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

Study acronym: SMOOTH
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: May 2028 to Dec 2029 Start date: Jun 2025 to Dec 2026 · Completion date: May 2029 to Dec 2030v7 Show 2 more changesShow less
    • Start date: Jun 2025 to Dec 2026
    • Completion date: May 2029 to Dec 2030
  2. Start date: May 2025 to Jun 2025v6
  3. Primary completion date: Mar 2028 to May 2028 Completion date: Mar 2029 to May 2029 · Start date: Apr 2025 to May 2025v5 Show 2 more changesShow less
    • Completion date: Mar 2029 to May 2029
    • Start date: Apr 2025 to May 2025
  4. Start date: Mar 2025 to Apr 2025v4
  5. Primary completion date: Jan 2028 to Mar 2028 Completion date: Jan 2029 to Mar 2029 · Start date: Jan 2025 to Mar 2025v3 Show 2 more changesShow less
    • Completion date: Jan 2029 to Mar 2029
    • Start date: Jan 2025 to Mar 2025
  6. Study sites: 8 to 11v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov