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Study identifier: NCT05609630 Synced from ClinicalTrials.gov · July 28, 2026
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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.

Condition: Juvenile Idiopathic Arthritis  ·  Sponsor: AbbVie

PhasePhase 3
Planned participants90
Who can joinAll sexes, 1 Year to 17 Years
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

ABBVIE CALL CENTER  ·  844-663-3742  ·  abbvieclinicaltrials@abbvie.com

Always discuss trial participation with your own doctor first.

Locations (47)

Phoenix Children's Hospital /ID# 253403Phoenix, Arizona, United StatesRecruiting
Childrens National Medical Center /ID# 253344Washington D.C., District of Columbia, United StatesRecruiting
New York Medical College /ID# 253437Valhalla, New York, United StatesRecruiting
Levine Children's Hospital /ID# 253491Charlotte, North Carolina, United StatesCompleted
Cincinnati Childrens Hospital Medical Center /ID# 251827Cincinnati, Ohio, United StatesRecruiting
Randall Children's Hospital /ID# 251829Portland, Oregon, United StatesRecruiting
Instituto CAICI S.R.L /ID# 251448Rosario, Santa Fe Province, ArgentinaRecruiting
Centro de Investigaciones Medicas Tucuman /ID# 251781San Miguel de Tucumán, Tucumán Province, ArgentinaRecruiting
Hospital de Niños de la Santisima Trinidad /ID# 252736Córdoba, ArgentinaRecruiting
Monash Health - Monash Medical Centre - Clayton /ID# 251691Clayton, Victoria, AustraliaCompleted
Royal Children's Hospital /ID# 251663Parkville, Victoria, AustraliaCompleted
Landeskrankenhaus Bregenz /ID# 266317Bregenz, Vorarlberg, AustriaRecruiting

+ 35 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05609630