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Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial (ADAPT)

7 luglio 2026 aggiornato da: Nisha Acharya

The goal of this clinical trial is to learn whether children and young adults with well-controlled juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior uveitis can safely take adalimumab (or biosimilar) injections less often while maintaining control of their disease.

The main question it aims to answer is: can adalimumab/biosimilar injections be given less frequently without uveitis (eye inflammation) or arthritis (joint inflammation) returning?

Researchers will compare adalimumab/biosimilar injection schedules of every 2 weeks, 4 weeks, 8 weeks, and 12 weeks to determine how injection frequency affects disease control.

Participants will:

  • Take adalimumab/biosimilar injections every 2, 4, 8, or 12 weeks.
  • Attend study visits every 6 weeks over 24 weeks, with an additional follow-up visit at 48 weeks for checkups, tests, and questionnaires.
  • Keep a diary of how often they take adalimumab/biosimilar and other drugs they take for their uveitis/arthritis.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

160

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Italia
      • Florence, Italia, 50139
        • Meyer Children's Hospital
        • Investigatore principale:
          • Gabriele Simonini
        • Contatto:
        • Investigatore principale:
          • Ilaria Maccora
  • Regno Unito
      • Bristol, Regno Unito, BS1 3NU
        • University Hospitals Bristol and Weston
        • Investigatore principale:
          • A V Ramanan
        • Contatto:
        • Investigatore principale:
          • Catherine Guly
      • Leicester, Regno Unito, LE1 5WW
        • University Hospitals of Leicester
        • Contatto:
        • Investigatore principale:
          • Arani Sridhar
        • Investigatore principale:
          • Bharat Kapoor
      • Liverpool, Regno Unito, L14 5AB
        • Alder Hey Children's Hospital
        • Investigatore principale:
          • Gavin Cleary
        • Investigatore principale:
          • Jose Gonzalez-Martin
        • Contatto:
      • London, Regno Unito, WC1N 3JH
        • Great Ormond Street Hospital
        • Investigatore principale:
          • Elena Moraitis
        • Investigatore principale:
          • Harry Petrushkin
        • Contatto:
        • Sub-investigatore:
          • Lola Solebo
      • Manchester, Regno Unito, M13 9WL
        • Manchester University NHS Foundation Trust
        • Contatto:
        • Investigatore principale:
          • Jane Ashworth
      • Newcastle upon Tyne, Regno Unito, NE1 4LP
        • Great North Children's Hospital
        • Investigatore principale:
          • Sharmila Jandial
        • Contatto:
      • Norwich, Regno Unito, NR4 6TZ
        • Norfolk and Norwich University Hospital
        • Investigatore principale:
          • Kate Armon
        • Investigatore principale:
          • Narman Puvanachandra
        • Contatto:
      • Sheffield, Regno Unito, S10 2TQ
        • Sheffield Children's Hospital
  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 90095
        • University of California, Los Angeles
        • Investigatore principale:
          • Edmund Tsui, MD
        • Contatto:
      • Sacramento, California, Stati Uniti, 95817
        • University of California, Davis
        • Contatto:
        • Investigatore principale:
          • Parisa Emami-Naeini, MD MPH
        • Investigatore principale:
          • Angel Herrera-Guerra, MD PhD
      • San Francisco, California, Stati Uniti, 94143
        • University of California, San Francisco
        • Investigatore principale:
          • Nisha Acharya, MD
        • Contatto:
        • Sub-investigatore:
          • John Gonzales, MD
        • Sub-investigatore:
          • Thuy Doan, MD PhD
    • Florida
      • Miami, Florida, Stati Uniti, 33136
        • University of Miami
        • Contatto:
        • Investigatore principale:
          • Stephanie Llop, MD
        • Sub-investigatore:
          • Janet Davis, MD
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64108
        • Children's Mercy Hospital
        • Contatto:
        • Investigatore principale:
          • Ashley Cooper, MD
        • Investigatore principale:
          • Erin Stahl, MD
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45229
        • Cincinnati Children's Hospital
        • Investigatore principale:
          • Virginia Miraldi Utz, MD
        • Investigatore principale:
          • Sheila Angeles-Han, MD
        • Contatto:
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37212
        • Vanderbilt University Medical Center
        • Contatto:
        • Investigatore principale:
          • Sapna Gangaputra, MD MPH
        • Investigatore principale:
          • Thomas (Brent) Graham, MD MS
    • Texas
      • Austin, Texas, Stati Uniti, 78712
        • University of Texas, Austin
        • Contatto:
        • Investigatore principale:
          • Eric Crowell, MD MPH
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84132
        • University of Utah Health
        • Contatto:
        • Investigatore principale:
          • Marissa Larochelle, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Stated willingness to comply with all study procedures and availability for the duration of the study period
  • History of juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU), diagnosed prior to 16 years of age (patient may be older than 16 at time of enrollment)
  • ≥2 years of age (per FDA approval for use in children with polyarticular JIA)
  • Weight must be ≥15kg
  • Formal diagnosis of JIA-associated uveitis or CAU with no other suspected etiology
  • ≥24 consecutive months of controlled ocular inflammation (≤0.5+ anterior chamber cell, ≤0.5+ vitreous haze, and no active retinal/choroidal lesions in either eye)
  • ≥24 consecutive months of controlled arthritis verified by a pediatric rheumatologist if defined as JIA-associated uveitis
  • ≥24 consecutive months of treatment with adalimumab or biosimilar of adalimumab
  • ≥180 days on a stable dose of adalimumab or biosimilar of adalimumab; dose must be no greater than 20mg (if weight <30kg), or 40mg (if weight ≥30kg), injected every two weeks
  • If on biosimilar of adalimumab, ≥90 days on the biosimilar
  • Ability to continue to obtain commercial supply of adalimumab or biosimilar
  • If on a conventional disease-modifying anti-rheumatic drug (cDMARD) (injectable or oral methotrexate, mycophenolate mofetil, azathioprine, or leflunomide), dose must be ≤25 mg weekly for methotrexate, ≤3 g daily for mycophenolate mofetil, ≤250 mg daily for azathioprine, or ≤20 mg daily for leflunomide; dose and route of administration must be stable for ≥90 days
  • Willingness to limit consumption of alcohol during the study period
  • Agreement to avoid live attenuated vaccinations
  • Agreement to use highly effective contraception or abstinence for ≥28 days prior to screening and throughout the study period (for males and females of reproductive age)
  • Suitable, in the opinion of the Investigator, to continue treatment with adalimumab/biosimilar per regional labeling

