Last updated 3 months ago
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.
90 patients around the world
Available in Spain, Brazil, United States
AbbVie
1Research sites
90Patients around the world
This study is for people with
Arthritis
Juvenile idiopathic arthritis
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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.
- 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
Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP
Recruiting
StudySELECT-sJIA
SponsorAbbVie
Conditions
Juvenile idiopathic arthritis
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05609630
