Menu
Not yet recruiting NCT06390436

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

Phase IV Interventional Uveitis Chronic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sample, Adalimumab Injection.
Who it may be relevant to
Registry conditions: Uveitis, Chronic Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Diagnostic test 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.
  • Drug Adalimumab Injection
    Adalimumab Injection

Primary outcome measures

  • Maintenance of a complete ophthalmological response at 48 weeks [Time frame: Week 48]
  • Infection [Time frame: Week 48]
Secondary outcome measures (10)
  • Maintenance of a complete ophthalmological response at 12 weeks [Time frame: Weeks 12]
  • Maintenance of a complete ophthalmological response at 24 weeks [Time frame: Weeks 24]
  • Maintenance of a complete ophthalmological response at 36 weeks [Time frame: Weeks 36]
  • Infection [Time frame: Week 12]
  • Infection [Time frame: Week 24]
  • Infection [Time frame: Week 36]
  • Anti-ADA antibody positivity [Time frame: Weeks 12]
  • Anti-ADA antibody positivity [Time frame: Weeks 24]
  • Anti-ADA antibody positivity [Time frame: Weeks 36]
  • Anti-ADA antibody positivity [Time frame: Weeks 48]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 11 centers
  • 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
  • … and 3 more centers

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