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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Blood sample
  • Adalimumab Injection

Treatment groups

320 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

Direction Générale de l'Offre de Soins

Collaborator