🏛️ Verified NIH Record • Updated 2026-08-13

Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis. (NCT05609630)

A Multicenter, Randomized Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Upadacitinib With a Tocilizumab Reference Arm in Subjects From 1 Year to Less Than 18 Years Old With Active Systemic Juvenile Idiopathic Arthritis

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: AbbVie

🩺 Plain-English Summary (8th-Grade Level)

Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis that affects children. The term "idiopathic" means "of unknown origin". It is a chronic (long-lasting) disease that causes swelling, warmth, and pain of one or more small joints. Systemic JIA ia a rare and serious form of JIA. Systemic" means it may affect not only the joints but other parts of the body, including the liver, lungs and heart. sJIA is more severe and can be more challenging to diagnose and treat than other types of juvenile idiopathic arthritis. It is a lifelong disease for many patients and can continue into adulthood. This study will assess how safe and effective upadacitinib is in treating pediatric and adolescent participants aged 1 to \< 18 with systemic juvenile idiopathic arthritis (sJIA) and will include a tocilizumab treatment arm for reference. Adverse events and change in the disease activity will be assessed. Upadacitinib is an investigational drug being developed for the treatment of sJIA. Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive upadacitinib or tocilizumab reference. In cohort 2, participants will receive upadacitinib. Approximately 90 participants with sJIA will be enrolled in approximately 45 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily or tocilizumab subcutaneous injection or intravenous infusion as per local label for 52 weeks and followed for approximately 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits/calls during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Who can join: Review the eligibility criteria below.

Location: Phoenix Children's Hospital /ID# 253403 — Phoenix, Arizona

Age range: 1 Year to 17 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (48 Sites)

Showing the first 25 of 48 sites.

  • Phoenix Children's Hospital /ID# 253403 — Phoenix, Arizona
  • Childrens National Medical Center /ID# 253344 — Washington D.C., District of Columbia
  • New York Medical College /ID# 253437 — Valhalla, New York
  • Levine Children's Hospital /ID# 253491 — Charlotte, North Carolina
  • Cincinnati Childrens Hospital Medical Center /ID# 251827 — Cincinnati, Ohio
  • Randall Children's Hospital /ID# 251829 — Portland, Oregon
  • Instituto CAICI S.R.L /ID# 251448 — Rosario, Santa Fe Province
  • Centro de Investigaciones Medicas Tucuman /ID# 251781 — San Miguel de Tucumán, Tucumán Province
  • Hospital de Niños de la Santisima Trinidad /ID# 252736 — Córdoba,
  • Monash Health - Monash Medical Centre - Clayton /ID# 251691 — Clayton, Victoria
  • Royal Children's Hospital /ID# 251663 — Parkville, Victoria
  • Landeskrankenhaus Bregenz /ID# 266317 — Bregenz, Vorarlberg
  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769 — Juiz de Fora, Minas Gerais
  • Hospital Sao Paulo /ID# 251765 — São Paulo,
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764 — São Paulo,
  • The Childrens Hospital of Chongqing Medical University /ID# 251539 — Chongqing, Chongqing Municipality
  • Children'S Hospital Of Soochow University /ID# 251755 — Suzhou, Jiangsu
  • Xi'an Children's Hospital /ID# 251693 — Xi'an, Shaanxi
  • Children's Hospital of Fudan University /ID# 251619 — Shanghai, Shanghai Municipality
  • The Children's Hospital of Zhejiang University School of Medicine /ID# 251754 — Hangzhou, Zhejiang
  • Universitaetsklinikum Freiburg /ID# 253288 — Freiburg im Breisgau, Baden-Wurttemberg
  • Asklepios Klinik Sankt Augustin /ID# 251565 — Sankt Augustin, North Rhine-Westphalia
  • St. Josef-Stift Sendenhorst /ID# 268680 — Sendenhorst, North Rhine-Westphalia
  • Helios Klinikum Berlin - Buch /ID# 279847 — Berlin,
  • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564 — Hamburg,

📞 Contact the Study Coordinator

Phone: (844) 663-3742

Email: abbvieclinicaltrials@abbvie.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Juvenile Idiopathic Arthritis

Explore by condition: All Juvenile Idiopathic Arthritis clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