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

Starting soon · Phase 4

Conditions studied: Uveitis, Chronic Disease

In brief

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.

Key facts

Study ID

NCT06390436

Run by

Centre Hospitalier Universitaire de Saint Etienne

People needed

320

Starts

2026-12-01

Expected to finish

2030-12-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed and having signed the study consent form
• Age ≥ 18 years
• NICU according to the Standardization of Uveitis Nomenclature (SUN) criteria
• Complete ophthalmological response for ≥ 48 weeks (96 weeks for uveitis related to Behçet's disease), all treatments combined
• On ADA 40mg / 14 days for ≥ 24 weeks (i.e. achievement of the steady state for ADA concentrations)
• Not having received systemic corticosteroid therapy for ≥ 12 weeks

You may not qualify if…

• Inability or refusal to understand and/or sign the informed consent form to participate in the study.
• Inability and/or refusal to carry out the follow-up examinations required for the study.
• Modification of any background immunomodulatory treatment (e.g. methotrexate, hydroxychloroquine, mycophenolate, etc.) associated with ADA, during the 12 weeks prior to inclusion.
• Uveitis suspected or proven to be of infectious origin
• Planned surgery (or other foreseeable medical event) requiring discontinuation of ADA for the duration of the study.

Where it is running

• CH Avignon — Avignon, France
• Chu Montpied — Clermont-Ferrand, France
• CHU Grenoble Alpes — Grenoble, France
• CH Le Puy-en-Velay — Le Puy-en-Velay, France
• Hôpital de la Croix Rousse — Lyon, France
• HCL - Hôpital Edouard Herriot — Lyon, France
• CHU MONTPELLIER - Hôpital Saint-Eloi — Montpellier, France
• APHP - Centre hospitalier national des Quinze-Vingts — Paris, France
• APHP - Hôpital Pitié-Salpétrière — Paris, France
• APHP - Hôpital Cochin — Paris, France
• Chu de Saint-Etienne — Saint-Etienne, France

Full record on ClinicalTrials.gov

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