Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-26 @ 6:54 AM
Study NCT ID:
NCT05155592
Status:
UNKNOWN
Last Update Posted:
2021-12-13
First Post:
2021-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction or Discontinuation of TNF-α Inhibitor in Non-infectious Uveitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-09', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2021-12-09', 'lastUpdatePostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relapse rate of inflammation', 'timeFrame': '24 months', 'description': 'The proportion of the number of uveitis relapse patients during the process of reduction or discontinuation'}], 'secondaryOutcomes': [{'measure': 'Best corrected visual Acuity', 'timeFrame': '24 months', 'description': 'increase of BCVA'}, {'measure': 'macular structure', 'timeFrame': '24 months', 'description': 'Macular thickness (MT). increase of central foveal thickness'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uveitis', 'Adalimumab', 'TNF-α inhibitor'], 'conditions': ['Uveitis', 'Adalimumab']}, 'referencesModule': {'references': [{'pmid': '38652891', 'type': 'DERIVED', 'citation': 'Yuan PD, Hu YW, Chen XQ, Chen GY, Pan Y, Lao HY, Liang D. Adalimumab Dose Reduction and Withdrawal in Stable Non-Infectious Pediatric Uveitis: An Open-Label, Prospective, Pilot Study. Ocul Immunol Inflamm. 2025 Apr;33(3):332-339. doi: 10.1080/09273948.2024.2343084. Epub 2024 Apr 23.'}, {'pmid': '37172782', 'type': 'DERIVED', 'citation': 'Teabagy S, Wood E, Bilsbury E, Doherty S, Janardhana P, Lee DJ. Ocular immunosuppressive microenvironment and novel drug delivery for control of uveitis. Adv Drug Deliv Rev. 2023 Jul;198:114869. doi: 10.1016/j.addr.2023.114869. Epub 2023 May 10.'}]}, 'descriptionModule': {'briefSummary': "TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use can increase the risk of drugs, and the patient's financial burden is large. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.", 'detailedDescription': "TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use will increase the risk of drugs, and the patient's financial burden is large. Previous studies have reported that tapering or discontinuation of Adalimumab may be considered in patients with stable disease. In clinical practice, some important questions about the feasibility of dose reduction in individual patients and the withdrawal plan remain unanswered. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of non-infectious uveitis\n* nflammation was controlled for 6 months after drug remission was achieved using Adalimumab in combination with immunosuppressant therapy\n* Family members and patients who are willing to stop should agree and accept relevant examinations\n* The informed consent is read and signed by the patient or a legally authorized represent\n\nExclusion Criteria:\n\n* Unwilling to sign informed consent\n* There is systemic autoimmune disease uncontrolled situation\n* Patients who may require surgery in the near future\n* Vision meets the standards of low vision and blindness\n* Silicone oil or gas filling after vitreous surgery'}, 'identificationModule': {'nctId': 'NCT05155592', 'briefTitle': 'Reduction or Discontinuation of TNF-α Inhibitor in Non-infectious Uveitis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Study of TNF-α Inhibitor Reduction or Discontinuation in Patients With Non-infectious Uveitis', 'orgStudyIdInfo': {'id': '2021-ADA-Stop'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with inactive uveitis', 'description': 'Patients with non-infectious uveitis whose inflammation reached remission for at least six months after treatment with Adalimumab', 'interventionNames': ['Biological: reduction or discontinuation of Adalimumab']}], 'interventions': [{'name': 'reduction or discontinuation of Adalimumab', 'type': 'BIOLOGICAL', 'description': 'For patients with non-infectious uveitis whose inflammation stabilizes after treated with Adalimumab, extended dosing intervals to once a month, during which inflammatory status is monitored. If there was no recurrence within 6 months, Adalimumab was discontinued, and whether inflammation recurred after withdrawal was observed.', 'armGroupLabels': ['Patients with inactive uveitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dan Liang, PhD', 'role': 'CONTACT', 'email': 'liangd2@mail.sysu.edu.cn', 'phone': '0086-20-87330402'}], 'facility': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Dan Liang, PhD', 'role': 'CONTACT', 'email': 'liangd2@mail.sysu.edu.cn', 'phone': '0086-20-87330402'}], 'overallOfficials': [{'name': 'Dan Liang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dan Liang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Dan Liang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}