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

Официальное название

Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis: an Open-label, Non-inferiority, Randomised Clinical Trial

Обзор

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.

Подробное описание

There is currently no formal recommendation for spacing ADA administration in patients with chronic noninfectious uveitis, but promising data from a recent retrospective study conducted by the Croix-Rousse team, led to the proposal of a decision support algorithm. Following the example of what has been shown in rheumatoid arthritis, the investigators propose to compare a strategy of spacing ADA administrations in patients with a satisfactory clinical response associated with high serum ADA concentrations.

Вмешательства

• Диагностический тест 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.
• Препарат Adalimumab Injection
  Adalimumab Injection

Первичные конечные точки

• Maintenance of a complete ophthalmological response at 48 weeks [Срок оценки: Week 48]
• Infection [Срок оценки: Week 48]

Вторичные конечные точки (10)

• Maintenance of a complete ophthalmological response at 12 weeks [Срок оценки: Weeks 12]
• Maintenance of a complete ophthalmological response at 24 weeks [Срок оценки: Weeks 24]
• Maintenance of a complete ophthalmological response at 36 weeks [Срок оценки: Weeks 36]
• Infection [Срок оценки: Week 12]
• Infection [Срок оценки: Week 24]
• Infection [Срок оценки: Week 36]
• Anti-ADA antibody positivity [Срок оценки: Weeks 12]
• Anti-ADA antibody positivity [Срок оценки: Weeks 24]
• Anti-ADA antibody positivity [Срок оценки: Weeks 36]
• Anti-ADA antibody positivity [Срок оценки: Weeks 48]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 11 центров

• CH Avignon — Avignon
• Chu Montpied — Clermont-Ferrand
• CHU Grenoble Alpes — Grenoble
• CH Le Puy-en-Velay — Le Puy-en-Velay
• Hôpital de la Croix Rousse — Lyon
• HCL - Hôpital Edouard Herriot — Lyon
• CHU MONTPELLIER - Hôpital Saint-Eloi — Montpellier
• APHP - Centre hospitalier national des Quinze-Vingts — Paris
• … и ещё 3 центра

Идентификаторы

NCT: NCT06390436 · 23PH187 · 2023-509733-39-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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