NCT06258915

Treatment FOr Corticosteroid Dependent UveitiS

Randomized Controlled Multicenter Study Comparing Efficacy and Safety of Adalimumab to That of Mycophenolate Mofetil in Steroid Dependent Non-infectious Uveitis

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

FOCUS is the first prospective randomized study comparing standard of care (mycophenolate mofetil) to adalimumab in recently active non infectious uveitis (NIU) with steroid dependency. There is no firm evidence or randomized trials that compared classical immunosuppressive compounds to biological agents; or identified the best treatment in this condition. The burden of NIU has been reduced with the use of immunosuppressive agents and biologics, raising the question of which of these compounds should be preferentially used in recently active NIU with steroid dependency.

Conditions

• Non Infectious Uveitis

Interventions

Type	Name	Description
DRUG	Adalimumab	Adalimumab (80mg at day 0, then 40mg/14 days from W1 to W35 subcutaneously)
DRUG	Mycophenolate Mofetil	2 g/day orally for 36 weeks

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-06-01
• Completion: 2027-11-01
• First posted: 2024-02-14
• Last updated: 2024-02-14