Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06390436

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Uveitis Chronic Disease Disease Attributes Eye Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CH Avignon, Avignon, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Maintenance of a complete ophthalmological response at 48 weeks

    Time frame: Week 48

    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+.

  2. Infection

    Time frame: Week 48

    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.

Secondary outcomes

  1. Maintenance of a complete ophthalmological response at 12 weeks

    Time frame: Weeks 12

    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+.

  2. Maintenance of a complete ophthalmological response at 24 weeks

    Time frame: Weeks 24

    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+.

  3. Maintenance of a complete ophthalmological response at 36 weeks

    Time frame: Weeks 36

    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+.

  4. Infection

    Time frame: Week 12

    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.

  5. Infection

    Time frame: Week 24

    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.

  6. Infection

    Time frame: Week 36

    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.

  7. Anti-ADA antibody positivity

    Time frame: Weeks 12

    Anti-ADA antibody positivity by a "drug sensible" test (i-Tracker anti-ADA) in μg/mL

  8. Anti-ADA antibody positivity

    Time frame: Weeks 24

    Anti-ADA antibody positivity by a "drug sensible" test (i-Tracker anti-ADA) in μg/mL

  9. Anti-ADA antibody positivity

    Time frame: Weeks 36

    Anti-ADA antibody positivity by a "drug sensible" test (i-Tracker anti-ADA) in μg/mL

  10. Anti-ADA antibody positivity

    Time frame: Weeks 48

    Anti-ADA antibody positivity by a "drug sensible" test (i-Tracker anti-ADA) in μg/mL

Study contacts

Contact information is provided by the study sponsor or research team.

Lucile GRANGE, MD

CONTACT

[email protected]

(0)477828245 ext. +33

Martin KILLIAN, MD

CONTACT

[email protected]

(0)477829179 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Direction Générale de l'Offre de Soins

Registry information

Official study title

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

Acronym: SMOOTH

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Apr 30, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.