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Evaluating Upadacitinib and Tocilizumab for Treating Systemic Juvenile Idiopathic Arthritis in Children

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

PHASE3 · AbbVie · NCT05609630

This study is testing whether a new drug called upadacitinib is safe and effective for children and teens with systemic juvenile idiopathic arthritis compared to an existing treatment called tocilizumab.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment90 (estimated)
Ages1 Year to 17 Years
SexAll
SponsorAbbVie (industry)
Drugs / interventionstocilizumab, upadacitinib
Locations44 sites (Phoenix, Arizona and 43 other locations)
Trial IDNCT05609630 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of upadacitinib, an investigational drug, in treating pediatric and adolescent patients aged 1 to under 18 years with active systemic juvenile idiopathic arthritis (sJIA). Participants will receive either upadacitinib or tocilizumab, a reference treatment, and the study will assess changes in disease activity and any adverse events. The trial aims to provide insights into how these drugs move through the body and their impact on this chronic condition.

Who should consider this trial

Good fit: Ideal candidates are pediatric and adolescent patients aged 1 to under 18 years with active sJIA who have not responded adequately to previous treatments.

Not a fit: Patients who have previously been treated with IL-6 inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new effective treatment option for children suffering from systemic juvenile idiopathic arthritis.

How similar studies have performed: Other studies have shown promise in treating juvenile idiopathic arthritis with similar approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

\- Baseline with a total body weight of 10 kg or higher at screening and symptoms of systemic juvenile idiopathic arthritis (sJIA) according to International League of Associations for Rheumatology (ILAR) criteria for at least 6 weeks prior to Screening, with onset prior to 16 years old, and meet the following conditions:

* Must have active sJIA with at least 2 active joints at Screening and Baseline, fever more than 38°C on at least one day within 14 consecutive days before the Screening Visit, and an erythrocyte sedimentation rate (ESR) or high-sensitivity C-reactive protein (hsCRP) \> upper limit of normal (ULN) at Screening. OR At least 4 active joints at Screening and Baseline and an ESR or hsCRP \> ULN at Screening.
* Must have inadequate response to previous treatment with nonsteroidal anti-inflammatory drugs and/or systemic glucocorticoids, as judged by the investigator.
* For Cohort 1, participants must not have had previous treatment with any IL-6 inhibitor. For Cohort 2, participants must have an intolerance or inadequate response to an IL-6 inhibitor as judged by the investigator.

Note: For Cohort 1, participants must be ages 2 to \< 18 years old in countries where SC tocilizumab is not approved for sJIA.

Exclusion Criteria:

* Has any type of juvenile idiopathic arthritis (JIA), other than sJIA, as defined by the ILAR criteria, and must not have a history or presence of any other autoimmune inflammatory condition other than sJIA.
* Has uncontrolled severe systemic disease and/or impeding or active macrophage activation syndrome within 1 month prior to Baseline.

Where this trial is running

Phoenix, Arizona and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis, sJIA, Upadacitinib, ABT-494

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.