Clinical Trial

Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis

Study acronym: SMOOTH
Not Yet Recruiting Phase 4
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Summary
Uveitis and its complications are thought to account for 10 to 15% of preventable blindness in Western countries. The diagnosis of chronic non-infectious uveitis (CNUI) can be made after exclusion of pseudo uveitis or infectious uveitis, in the case of any persistent uveitis or uveitis with frequent relapses occurring less than 3 months after cessation of treatment. Adalimumab (ADA), an anti-TNFα monoclonal antibody, has marketing authorization and is widely used in the treatment of UCNI as a relay to corticosteroids. The use of ADA has been optimized, in particular through Therapeutic Drug Monitoring (TDM), based on the determination of serum ADA levels and anti-ADA antibodies. Recently, an article showed that a strategy of spacing ADA administrations in RA patients with concentrations \>8 μg/mL was not inferior to standard.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-04-29; most recent amendment 2026-07-09.
Trial Details
NCT Number NCT06390436
Lead Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Direction Générale de l'Offre de Soins
Conditions Uveitis, Chronic Disease
Enrollment 320 participants
Start Date 2026-12
Primary Completion 2029-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-10