Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis (NCT06310837) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis
China128 participantsStarted 2024-03-27
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 18 to 70 years old ( including boundary value ), male or female.
✓. At least one eye is diagnosed as noninfectious intermediate uveitis, posterior uveitis or panuveitis.
✓. Subject is on prednisone ≥ 10 mg/day (or corticosteroid equivalent) for at least 2 weeks prior to Screening and remains on the same dose from screening to baseline visit.
✓. At least one eye is diagnosed as active uveitis at baseline；
✓. Subject is voluntary to participate in the study and sign the informed consent form.
Exclusion criteria
✕. Subject with isolated anterior uveitis.
✕. Subject with prior inadequate response to or intolerance to high-dose corticosteroids (equivalent of prednisone 1 mg/kg/day or 60 to 80 mg/day).
✕. Subject is suspected or diagnosed as infectious uveitis.
✕. Uncontrolled glaucoma or high intraocular pressure, defined as intraocular pressure\>25 mmHg after treatment with ≥ 2 anti-glaucoma drugs or evidence of glaucomatous optic nerve injury.
What they're measuring
1
Change of ETDRS letter count for BCVA at week 24 from baseline
Timeframe: week 24
Trial details
NCT IDNCT06310837
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University