Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis
Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT ETIENNE · Apr 29, 2024
Trial Information
Current as of July 24, 2025
Not yet recruiting
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.
About Centre Hospitalier Universitaire De Saint Etienne
The Centre Hospitalier Universitaire (CHU) de Saint-Étienne is a leading academic medical center in France, dedicated to advancing healthcare through innovative clinical research and high-quality patient care. With a robust infrastructure that supports a wide range of medical specialties, CHU de Saint-Étienne fosters collaboration between healthcare professionals, researchers, and academic institutions. The center is committed to conducting rigorous clinical trials that adhere to ethical standards and regulatory requirements, aiming to improve treatment outcomes and enhance the overall health of the community. Through its dedication to scientific excellence and patient-centered care, CHU de Saint-Étienne plays a pivotal role in the advancement of medical knowledge and the development of new therapeutic interventions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lyon, , France
Avignon, , France
Paris, , France
Clermont Ferrand, , France
Lyon, , France
Grenoble, , France
Saint étienne, , France
Le Puy En Velay, , France
Paris, , France
Paris, , France
Paris, , France
Montpellier, , France
Patients applied
Trial Officials
Lucile GRANGE, MD
Principal Investigator
CHU SAINT-ETIENNE
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported