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[M14-682] A Multicenter, Randomized Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Upadacitinib with a Tocilizumab Reference Arm in Subjects from 1 Year to Less than 18 Years Old with Active Systemic Juvenile Idiopathic Arthritis

[M14-682] 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.

Hayato Yamazaki

AbbVie G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Contact for Patients and HCP

AbbVie. G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Recruiting

Nov. 07, 2023

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

- 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 Celsius 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 x upper limit of normal (ULN) at Screening. OR At least 5 active joints at Screening and Baseline and an ESR or hsCRP > 1.5 x 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 subcutaneous 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.

Both

Juvenile Idiopathic Arthritis

Cohort 1 : Upadacitinib (Oral tablet or Oral solution). Participants will receive upadacitinib for 52 weeks.
Cohort 1 : Tocilizumab (Subcutaneous injection or Intravenous infusion). Participants will receive tocilizumab for 52 weeks.
Cohort 2 : Upadacitinib (Oral tablet or Oral solution). Participants will receive upadacitinib for 52 weeks.

Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response

- Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 50 Response
- Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 70 Response
- Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 90 Response
- Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 100 Response
- Change from Baseline in Number of Joints with Active Arthritis
- Change from Baseline in Number of Joints with Limitation of Motion
- Change from Baseline in Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI)
- Change From Baseline in Patient's Global Assessment (PtGA)
- Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)
- Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
- Percentage of Participants with Absence of fever (> 38 Celsius) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)
- Change from Baseline in Glucocorticoid Dose
- Percentage of Participants Achieving Inactive Disease (ID) Status by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
- Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP)
- Percentage of Participants Achieving Minimal Disease Activity (MDA) by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
- Percentage of Participants Achieving Clinical Remission by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP

+81-3-3813-6111

Mar. 28, 2023

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing.html

United States/Australia