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NOT YET RECRUITING
NCT07699107
PHASE4

Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial

Sponsor: Nisha Acharya

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-09

Completion Date

2030-11

Last Updated

2026-07-13

Healthy Volunteers

No

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).

Locations (18)

University of California, Los Angeles

Los Angeles, California, United States

University of California, Davis

Sacramento, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Miami

Miami, Florida, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas, Austin

Austin, Texas, United States

University of Utah Health

Salt Lake City, Utah, United States

Meyer Children's Hospital

Florence, Italy

University Hospitals Bristol and Weston

Bristol, United Kingdom

University Hospitals of Leicester

Leicester, United Kingdom

Alder Hey Children's Hospital

Liverpool, United Kingdom

Great Ormond Street Hospital

London, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Great North Children's Hospital

Newcastle upon Tyne, United Kingdom

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Sheffield Children's Hospital

Sheffield, United Kingdom