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.

Juvenile Idiopathic Arthritis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05609630
• Other study ID #: M14-682
• Secondary ID: 2022-501599-25-0
• Status: Recruiting
• Phase: Phase 3
• Start date: October 2, 2023
• Est. completion date: June 19, 2029

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 19, 2029
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Drug:
• Upadacitinib
Oral tablet or Oral solution
• Tocilizumab
Subcutaneous injection or Intravenous infusion

Locations

Country	Name	City	State
Australia	Monash Medical Centre /ID# 251691	Clayton	Victoria
Australia	Royal Children's Hospital /ID# 251663	Parkville	Victoria
China	The Children's Hospital of Chongqing Medical University /ID# 251539	Chongqing	Chongqing
China	Children's Hospital of Fudan University /ID# 251619	Shanghai	Shanghai
China	Children's Hospital of Soochow University /ID# 251755	Suzhou	Jiangsu
China	Xi'an Children's Hospital /ID# 251693	Xi'an	Shaanxi
Germany	Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564	Hamburg
Germany	Asklepios Klinik Sankt Augustin /ID# 251565	Sankt Augustin
Italy	Azienda Ospedaliero Universitaria Meyer /ID# 251775	Florence	Firenze
Japan	Tokyo Medical And Dental University Hospital /ID# 251505	Bunkyo-ku	Tokyo
Japan	St. Marianna University Hospital /ID# 251623	Kawasaki-shi	Kanagawa
Japan	Hyogo Prefectural Kobe Children's Hospital /ID# 251649	Kobe-shi	Hyogo
Japan	Niigata University Medical & Dental Hospital /ID# 251538	Niigata-shi	Niigata
Japan	Osaka Medical and Pharmaceutical University Hospital /ID# 252092	Takatsuki-shi	Osaka
Spain	Hospital Universitario y Politecnico La Fe /ID# 251352	Valencia
Turkey	Gazi University Medical Faculty /ID# 253677	Ankara
Turkey	Istanbul University Istanbul Medical Faculty /ID# 251652	Istanbul
Turkey	Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 251651	Istanbul
United States	Randall Children's Hospital /ID# 251829	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  China,  Germany,  Italy,  Japan,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	At Week 12
Secondary	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.	Week 12
Secondary	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.	Week 12
Secondary	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.	Week 12
Secondary	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.	Week 12
Secondary	Change from Baseline in Number of Joints with Active Arthritis	Change from Baseline in Number of Joints with Active Arthritis	Week 12
Secondary	Change from Baseline in Number of Joints with Limitation of Motion	Change from Baseline in Number of Joints with Limitation of Motion	Week 12
Secondary	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.	Week 12
Secondary	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.	Week 12
Secondary	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.	Week 12
Secondary	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.	Week 12
Secondary	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)	Week 12
Secondary	Change from Baseline in Glucocorticoid Dose	Change from Baseline in Glucocorticoid Dose	Week 12
Secondary	Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP)	Juvenile Arthritis Disease Activity Score (JADAS27-CRP) will be assessed	Week 12
Secondary	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.	Week 12
Secondary	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.	Week 12
Secondary	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.	Week 12

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