']}], 'interventions': [{'name': 'Geleli', 'type': 'DRUG', 'description': 'Adalimumab Biosimilar', 'armGroupLabels': ['Geleli']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Zhanguo Li, MD, PhD', 'role': 'CONTACT', 'email': 'li99@bjmu.edu.cn', 'phone': '+86 88324178'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ru Li, MD, PhD', 'role': 'CONTACT', 'email': 'doctorliru123@163.com', 'phone': '+86 18611616251'}], 'overallOfficials': [{'name': 'Zhanguo Li, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Rheumatology and Immunology, Peking University People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}