Clinical Research Directory
Browse clinical research sites, groups, and studies.
Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis
Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Summary
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.
Official title: Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis: A Multicenter, Randomized, Non-inferiority Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2024-03-27
Completion Date
2026-05-01
Last Updated
2025-05-23
Healthy Volunteers
No
Conditions
Interventions
Adalimumab Biosimilars Injection
Adalimumab biosimilars: 80 mg was subcutaneously injected for the first time in the first week, and then 40 mg was subcutaneously injected every two weeks from the first week to the 48 th week.
Corticosteroid
Patients received no less than 1 mg / kg.d glucocorticoid at week 0, then implemented according to the standard reduction scheme.
Immunosuppressive Agents
Mycophenolate mofetil 1g bid for more than 3 months, maintenance dose not less than 0.5g bid
Locations (1)
Shenzhen Eye Hospital
Shenzhen, Guangdong, China