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Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
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
Conditions
Interventions
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.
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