About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Blood sample
Diagnostic test
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
Drug
Adalimumab Injection

Treatment groups

320 Participants

are divided into 2 treatment groups

Group A: Control arm : conventional strategyActive comparator 2 interventions

Group B: Arm 2: Interventional arm : adalimumab dose spacing strategyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

2

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

Secondary outcomes

1

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

2

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

3

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

4

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

Locations11

Select a site below to view it on the map.

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts