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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT ETIENNE · Apr 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment strategy for people with chronic non-infectious uveitis (CNUI), a condition that can cause inflammation in the eye and lead to vision problems. The researchers want to see if adjusting the timing of the medication adalimumab (ADA) based on blood level monitoring can help manage the disease effectively while potentially reducing the amount of medication needed. Adalimumab is commonly used for this condition and is typically given every two weeks. The trial aims to find out if spacing out the doses is just as effective for patients who have stable disease.

To be eligible for the trial, participants must be at least 18 years old, have a confirmed diagnosis of CNUI, and have been stable on adalimumab for a certain period. They should also not have used corticosteroids for at least 12 weeks prior to joining the study. Participants will need to sign a consent form and attend follow-up appointments throughout the trial. This research is important because finding a way to safely reduce medication use while still controlling inflammation could improve quality of life for those living with this eye condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.