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

NCT ID: NCT06390436

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2029-05-31

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.

Conditions

Uveitis; Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control arm : conventional strategy

At W0, ADA administration will be continued every 14 days. At W24, the control arm will continue to receive ADA every 14 days regardless of serum ADA concentration.

Group Type: ACTIVE_COMPARATOR

Blood sample

Intervention Type: 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

Intervention Type: DRUG

Adalimumab Injection

Arm 2: Interventional arm : adalimumab dose spacing strategy

At W0, if the serum ADA concentration is ≥ 8 μg/mL, ADA administration will be spaced every 21 days. At W24, if the ADA concentration is \< 3.3 μg/mL (having a serum ADA concentration above this threshold was associated with a complete therapeutic response according to one study), administrations will be repeated every 14 days. If the ADA concentration is ≥ 3.3 and \< 8μg/mL, administrations will be left every 21 days. If ADA concentration is still ≥8μg/mL, ADA administrations will be spaced every 28 days.

Group Type: EXPERIMENTAL

Blood sample

Intervention Type: 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

Intervention Type: DRUG

Adalimumab Injection

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Adalimumab Injection

Adalimumab Injection

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Direction Générale de l'Offre de Soins

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucile GRANGE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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

Chu de Saint-Etienne

Saint-Etienne, , France

Countries

France

Central Contacts

Lucile GRANGE, MD

Role: CONTACT

lucile.grange@chu-st-etienne.fr

(0)477828245 ext. +33

Martin KILLIAN, MD

Role: CONTACT

martin.killian@chu-st-etienne.fr

(0)477829179 ext. +33

Facility Contacts

Lucile GRANGE, MD

Role: primary

lucile.grange@chu-st-etienne.fr

(0)477828245 ext. +33

Martin KILLIAN, MD

Role: backup

martin.killian@chu-st-etienne.fr

(0)477829179 ext. +33

Other Identifiers

2023-509733-39-00

Identifier Type: OTHER

Identifier Source: secondary_id

23PH187

Identifier Type: -

Identifier Source: org_study_id