EICHORCondition: Uveitis · Chronic Disease · Sponsor: Centre Hospitalier Universitaire de Saint Etienne
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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.
This description comes directly from the study's public registry record.
Lucile GRANGE, MD · (0)477828245 · lucile.grange@chu-st-etienne.fr
Martin KILLIAN, MD · (0)477829179 · martin.killian@chu-st-etienne.fr
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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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 | — |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT06390436