Exclusion Criteria:

  • History of acute anterior uveitis characterized by redness and symptoms, including but not limited to floaters, pain, and light sensitivity
  • Intraocular surgery in the past 90 days or planned surgery in the next 24 weeks
  • Severe cataract or opacity preventing view to the posterior pole in both eyes
  • Chronic hypotony (<5mmHg for ≥90 days) in either eye
  • Treatment with oral corticosteroids or intraocular corticosteroid injection within the last 24 weeks
  • Use of topical corticosteroid eye drops within the last 90 days
  • Use of nonsteroidal anti-inflammatory drug (NSAID) eye drops within the last 90 days
  • Pregnancy or lactation (a pregnancy test will be conducted at baseline and follow-up visits for females post-menarche)
  • Presence of intraretinal or subretinal fluid in either eye
  • Prior safety or tolerability issues with adalimumab
  • History of cancer, active tuberculosis, or hepatitis B
  • Other medical condition expected to dictate treatment course during the study
  • Any of the following laboratory test results on their most recent tests within the past 90 days prior to screening/enrollment: leukocyte count <2500, platelet count ≤75000, hemoglobin<9.0, aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 2 times the upper limit of normal range, creatinine ≥1.5

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 2-Week Dose
Participants receive adalimumab/biosimilar at their current weight-based dose every 2 weeks for 24 weeks, continuing in accordance with current standard of care practice.
Biologico: Adalimumab/Biosimilar
Adalimumab is a fully human monoclonal anti-tumor necrosis factor alpha antibody - a biologic, immunomodulatory drug. Adalimumab (20mg or 40mg) is a clear, colorless solution available as an injectable auto-pen or pre-filled syringe for subcutaneous injection. All FDA-approved adalimumab biosimilars are allowed for this trial and include: Abrilada (adalimumab-afzb), Amjevita (adalimumab-atto), Cyltezo (adalimumab-adbm), Hadlima (adalimumab-bwwd), Hulio (adalimumab-fkjp), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Simlandi (adalimumab-ryvk), Yuflyma (adalimumab-aaty), and Yusimry (adalimumab-aqvh).
Altri nomi:
  • Umira
  • Hyrimoz
  • Idacio
  • Hulio
  • SIMLANDI
  • Abrilada
  • Amjevita
  • Cyltezo
  • Hadlima
  • Yuflyma
  • Yusimry
Sperimentale: 4-Week Dose
Participants receive adalimumab/biosimilar at their current weight-based dose every 4 weeks for 24 weeks.
Biologico: Adalimumab/Biosimilar
Adalimumab is a fully human monoclonal anti-tumor necrosis factor alpha antibody - a biologic, immunomodulatory drug. Adalimumab (20mg or 40mg) is a clear, colorless solution available as an injectable auto-pen or pre-filled syringe for subcutaneous injection. All FDA-approved adalimumab biosimilars are allowed for this trial and include: Abrilada (adalimumab-afzb), Amjevita (adalimumab-atto), Cyltezo (adalimumab-adbm), Hadlima (adalimumab-bwwd), Hulio (adalimumab-fkjp), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Simlandi (adalimumab-ryvk), Yuflyma (adalimumab-aaty), and Yusimry (adalimumab-aqvh).
Altri nomi:
  • Umira
  • Hyrimoz
  • Idacio
  • Hulio
  • SIMLANDI
  • Abrilada
  • Amjevita
  • Cyltezo
  • Hadlima
  • Yuflyma
  • Yusimry
Sperimentale: 8-Week Dose
Participants receive adalimumab/biosimilar at their current weight-based dose every 8 weeks for 24 weeks.
Biologico: Adalimumab/Biosimilar
Adalimumab is a fully human monoclonal anti-tumor necrosis factor alpha antibody - a biologic, immunomodulatory drug. Adalimumab (20mg or 40mg) is a clear, colorless solution available as an injectable auto-pen or pre-filled syringe for subcutaneous injection. All FDA-approved adalimumab biosimilars are allowed for this trial and include: Abrilada (adalimumab-afzb), Amjevita (adalimumab-atto), Cyltezo (adalimumab-adbm), Hadlima (adalimumab-bwwd), Hulio (adalimumab-fkjp), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Simlandi (adalimumab-ryvk), Yuflyma (adalimumab-aaty), and Yusimry (adalimumab-aqvh).
