ClinicalTrials.gg
Not yet recruitingNCT07699107ADAPTUpdated Jul 13, 2026

Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial

A Phase 4 interventional study of Adalimumab/Biosimilar in Juvenile Idiopathic Arthritis Associated Uveitis and Uveitis, Anterior, sponsored by Nisha Acharya. Not yet recruiting at 18 sites in 3 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Nisha Acharya · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Juvenile Idiopathic Arthritis Associated Uveitis
  • Uveitis, Anterior

Keywords

  • Adalimumab
  • JIA-associated uveitis
  • Chronic anterior uveitis
  • reduced frequency dosing
03

In context

Uveitis, Anterior

56 studies on the registry are indexed under Uveitis, Anterior; 9 are open to participants now.

This study's planned enrollment of 160 is above the median of 50 across 45 interventional studies indexed under Uveitis, Anterior.

Browse Uveitis, Anterior studies →

Lead sponsor

Nisha Acharya is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Agreement to use highly effective 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

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 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
  • 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, count ≤75000, \<9.0, (AST) or alanine transaminase (ALT) ≥ 2 times the , creatinine ≥1.5
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Active comparator
    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.

    Biological: Adalimumab/Biosimilar

  • Experimental
    4-Week Dose

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

    Biological: Adalimumab/Biosimilar

  • Experimental
    8-Week Dose

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

    Biological: Adalimumab/Biosimilar

  • Experimental
    12-Week Dose

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

    Biological: Adalimumab/Biosimilar

Interventions

  • BiologicalAdalimumab/Biosimilar

    Drug page: Adalimumab

    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

06

What researchers measure

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.

    Time frame: From baseline to 24 weeks post-randomization

07

Study locations

18 sites
08

References and documents

Publications

  • 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. PubMed 29275333 ↗
  • 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. PubMed 37734639 ↗
  • 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. PubMed 28445659 ↗
  • 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. PubMed 39863370 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07699107
Lead sponsor
Nisha Acharya
Collaborators
National Eye Institute (NEI), National Institutes of Health (NIH), University of California, San Francisco, University of California, Davis, University of California, Los Angeles, Children's Hospital Medical Center, Cincinnati, Children's Mercy Hospital Kansas City, University of Miami, University of Utah, University of Texas at Austin, Vanderbilt University Medical Center, University Hospitals Bristol and Weston NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, Manchester University NHS Foundation Trust, Sheffield Children's NHS Foundation Trust, University Hospitals, Leicester, Meyer Children's Hospital IRCCS, Newcastle-upon-Tyne Hospitals NHS Trust, Moorfields Eye Hospital NHS Foundation Trust
Responsible party
Nisha Acharya (Principal Investigator, University of California, San Francisco) — Sponsor-investigator
First posted
Jul 13, 2026
Start date
Sep 2026 (estimated)
Primary completion
May 2030 (estimated)
Completion
Nov 2030 (estimated)
Last update
Jul 13, 2026

Study contacts

Nisha Acharya, MD MS
Contact
Nisha.Acharya@ucsf.edu
415-476-8131
Nisha Acharya, MD MS
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Adalimumab

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