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NOT YET RECRUITING
NCT06258915
PHASE3

Treatment FOr Corticosteroid Dependent UveitiS

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-03-01

Completion Date

2027-11-01

Last Updated

2024-02-14

Healthy Volunteers

No

Interventions

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