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.
- Conditions
- juvenile idiopathic arthritisMedDRA version: 21.0Level: PTClassification code: 10059176Term: Juvenile idiopathic arthritis Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2022-501599-25-00
- Lead Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Subjects and/or their legally authorized representative must be able to understand and be willing to adhere to all protocol requirements and voluntarily sign and date an informed consent (and assent for minors as required by applicable regulation), approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. Demographic and Laboratory Assessments, Male or female subjects, ages 1 to < 18 years old at Baseline. Note: For Cohort 1, subjects must be ages 2 to < 18 years old in countries where SC tocilizumab is not approved for sJIA., Total body weight of 10 kg or higher at the time of Screening., Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug: Serum aspartate transaminase (AST) and alanine aminotransferase (ALT) < 2.0 × upper limit of normal (ULN) for age and sex; Estimated glomerular filtration rate (eGFR) = 60 mL/min/1.73 m2 by modified Schwartz equation for ages < 12 years old, and = 60 mL/min by Cockcroft-Gault equation for ages = 12 years old; Total white blood cell count (WBC) = 3,000/iL; Absolute neutrophil count (ANC) = 2,000/iL; Platelet count = 100,000/iL; Absolute lymphocyte count (ALC) = 750/iL; Hemoglobin = 9 g/dL.
For Cohort 1, subjects must not have had previous treatment with any IL-6 inhibitor. For Cohort 2, subjects must have an intolerance or inadequate response to an IL-6 inhibitor as judged by the investigator., Subjects must not have uncontrolled severe systemic disease and/or impeding or active MAS within 3 months prior to Baseline., Subjects must have inadequate response to previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) and systemic glucocorticoids, as judged by the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method