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.

Launched by ABBVIE · Nov 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two treatments, upadacitinib and tocilizumab, to see how effective they are for children and teens with a serious type of arthritis called systemic juvenile idiopathic arthritis (sJIA). This condition can cause swelling and pain in the joints, and it may also affect other parts of the body. The trial is looking for about 90 participants aged 1 to 17 who have been diagnosed with sJIA and have not responded well to other treatments. To participate, children must weigh at least 10 kg and have specific symptoms related to active sJIA.

Participants in the trial will take either upadacitinib in pill form or receive tocilizumab through an injection or infusion, depending on their assigned group. They will be monitored over a year to check for any side effects and to see how well the treatments work. It's important to know that participants may have more doctor visits than usual, as the study requires regular assessments at a clinic or hospital. This trial aims to improve treatment options for children suffering from this challenging condition.

Gender

ALL

Eligibility 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.