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ClinicalTrials.gov ID

NCT06390436

Lead Sponsor

Centre Hospitalier Universitaire de Saint EtienneOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

320Estimated

Last Update Posted

Jul 10, 2026Actual

Start Date

Dec 2026Estimated

Primary Completion Date

Dec 2029Estimated

Completion Date

Dec 2030Estimated

Official Title

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

Brief Summary

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.

• Uveitis
• Chronic Disease

• Blood sample
• Adalimumab Injection

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Centre Hospitalier Universitaire de Saint EtienneOTHER

Collaborators

Direction Générale de l'Offre de SoinsOTHER_GOV

lucile.grange@chu-st-etienne.fr(0)477828245 ext. +33