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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Maintenance of a complete ophthalmological response at 48 weeks — Week 48 Number of patient with complete ophthalmological response. Ophtalmological response is defined as number of patient with, in both eyes, absence of inflammatory lesions (0 = absence) AND a cellular grade of the anterior chamber and vitreous ≤ 0.5+.
Infection — Week 48 Number of infection during follow-up for up to 48 weeks. Any suspected infectious event will have to be validated by a healthcare professional based on the presence of suggestive clinical signs (purulent sputum, fever ≥38°C, inflammatory syndrome, positive microbiological examination, etc.) via dedicated forms and validated by an adjudication committee.
Trial sites (11)
Facility
City
Region
Status
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
More Centre Hospitalier Universitaire de Saint Etienne trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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