Treatment FOr Corticosteroid Dependent UveitiS

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

Qualifiers

Provide written, informed consent prior to the performance of any study-specific procedures

≥18 years of age

Diagnosis of non-infectious intermediate, posterior-, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (Standardization of Uveitis Nomenclature [SUN] criteria) of posterior, or pan- uveitis confirmed by documented medical history

Active chorioretinal or retinal vascular lesion

Disqualifiers

Infectious uveitis, masquerade syndromes (idiopathic uveitis is permitted)

Isolated anterior uveitis

Monocular patient

Active tuberculosis

Trial design

Treatments tested in this trial

  • Adalimumab
  • Mycophenolate Mofetil

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

This trial has no locations