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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Phoenix Children's Hospital /ID# 253403
  Phoenix, Arizona, United States Recruiting
• Childrens National Medical Center /ID# 253344
  Washington D.C., District of Columbia, United States Recruiting
• Boston Childrens Health Physicians /ID# 253437
  Valhalla, New York, United States Recruiting
• Cincinnati Childrens Hospital Medical Center /ID# 251827
  Cincinnati, Ohio, United States Recruiting
• Randall Children's Hospital /ID# 251829
  Portland, Oregon, United States Recruiting
• Instituto CAICI S.R.L /ID# 251448
  Rosario, Santa Fe Province, Argentina Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.