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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. (SELECT-sJIA)

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Tocilizumab
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring Systemic Juvenile Idiopathic Arthritis, sJIA, Upadacitinib, ABT-494

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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. 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.

Sites / Locations

  • Randall Children's Hospital /ID# 251829Recruiting
  • Monash Children's Hospital /ID# 251691Recruiting
  • Hyogo Prefectural Kobe Children's Hospital /ID# 251649Recruiting
  • St. Marianna University Hospital /ID# 251623Recruiting
  • Niigata University Medical & Dental Hospital /ID# 251538Recruiting
  • Osaka Medical and Pharmaceutical University Hospital /ID# 252092Recruiting
  • Tokyo Medical And Dental University Hospital /ID# 251505Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Cohort 1 Upadacitinib

Cohort 1 Tocilizumab

Cohort 2 Upadacitinib

Arm Description

Participants will receive upadacitinib for 52 weeks.

Participants will receive tocilizumab for 52 weeks.

Participants will receive upadacitinib for 52 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 50 Response
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.
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 70 Response
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.
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 90 Response
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.
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 100 Response
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.
Change from Baseline in Number of Joints with Active Arthritis
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 Number of Joints with Limitation of Motion
Change from Baseline in Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI)
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.
Change From Baseline in Patient's Global Assessment (PtGA)
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.
Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)
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.
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
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.
Percentage of Participants with Absence of fever (> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)
Absence of fever (> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)
Change from Baseline in Glucocorticoid Dose
Change from Baseline in Glucocorticoid Dose
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP)
Juvenile Arthritis Disease Activity Score (JADAS27-CRP) will be assessed
Percentage of Participants Achieving Inactive Disease (ID) Status by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
Inactive Disease (ID) status by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.
Percentage of Participants Achieving Minimal Disease Activity (MDA) by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
Minimal Disease Activity (MDA) by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.
Percentage of Participants Achieving Clinical Remission by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
Clinical Remission by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.

Full Information

First Posted
November 7, 2022
Last Updated
October 4, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05609630
Brief 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.
Acronym
SELECT-sJIA
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
February 28, 2027 (Anticipated)
Study Completion Date
June 7, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
Systemic Juvenile Idiopathic Arthritis, sJIA, Upadacitinib, ABT-494

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 Upadacitinib
Arm Type
Experimental
Arm Description
Participants will receive upadacitinib for 52 weeks.
Arm Title
Cohort 1 Tocilizumab
Arm Type
Active Comparator
Arm Description
Participants will receive tocilizumab for 52 weeks.
Arm Title
Cohort 2 Upadacitinib
Arm Type
Experimental
Arm Description
Participants will receive upadacitinib for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
RINVOQ, ABT-494
Intervention Description
Oral tablet or Oral solution
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
Subcutaneous injection or Intravenous infusion
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response
Description
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%.
Time Frame
At Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 50 Response
Description
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.
Time Frame
Week 12
Title
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 70 Response
Description
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.
Time Frame
Week 12
Title
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 90 Response
Description
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.
Time Frame
Week 12
Title
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 100 Response
Description
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.
Time Frame
Week 12
Title
Change from Baseline in Number of Joints with Active Arthritis
Description
Change from Baseline in Number of Joints with Active Arthritis
Time Frame
Week 12
Title
Change from Baseline in Number of Joints with Limitation of Motion
Description
Change from Baseline in Number of Joints with Limitation of Motion
Time Frame
Week 12
Title
Change from Baseline in Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI)
Description
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.
Time Frame
Week 12
Title
Change From Baseline in Patient's Global Assessment (PtGA)
Description
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.
Time Frame
Week 12
Title
Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)
Description
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.
Time Frame
Week 12
Title
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Description
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.
Time Frame
Week 12
Title
Percentage of Participants with Absence of fever (> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)
Description
Absence of fever (> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)
Time Frame
Week 12
Title
Change from Baseline in Glucocorticoid Dose
Description
Change from Baseline in Glucocorticoid Dose
Time Frame
Week 12
Title
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP)
Description
Juvenile Arthritis Disease Activity Score (JADAS27-CRP) will be assessed
Time Frame
Week 12
Title
Percentage of Participants Achieving Inactive Disease (ID) Status by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
Description
Inactive Disease (ID) status by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.
Time Frame
Week 12
Title
Percentage of Participants Achieving Minimal Disease Activity (MDA) by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
Description
Minimal Disease Activity (MDA) by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.
Time Frame
Week 12
Title
Percentage of Participants Achieving Clinical Remission by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
Description
Clinical Remission by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Randall Children's Hospital /ID# 251829
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227-1654
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
1-503-413-2150
Facility Name
Monash Children's Hospital /ID# 251691
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hyogo Prefectural Kobe Children's Hospital /ID# 251649
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+81-78-945-7300
Facility Name
St. Marianna University Hospital /ID# 251623
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata University Medical & Dental Hospital /ID# 251538
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Medical and Pharmaceutical University Hospital /ID# 252092
City
Takatsuki-shi
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical And Dental University Hospital /ID# 251505
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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, analyses plans, 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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M14-682
Description
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Learn more about this trial

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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