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Not yet recruitingPhase 4

Blood-level-guided adalimumab dose reduction in long-lasting non-infectious uveitis

Tests spacing out adalimumab, guided by blood levels, in adults with chronic non-infectious uveitis.

Key facts

Who runs it
Centre Hospitalier Universitaire de Saint Etienne
Where
France10 sites in 1 countryChoose a country to see its sites
Registry title
Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis
Status
Not yet recruiting
Phase
Phase 4
People taking part
320 people, planned
Starts
Dec 2026
Expected to end
Dec 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Blood sample
  • Adalimumab Injection
Record updated
10 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-lasting uveitis (eye inflammation) not caused by infection. Their uveitis must be fully controlled while they take adalimumab (ADA).

Age
18 years or older
Sex
All sexes
Disease stage
Chronic non-infectious uveitis by the SUN criteria. The eye must have responded fully for at least 48 weeks (96 weeks for uveitis linked to Behçet's disease).
Earlier treatment
Must be on ADA 40mg every 14 days for at least 24 weeks. Must not have had corticosteroids by mouth or injection (systemic) for at least 12 weeks.

Main reasons for not taking part

  • Uveitis that is suspected or proven to come from an infection
  • A change to other immune treatments taken with ADA (such as methotrexate, hydroxychloroquine, mycophenolate) in the 12 weeks before joining
  • Planned surgery or other expected medical event that would need ADA to stop during the study
  • Unable or unwilling to do the follow-up visits
  • Unable or unwilling to understand or sign the consent form

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Modification of any background immunomodulatory treatment (e.g. methotrexate, hydroxychloroquine, mycophenolate, etc.) associated with ADA, during the 12 weeks prior to inclusion
  • Planned surgery (or other foreseeable medical event) requiring discontinuation of ADA for the duration of the study
  • 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
  • Uveitis suspected or proven to be of infectious origin

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Control arm : conventional strategyExisting treatment, for comparison

    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.

    Treatment: Blood sample and Adalimumab Injection

  • Arm 2: Interventional arm : adalimumab dose spacing strategyTreatment being tested

    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.

    Treatment: Blood sample and Adalimumab Injection

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis: an Open-label, Non-inferiority, Randomised Clinical Trial
Plain-language title
Blood-level-guided adalimumab dose reduction in long-lasting non-infectious uveitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
10 July 2026