Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study ID
NCT06310837
Status
Active Not Recruiting

Conditions

  • Uveitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab Biosimilars Injection — DRUG
    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 — DRUG
    Patients received no less than 1 mg / kg.d glucocorticoid at week 0, then implemented according to the standard reduction scheme.
  • Immunosuppressive Agents — DRUG
    Mycophenolate mofetil 1g bid for more than 3 months, maintenance dose not less than 0.5g bid

Study Details

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.

Key Dates

Start date
Mar 27, 2024
Status verified
May 2025
Primary completion
Oct 31, 2025
Completion
May 1, 2026

Study Design

Enrollment
128 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ADA+MMF group
    Adalimumab biosimilars with immunosuppressants therapy
  • Active Comparator: Corticosteroids+MMF group
    Corticosteroids with immunosuppressive therapy；

Primary Outcome Measure

Change of ETDRS letter count for BCVA at week 24 from baseline [ Time Frame: week 24 ]

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