[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.

JRCT ID: jRCT2031230402

Registered date:16/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Juvenile Idiopathic Arthritis
• Date of first enrollment: 07/11/2023
• Target sample size: 90
• Countries of recruitment: United States,Japan,Australia,Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

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

Secondary Outcome

- 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

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: < 18age old
• Gender: Both

Include 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 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.

Exclude 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.

Related Information

• Primary Sponsor: Hayato Yamazaki
• Secondary ID(s): NCT05609630