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NOT YET RECRUITING
NCT06390436
PHASE4

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

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

View on ClinicalTrials.gov

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.

Official title: Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis: an Open-label, Non-inferiority, Randomised Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2025-06

Completion Date

2029-05

Last Updated

2025-07-01

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Blood sample

A blood sample will be taken, in addition to blood samples taken for the usual follow-up, with 4 dry tubes for the determination of ADA and anti-ADA antibodies and for bio-collection.

DRUG

Adalimumab Injection

Adalimumab Injection

Locations (11)

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