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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05609630
Registration number
NCT05609630
Ethics application status
Date submitted
7/11/2022
Date registered
8/11/2022
Titles & IDs
Public title
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.
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Scientific title
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
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Secondary ID [1]
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2022-501599-25-00
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Secondary ID [2]
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M14-682
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Universal Trial Number (UTN)
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Trial acronym
SELECT-sJIA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Tocilizumab
Experimental: Cohort 1 Upadacitinib - Participants will receive upadacitinib for 52 weeks.
Active comparator: Cohort 1 Tocilizumab - Participants will receive tocilizumab for 52 weeks.
Experimental: Cohort 2 Upadacitinib - Participants will receive upadacitinib for 52 weeks.
Treatment: Drugs: Upadacitinib
Oral tablet or Oral solution
Treatment: Drugs: Tocilizumab
Subcutaneous injection or Intravenous infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response
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Assessment method [1]
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ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 30 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of = 30% of the 6 variables of the JIA core set with no more than 1 variable worsening by \> 30%.
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Timepoint [1]
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At Week 12
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Secondary outcome [1]
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Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 50 Response
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Assessment method [1]
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ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 50 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of = 50% of the 6 variables of the JIA core set.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 70 Response
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Assessment method [2]
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ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 70 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of = 70% of the 6 variables of the JIA core set.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 90 Response
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Assessment method [3]
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ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 90 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of = 90% of the 6 variables of the JIA core set.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 100 Response
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Assessment method [4]
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ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 100 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of = 100% of the 6 variables of the JIA core set.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Change from Baseline in Number of Joints with Active Arthritis
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Assessment method [5]
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Change from Baseline in Number of Joints with Active Arthritis
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Change from Baseline in Number of Joints with Limitation of Motion
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Assessment method [6]
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Change from Baseline in Number of Joints with Limitation of Motion
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Change from Baseline in Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI)
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Assessment method [7]
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The CHAQ-DI consists of 30 items and assesses function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 5 response options ranging from no difficulty to unable to do, scored 0 to 3, and not applicable.
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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Change From Baseline in Patient's Global Assessment (PtGA)
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Assessment method [8]
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Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.
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Timepoint [8]
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Week 12
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Secondary outcome [9]
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Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)
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Assessment method [9]
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Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.
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Timepoint [9]
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Week 12
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Secondary outcome [10]
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Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
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Assessment method [10]
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High sensitivity C-reactive protein was analyzed by a central laboratory. The median percent change from baseline in CRP is assessed at each time point.
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Timepoint [10]
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Week 12
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Secondary outcome [11]
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Percentage of Participants with Absence of fever (> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)
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Assessment method [11]
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Absence of fever (\> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)
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Timepoint [11]
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Week 12
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Secondary outcome [12]
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Change from Baseline in Glucocorticoid Dose
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Assessment method [12]
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Change from Baseline in Glucocorticoid Dose
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Timepoint [12]
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Week 12
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Secondary outcome [13]
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Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP)
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Assessment method [13]
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Juvenile Arthritis Disease Activity Score (JADAS27-CRP) will be assessed
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Timepoint [13]
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Week 12
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Secondary outcome [14]
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Percentage of Participants Achieving Inactive Disease (ID) Status by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
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Assessment method [14]
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Inactive Disease (ID) status by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.
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Timepoint [14]
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Week 12
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Secondary outcome [15]
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Percentage of Participants Achieving Minimal Disease Activity (MDA) by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
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Assessment method [15]
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Minimal Disease Activity (MDA) by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.
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Timepoint [15]
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Week 12
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Secondary outcome [16]
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Percentage of Participants Achieving Clinical Remission by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
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Assessment method [16]
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Clinical Remission by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.
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Timepoint [16]
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Week 12
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Eligibility
Key inclusion 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°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.
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Minimum age
1
Year
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/10/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
19/06/2029
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre /ID# 251691 - Clayton
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Recruitment hospital [2]
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Royal Children's Hospital /ID# 251663 - Parkville
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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United States of America
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State/province [2]
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North Carolina
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United States of America
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Oregon
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Country [4]
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Brazil
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State/province [4]
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Minas Gerais
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Brazil
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State/province [5]
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Tocantins
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Brazil
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State/province [6]
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Sao Paulo
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China
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State/province [7]
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Chongqing
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China
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Jiangsu
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Country [9]
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China
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State/province [9]
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Shaanxi
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China
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Shanghai
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China
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Zhejiang
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Germany
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State/province [12]
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Baden-Wuerttemberg
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Germany
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State/province [13]
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Saarland
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Germany
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State/province [14]
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Hamburg
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Italy
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State/province [15]
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Firenze
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Italy
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State/province [16]
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L Aquila
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Japan
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State/province [17]
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Hyogo
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Japan
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State/province [18]
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Kanagawa
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Tokyo
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Spain
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Barcelona
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Spain
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Valencia
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Turkey
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Ankara
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Turkey
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State/province [25]
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Istanbul
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United Kingdom
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State/province [26]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis that affects children. The term "idiopathic" means "of unknown origin". It is a chronic (long-lasting) disease that causes swelling, warmth, and pain of one or more small joints. Systemic JIA ia a rare and serious form of JIA. Systemic" means it may affect not only the joints but other parts of the body, including the liver, lungs and heart. sJIA is more severe and can be more challenging to diagnose and treat than other types of juvenile idiopathic arthritis. It is a lifelong disease for many patients and can continue into adulthood. This study will assess how safe and effective upadacitinib is in treating pediatric and adolescent participants aged 1 to \< 18 with systemic juvenile idiopathic arthritis (sJIA) and will include a tocilizumab treatment arm for reference. Adverse events and change in the disease activity will be assessed. Upadacitinib is an investigational drug being developed for the treatment of sJIA. Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive upadacitinib or tocilizumab reference. In cohort 2, participants will receive upadacitinib. Approximately 90 participants with sJIA will be enrolled in approximately 45 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily or tocilizumab subcutaneous injection or intravenous infusion as per local label for 52 weeks and followed for approximately 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits/calls during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
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Trial website
https://clinicaltrials.gov/study/NCT05609630
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Phone
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Fax
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Email
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Phone
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844-663-3742
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05609630