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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05609630




Registration number
NCT05609630
Ethics application status
Date submitted
7/11/2022
Date registered
8/11/2022
Date last updated
4/06/2024

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.
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
Secondary ID [1] 0 0
2022-501599-25-00
Secondary ID [2] 0 0
M14-682
Universal Trial Number (UTN)
Trial acronym
SELECT-sJIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response
Timepoint [1] 0 0
At Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 50 Response
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 70 Response
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 90 Response
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 100 Response
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Change from Baseline in Number of Joints with Active Arthritis
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Change from Baseline in Number of Joints with Limitation of Motion
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Change from Baseline in Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI)
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Change From Baseline in Patient's Global Assessment (PtGA)
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Percentage of Participants with Absence of fever (> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
Change from Baseline in Glucocorticoid Dose
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP)
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
Percentage of Participants Achieving Inactive Disease (ID) Status by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
Timepoint [14] 0 0
Week 12
Secondary outcome [15] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
Timepoint [15] 0 0
Week 12
Secondary outcome [16] 0 0
Percentage of Participants Achieving Clinical Remission by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
Timepoint [16] 0 0
Week 12

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.
Minimum age
1 Year
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/06/2029
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre /ID# 251691 - Clayton
Recruitment hospital [2] 0 0
Royal Children's Hospital /ID# 251663 - Parkville
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Oregon
Country [2] 0 0
Brazil
State/province [2] 0 0
Minas Gerais
Country [3] 0 0
Brazil
State/province [3] 0 0
Sao Paulo
Country [4] 0 0
China
State/province [4] 0 0
Chongqing
Country [5] 0 0
China
State/province [5] 0 0
Jiangsu
Country [6] 0 0
China
State/province [6] 0 0
Shaanxi
Country [7] 0 0
China
State/province [7] 0 0
Shanghai
Country [8] 0 0
Germany
State/province [8] 0 0
Baden-Wuerttemberg
Country [9] 0 0
Germany
State/province [9] 0 0
Hamburg
Country [10] 0 0
Germany
State/province [10] 0 0
Sankt Augustin
Country [11] 0 0
Italy
State/province [11] 0 0
Firenze
Country [12] 0 0
Japan
State/province [12] 0 0
Hyogo
Country [13] 0 0
Japan
State/province [13] 0 0
Kanagawa
Country [14] 0 0
Japan
State/province [14] 0 0
Niigata
Country [15] 0 0
Japan
State/province [15] 0 0
Osaka
Country [16] 0 0
Japan
State/province [16] 0 0
Tokyo
Country [17] 0 0
Spain
State/province [17] 0 0
Valencia
Country [18] 0 0
Turkey
State/province [18] 0 0
Ankara
Country [19] 0 0
Turkey
State/province [19] 0 0
Istanbul
Country [20] 0 0
United Kingdom
State/province [20] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05609630
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05609630