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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.
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
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Oregon
Country [4] 0 0
Brazil
State/province [4] 0 0
Minas Gerais
Country [5] 0 0
Brazil
State/province [5] 0 0
Tocantins
Country [6] 0 0
Brazil
State/province [6] 0 0
Sao Paulo
Country [7] 0 0
China
State/province [7] 0 0
Chongqing
Country [8] 0 0
China
State/province [8] 0 0
Jiangsu
Country [9] 0 0
China
State/province [9] 0 0
Shaanxi
Country [10] 0 0
China
State/province [10] 0 0
Shanghai
Country [11] 0 0
China
State/province [11] 0 0
Zhejiang
Country [12] 0 0
Germany
State/province [12] 0 0
Baden-Wuerttemberg
Country [13] 0 0
Germany
State/province [13] 0 0
Saarland
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Italy
State/province [15] 0 0
Firenze
Country [16] 0 0
Italy
State/province [16] 0 0
Genova
Country [17] 0 0
Japan
State/province [17] 0 0
Hyogo
Country [18] 0 0
Japan
State/province [18] 0 0
Kanagawa
Country [19] 0 0
Japan
State/province [19] 0 0
Niigata
Country [20] 0 0
Japan
State/province [20] 0 0
Osaka
Country [21] 0 0
Japan
State/province [21] 0 0
Tokyo
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Valencia
Country [24] 0 0
Sweden
State/province [24] 0 0
Vastra Gotalands Lan
Country [25] 0 0
Turkey
State/province [25] 0 0
Ankara
Country [26] 0 0
Turkey
State/province [26] 0 0
Istanbul
Country [27] 0 0
United Kingdom
State/province [27] 0 0
London, City Of

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


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