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

• Juvenile Idiopathic Arthritis Associated Uveitis
• Uveitis, Anterior

Intervention / Treatment

• Biological: Adalimumab/Biosimilar

Primary Outcome Measures

• 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.

Countries

Italy, United Kingdom, United States

Locations and Investigators

• University of California, Los Angeles, Los Angeles, United States
  • Edmund Tsui, MD
  • Edmund Tsui, MD (Principal Investigator)
• University of California, Davis, Sacramento, United States
  • Parisa Emami-Naeini, MD, MPH
  • Parisa Emami-Naeini, MD MPH (Principal Investigator)
  • Angel Herrera-Guerra, MD PhD (Principal Investigator)
• University of California, San Francisco, San Francisco, United States
  • Nisha Acharya, MD MS
  • Nisha Acharya, MD (Principal Investigator)
  • Thuy Doan, MD PhD
  • John Gonzales, MD
• University of Miami, Miami, United States
  • Stephanie Llop, MD
  • Stephanie Llop, MD (Principal Investigator)
  • Janet Davis, MD
• Children's Mercy Hospital, Kansas City, United States
  • Erin Stahl, MD
  • Erin Stahl, MD (Principal Investigator)
  • Ashley Cooper, MD (Principal Investigator)
• Cincinnati Children's Hospital, Cincinnati, United States
  • Sheila Angeles-Han, MD
  • Sheila Angeles-Han, MD (Principal Investigator)
  • Virginia Miraldi Utz, MD (Principal Investigator)
• Vanderbilt University Medical Center, Nashville, United States
  • Sapna Gangaputra, MD MPH
  • Sapna Gangaputra, MD MPH (Principal Investigator)
  • Thomas (Brent) Graham, MD MS (Principal Investigator)
• University of Texas, Austin, Austin, United States
  • Eric Crowell, MD MPH
  • Eric Crowell, MD MPH (Principal Investigator)
• University of Utah Health, Salt Lake City, United States
  • Marissa Larochelle, MD
  • Marissa Larochelle, MD (Principal Investigator)
• Meyer Children's Hospital, Florence, Italy
  • Gabriele Simonini
  • Gabriele Simonini (Principal Investigator)
  • Ilaria Maccora (Principal Investigator)
• University Hospitals Bristol and Weston, Bristol, United Kingdom
  • A V Ramanan
  • A V Ramanan (Principal Investigator)
  • Catherine Guly (Principal Investigator)
• University Hospitals of Leicester, Leicester, United Kingdom
  • Arani Sridhar
  • Arani Sridhar (Principal Investigator)
  • Bharat Kapoor (Principal Investigator)
• Alder Hey Children's Hospital, Liverpool, United Kingdom
  • Jose Gonzalez-Martin
  • Jose Gonzalez-Martin (Principal Investigator)
  • Gavin Cleary (Principal Investigator)
• Great Ormond Street Hospital, London, United Kingdom
  • Elena Moraitis
  • Elena Moraitis (Principal Investigator)
  • Harry Petrushkin (Principal Investigator)
  • Lola Solebo
• Manchester University NHS Foundation Trust, Manchester, United Kingdom
  • Jane Ashworth
  • Jane Ashworth (Principal Investigator)
• Great North Children's Hospital, Newcastle upon Tyne, United Kingdom
  • Sharmila Jandial
  • Sharmila Jandial (Principal Investigator)
• Norfolk and Norwich University Hospital, Norwich, United Kingdom
  • Narman Puvanachandra
  • Narman Puvanachandra (Principal Investigator)
  • Kate Armon (Principal Investigator)
• Sheffield Children's Hospital, Sheffield, United Kingdom

Study Officials

• Nisha Acharya, MD MS (Principal Investigator) — University of California, San Francisco