Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
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).
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.
Eligibility
Primary outcome measure(s)
- Cumulative Incidence of Treatment Failure — 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.
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | |
| University of California, Davis | Sacramento | California | |
| University of California, San Francisco | San Francisco | California | |
| University of Miami | Miami | Florida | |
| Children's Mercy Hospital | Kansas City | Missouri | |
| Cincinnati Children's Hospital | Cincinnati | Ohio | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| University of Texas, Austin | Austin | Texas | |
| University of Utah Health | Salt Lake City | Utah | |
| 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 |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07699107 on ClinicalTrials.gov ↗ ← All trials in Italy