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. (SELECT-sJIA)
Juvenile Idiopathic Arthritis
About this trial
This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring Systemic Juvenile Idiopathic Arthritis, sJIA, Upadacitinib, ABT-494
Eligibility Criteria
Inclusion Criteria: - Baseline with a total body weight of 10 kg or higher at screening and a diagnosis 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 for any out of 14 consecutive days before the Screening Visit, and an erythrocyte sedimentation rate (ESR) or high-sensitivity C-reactive protein (hsCRP) > 1.5 × upper limit of normal (ULN) at Screening. OR At least 5 active joints at Screening and Baseline and an ESR or hsCRP > 1.5 × ULN at Screening. Must have inadequate response to previous treatment with nonsteroidal anti-inflammatory drugs and 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: Must have 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. Must have uncontrolled severe systemic disease and/or impeding or active macrophage activation syndrome within 3 months prior to Baseline.
Sites / Locations
- Randall Children's Hospital /ID# 251829Recruiting
- Monash Children's Hospital /ID# 251691Recruiting
- Hyogo Prefectural Kobe Children's Hospital /ID# 251649Recruiting
- St. Marianna University Hospital /ID# 251623Recruiting
- Niigata University Medical & Dental Hospital /ID# 251538Recruiting
- Osaka Medical and Pharmaceutical University Hospital /ID# 252092Recruiting
- Tokyo Medical And Dental University Hospital /ID# 251505Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Cohort 1 Upadacitinib
Cohort 1 Tocilizumab
Cohort 2 Upadacitinib
Participants will receive upadacitinib for 52 weeks.
Participants will receive tocilizumab for 52 weeks.
Participants will receive upadacitinib for 52 weeks.