Treatment FOr Corticosteroid Dependent UveitiS

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06258915
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Non Infectious Uveitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Jan 2024
Primary completion
Jun 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab
  • Active Comparator: Mycophenolate mofetil

Primary Outcome Measure

Treatment failure rate [ Time Frame: At week 36 ]

Central Contacts

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