Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial

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

• Juvenile Idiopathic Arthritis Associated Uveitis
• Uveitis, Anterior

Interventions

BIOLOGICAL

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).

Sponsors & Collaborators

• National Eye Institute (NEI)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• University of California, San Francisco

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Children's Mercy Hospital Kansas City

  collaborator OTHER

• University of Miami

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Texas at Austin

  collaborator OTHER

• Vanderbilt University Medical Center

  collaborator OTHER

• University Hospitals Bristol and Weston NHS Foundation Trust

  collaborator OTHER

• Alder Hey Children's NHS Foundation Trust

  collaborator OTHER

• Great Ormond Street Hospital for Children NHS Foundation Trust

  collaborator OTHER

• Norfolk and Norwich University Hospitals NHS Foundation Trust

  collaborator OTHER

• Manchester University NHS Foundation Trust

  collaborator OTHER_GOV

• Sheffield Children's NHS Foundation Trust

  collaborator OTHER

• University Hospitals, Leicester

  collaborator OTHER

• Meyer Children's Hospital IRCCS

  collaborator OTHER

• Newcastle-upon-Tyne Hospitals NHS Trust

  collaborator OTHER

• Moorfields Eye Hospital NHS Foundation Trust

  collaborator OTHER

• Nisha Acharya

  lead OTHER

Principal Investigators

• Nisha Acharya, MD MS · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2030-05-31

Completion

2030-11-30

FDA Drug

Yes

Countries

• United States
• Italy
• United Kingdom

Study Locations