protocolSection identificationModule nctId: NCT06310837, orgStudyIdInfo id: 2023KYPJ300, briefTitle: Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2024-08-27, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Zhongshan Ophthalmic Center, Sun Yat-sen University, class: OTHER, collaborators name: The Eye Hospital of Wenzhou Medical University, collaborators name: The First Affiliated Hospital of Soochow University, collaborators name: Shandong Eye Hospital, descriptionModule briefSummary: This is a multi-center, prospective, randomized controlled non-inferior clinical study. A total of 120 subjects with non-infectious intermediate, posterior, or panuveitis were enrolled in Zhongshan Ophthalmic Center and three other centers. They were randomly assigned to the experimental group and the control group according to ( 1 : 1 ). We hypothesized that adalimumab biosimilars combined with immunosuppressive agents in the treatment of non-infectious uveitis is not inferior to glucocorticoids combined with immunosuppressive agents, and there are no additional adverse events and safety issues., conditionsModule conditions: Uveitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Adalimumab Biosimilars Injection, interventions name: Corticosteroid, interventions name: Immunosuppressive Agents, outcomesModule primaryOutcomes measure: Change of ETDRS letter count for BCVA at week 24 from baseline, secondaryOutcomes measure: Proportion of patients with weight gain at week 24 from baseline, secondaryOutcomes measure: Time of treatment failures, secondaryOutcomes measure: Number of treatment failures, secondaryOutcomes measure: Change of Visual Functioning Questionnaire- 25 (VFQ-25) composite score from baseline, secondaryOutcomes measure: Change of anterior chamber inflammation at week 24 from baseline, secondaryOutcomes measure: Change of vitreous opacity at week 24 from baseline, secondaryOutcomes measure: Change of the retinal and choroidal inflammation at week 24 from baseline, secondaryOutcomes measure: Change of the thickness of retina and choroid in macular area at week 24 from baseline, secondaryOutcomes measure: Occurrence of skin abnormalities at the end of study, secondaryOutcomes measure: Occurrence of hypertension at the end of study, secondaryOutcomes measure: Occurrence of hyperglycemia at the end of study, secondaryOutcomes measure: Occurrence of active tuberculosis infection at the end of study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Ophthalmic Center, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Wei Chi, role: CONTACT, phone: 13710616456, email: chiwei@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False