drugset / Trial / NCT06310837
Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis
Active not recruiting
128 enrolled
Zhongshan Ophthalmic Center, Sun Yat-sen University
Shandong Eye Hospital · collabShenzhen Eye Hospital · collabThe Eye Hospital of Wenzhou Medical University · collabThe First Affiliated Hospital of Soochow University · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2024-03-27
- Primary completion
- 2025-10-31
- Completion
- 2026-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Background | Mycophenolate Mofetil | Small molecule | 0.5 g | — |