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NOT YET RECRUITING
NCT07913750
NA

Efficacy and Safety of Adalimumab for the Treatment of Ocular Inflammation

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

Summary

This study aims to evaluate the clinical efficacy and safety of adalimumab in pediatric non-infectious uveitis and to generate domestic real-world evidence (RWE), thereby establishing a clinical foundation for label expansion and reimbursement coverage.

Official title: Efficacy and Safety of Adalimumab in Pediatric Non-Infectious Uveitis: A Multicenter Ambispective Single-Arm Clinical Trial

Key Details

Gender

All

Age Range

2 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-11-15

Completion Date

2028-12-31

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

Adalimumab PFS and Pen

Yuflyma Pen Inj. (recombinant adalimumab biosimilar, Celltrion) is administered via subcutaneous (SC) injection with weight-tiered dosing (\<30 kg: 20 mg; ≥30 kg: 40 mg). * Prospective Treatment-Naïve Cohort: Patients initiating adalimumab receive weight-tiered doses every other week (eow) for 52 weeks. * Retrospective (Switch) Cohort: Patients previously maintained on adalimumab prior to study entry switch to Yuflyma at enrollment and receive weight-tiered maintenance doses once every two weeks (q2w) for at least 12 months.

Locations (1)

Samsung Medical Center

Seoul, South Korea