Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial

NCT07699107 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 25-45347UG1EY038172
• Study Type: interventional
• Target: 160
• Locations: 3 countries
• Sites: 18

Brief Summary

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.

Conditions

Uveitis, Anterior; Juvenile Idiopathic Arthritis Associated Uveitis

Keywords

Adalimumab; JIA-associated uveitis; Chronic anterior uveitis; reduced frequency dosing

Outcome Measures

Primary Outcomes (1)

• Cumulative Incidence of Treatment Failure

  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

Study Arms (4)

2-Week Dose

ACTIVE COMPARATOR

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.

Biological: Adalimumab/Biosimilar

4-Week Dose

EXPERIMENTAL

Participants receive adalimumab/biosimilar at their current weight-based dose every 4 weeks for 24 weeks.

Biological: Adalimumab/Biosimilar

8-Week Dose

EXPERIMENTAL

Participants receive adalimumab/biosimilar at their current weight-based dose every 8 weeks for 24 weeks.

Biological: Adalimumab/Biosimilar

12-Week Dose

EXPERIMENTAL

Participants receive adalimumab/biosimilar at their current weight-based dose every 12 weeks for 24 weeks.

Biological: Adalimumab/Biosimilar

Interventions

Adalimumab/Biosimilar BIOLOGICAL

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).

Also known as: Humira, Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Simlandi, Yuflyma, Yusimry

12-Week Dose; 2-Week Dose; 4-Week Dose; 8-Week Dose

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (18)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

University of Texas, Austin

Austin, Texas, 78712, United States

Location

University of Utah Health

Salt Lake City, Utah, 84132, United States

Location

Meyer Children's Hospital

Florence, 50139, Italy

Location

University Hospitals Bristol and Weston

Bristol, BS1 3NU, United Kingdom

Location

University Hospitals of Leicester

Leicester, LE1 5WW, United Kingdom

Location

Alder Hey Children's Hospital

Liverpool, L14 5AB, United Kingdom

Location

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Great North Children's Hospital

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, NR4 6TZ, United Kingdom

Location

Sheffield Children's Hospital

Sheffield, S10 2TQ, United Kingdom

Location

Related Publications (4)

• Quartier P, Baptiste A, Despert V, Allain-Launay E, Kone-Paut I, Belot A, Kodjikian L, Monnet D, Weber M, Elie C, Bodaghi B; ADJUVITE Study Group. ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis. Ann Rheum Dis. 2018 Jul;77(7):1003-1011. doi: 10.1136/annrheumdis-2017-212089. Epub 2017 Dec 23.

  PMID: 29275333 BACKGROUND

• Pichi F, Smith SD, Goldstein DA, Baddar D, Gerges TKA, Janetos TM, Ruiz-Cruz M, Elena Concha-Del-Rio L, Maruyama K, Carina Ten Berge J, Rombach SM, Cimino L, Bolletta E, Miserocchi E, Scandale P, Serafino M, Camicione P, Androudi S, Gonzalez-Lopez JJ, Lim LL, Singh N, Gupta V, Gupta N, Amer R, Dodds EM, Inchauspe S, Munk MR, Donicova E, Carreno E, Takeuchi M, Chee SP, Chew MC, Agarwal A, Schlaen A, Gomez RA, Couto CA, Khairallah M, Neri P. The Humira in Ocular Inflammations Taper (HOT) Study. Am J Ophthalmol. 2024 Feb;258:87-98. doi: 10.1016/j.ajo.2023.09.012. Epub 2023 Sep 19.

  PMID: 37734639 BACKGROUND

• Ramanan AV, Dick AD, Jones AP, McKay A, Williamson PR, Compeyrot-Lacassagne S, Hardwick B, Hickey H, Hughes D, Woo P, Benton D, Edelsten C, Beresford MW; SYCAMORE Study Group. Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis. N Engl J Med. 2017 Apr 27;376(17):1637-1646. doi: 10.1056/NEJMoa1614160.

  PMID: 28445659 BACKGROUND

• Acharya NR, Ramanan AV, Coyne AB, Dudum KL, Rubio EM, Woods SM, Guly CM, Moraitis E, Petrushkin HJD, Armon K, Puvanachandra N, Choi JT, Hawley DP, Arnold BF; ADJUST Study Group. Stopping of adalimumab in juvenile idiopathic arthritis-associated uveitis (ADJUST): a multicentre, double-masked, randomised controlled trial. Lancet. 2025 Jan 25;405(10475):303-313. doi: 10.1016/S0140-6736(24)02468-1.

  PMID: 39863370 BACKGROUND

MeSH Terms

Conditions

Uveitis, Anterior; Uveitis, Intermediate

Interventions

Adalimumab; Biosimilar Pharmaceuticals

Condition Hierarchy (Ancestors)

Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Study Officials

• Nisha Acharya, MD MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nisha Acharya, MD MS

CONTACT

415-476-8131; Nisha.Acharya@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (8); US (9); IT (1)