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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
320
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
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
...and 1 more locations
Maintenance of a complete ophthalmological response at 48 weeks
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+.
Time frame: Week 48
Infection
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.
Time frame: Week 48
Maintenance of a complete ophthalmological response at 12 weeks
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+.
Time frame: Weeks 12
Maintenance of a complete ophthalmological response at 24 weeks
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+.
Time frame: Weeks 24
Maintenance of a complete ophthalmological response at 36 weeks
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+.
Time frame: Weeks 36
Infection
Number of infection during follow-up for up to 12 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.
Time frame: Week 12
Infection
Number of infection during follow-up for up to 24 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.
Time frame: Week 24
Infection
Number of infection during follow-up for up to 36 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.
Time frame: Week 36
Anti-ADA antibody positivity
Anti-ADA antibody positivity by a "drug sensible" test (i-Tracker anti-ADA) in μg/mL
Time frame: Weeks 12
Anti-ADA antibody positivity
Anti-ADA antibody positivity by a "drug sensible" test (i-Tracker anti-ADA) in μg/mL
Time frame: Weeks 24
Anti-ADA antibody positivity
Anti-ADA antibody positivity by a "drug sensible" test (i-Tracker anti-ADA) in μg/mL
Time frame: Weeks 36
Anti-ADA antibody positivity
Anti-ADA antibody positivity by a "drug sensible" test (i-Tracker anti-ADA) in μg/mL
Time frame: Weeks 48
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