Altri nomi:
  • Umira
  • Hyrimoz
  • Idacio
  • Hulio
  • SIMLANDI
  • Abrilada
  • Amjevita
  • Cyltezo
  • Hadlima
  • Yuflyma
  • Yusimry
Sperimentale: 12-Week Dose
Participants receive adalimumab/biosimilar at their current weight-based dose every 12 weeks for 24 weeks.
Biologico: Adalimumab/Biosimilar
Adalimumab is a fully human monoclonal anti-tumor necrosis factor alpha antibody - a biologic, immunomodulatory drug. Adalimumab (20mg or 40mg) is a clear, colorless solution available as an injectable auto-pen or pre-filled syringe for subcutaneous injection. All FDA-approved adalimumab biosimilars are allowed for this trial and include: Abrilada (adalimumab-afzb), Amjevita (adalimumab-atto), Cyltezo (adalimumab-adbm), Hadlima (adalimumab-bwwd), Hulio (adalimumab-fkjp), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Simlandi (adalimumab-ryvk), Yuflyma (adalimumab-aaty), and Yusimry (adalimumab-aqvh).
Altri nomi:
  • Umira
  • Hyrimoz
  • Idacio
  • Hulio
  • SIMLANDI
  • Abrilada
  • Amjevita
  • Cyltezo
  • Hadlima
  • Yuflyma
  • Yusimry

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cumulative Incidence of Treatment Failure
Lasso di tempo: From baseline to 24 weeks post-randomization

Proportion of participants in each treatment arm experiencing treatment failure by Week 24.

Treatment failure is defined by recurrence of ocular inflammation (at least one of the following in at least one eye):

  • >0.5+ anterior chamber (AC) cell at a single visit as defined by the Standardization of Uveitis Nomenclature (SUN) criteria
  • >0.5+ vitreous haze at a single visit
  • Active retinal/choroidal inflammation and/or macular edema in either eye at a single visit. Macular edema is defined as central subfield thickness on optical coherence tomography (OCT) >2 standard deviations above normal thickness (>320µm on Spectralis or >300µm on Zeiss or Topcon) and having a greater than 20% increase from baseline and/or presence of intraretinal or subretinal fluid.

Treatment failure may also be defined as recurrence of joint disease persistent and severe enough to necessitate unmasking to manage the arthritis recurrence.
From baseline to 24 weeks post-randomization

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Nisha Acharya

Collaboratori

University of California, Los Angeles
University of Miami
National Eye Institute (NEI)
National Institutes of Health (NIH)
University of California, Davis
University of California, San Francisco
Norfolk and Norwich University Hospitals NHS Foundation Trust
Vanderbilt University Medical Center
Children's Hospital Medical Center, Cincinnati
University of Utah
Moorfields Eye Hospital NHS Foundation Trust
University Hospitals, Leicester
Manchester University NHS Foundation Trust
Children's Mercy Hospital Kansas City
Newcastle-upon-Tyne Hospitals NHS Trust
University Hospitals Bristol and Weston NHS Foundation Trust
University of Texas at Austin
Great Ormond Street Hospital for Children NHS Foundation Trust
Alder Hey Children's NHS Foundation Trust
Sheffield Children's NHS Foundation Trust
Meyer Children's Hospital IRCCS

Investigatori

  • Investigatore principale: Nisha Acharya, MD MS, University of California, San Francisco

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 maggio 2030

Completamento dello studio (Stimato)

1 novembre 2030

Date di iscrizione allo studio

Primo inviato

7 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 25-45347
  • UG1EY038172 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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