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

ClinicalTrials.gov processed this data on August 12, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified August 2024 by AbbVie

Sponsor

AbbVie

Information Provided by (Responsible Party)

AbbVie

Clinicaltrials.gov Identifier

NCT05609630
Other Study ID Numbers: M14-682
First Submitted: November 7, 2022
First Posted: November 8, 2022
Last Update Posted: August 13, 2024
Last Verified: August 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Juvenile Idiopathic Arthritis
  • Drug: Upadacitinib
  • Drug: Tocilizumab

Study Design

Study TypeInterventional
Anticipated Enrollment90 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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 Start DateOctober 2, 2023
Anticipated Primary Completion DateFebruary 28, 2027
Anticipated Study Completion DateJune 19, 2029

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Cohort 1 Upadacitinib
    • Participants will receive upadacitinib for 52 weeks.
  • Drug: Upadacitinib
    • Oral tablet or Oral solution
  • Cohort 1 Tocilizumab
    • Participants will receive tocilizumab for 52 weeks.
  • Drug: Tocilizumab
    • Cohort 2 Upadacitinib
      • Participants will receive upadacitinib for 52 weeks.
    • Drug: Upadacitinib
      • Oral tablet or Oral solution

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response [At Week 12]
      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

    1. Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 50 Response [Week 12]
      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.
    2. Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 70 Response [Week 12]
      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.
    3. Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 90 Response [Week 12]
      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.
    4. Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 100 Response [Week 12]
      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.
    5. Change from Baseline in Number of Joints with Active Arthritis [Week 12]
      Change from Baseline in Number of Joints with Active Arthritis
    6. Change from Baseline in Number of Joints with Limitation of Motion [Week 12]
      Change from Baseline in Number of Joints with Limitation of Motion
    7. Change from Baseline in Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) [Week 12]
      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.
    8. Change From Baseline in Patient's Global Assessment (PtGA) [Week 12]
      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.
    9. Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA) [Week 12]
      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.
    10. Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) [Week 12]
      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.
    11. Percentage of Participants with Absence of fever (> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA) [Week 12]
      Absence of fever (> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)
    12. Change from Baseline in Glucocorticoid Dose [Week 12]
      Change from Baseline in Glucocorticoid Dose
    13. Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP) [Week 12]
      Juvenile Arthritis Disease Activity Score (JADAS27-CRP) will be assessed
    14. Percentage of Participants Achieving Inactive Disease (ID) Status by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP [Week 12]
      Inactive Disease (ID) status by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.
    15. Percentage of Participants Achieving Minimal Disease Activity (MDA) by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP [Week 12]
      Minimal Disease Activity (MDA) by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.
    16. Percentage of Participants Achieving Clinical Remission by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP [Week 12]
      Clinical Remission by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.

    Eligibility Criteria

    Ages Eligible for Study 1 Year to 17 Years (Child)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    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.

    Contacts and Locations

    Sponsors and Collaborators AbbVie
    Locations
    • New York Medical College /ID# 253437 | Valhalla, New York, United States, 10595
    • Levine Children's Hospital /ID# 253491 | Charlotte, North Carolina, United States, 28203
    • Randall Children's Hospital /ID# 251829 | Portland, Oregon, United States, 97227-1654
    • Monash Medical Centre /ID# 251691 | Clayton, Victoria, Australia, 3168
    • Royal Children's Hospital /ID# 251663 | Parkville, Victoria, Australia, 3052
    • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769 | Juiz de Fora, Minas Gerais, Brazil, 36010-570
    • Hospital Sao Paulo /ID# 251765 | Sao Paulo, Tocantins, Brazil, 04023-062
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764 | Sao Paulo, Brazil, 05403-000
    • The Children's Hospital of Chongqing Medical University /ID# 251539 | Chongqing, Chongqing, China, 400065
    • Children'S Hospital Of Soochow University /ID# 251755 | Suzhou, Jiangsu, China, 215025
    • Xi'an Children's Hospital /ID# 251693 | Xi'an, Shaanxi, China, 710054
    • Children's Hospital of Fudan University /ID# 251619 | Shanghai, Shanghai, China, 200032
    • The Children's Hospital of Zhejiang University School of Medicine /ID# 251754 | Hangzhou, Zhejiang, China, 310003
    • Universitaetsklinikum Freiburg /ID# 253288 | Freiburg, Baden-Wuerttemberg, Germany, 79106
    • Asklepios Klinik Sankt Augustin /ID# 251565 | Sankt Augustin, Saarland, Germany, 53757
    • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564 | Hamburg, Germany, 22081
    • Azienda Ospedaliero Universitaria Meyer /ID# 251775 | Florence, Firenze, Italy, 50139
    • Istituto Giannina Gaslini /ID# 251776 | Genova, L Aquila, Italy, 16147
    • Hyogo Prefectural Kobe Children's Hospital /ID# 251649 | Kobe-shi, Hyogo, Japan, 650-0047
    • St. Marianna University Hospital /ID# 251623 | Kawasaki-shi, Kanagawa, Japan, 216-8511
    • Niigata University Medical & Dental Hospital /ID# 251538 | Niigata-shi, Niigata, Japan, 951-8520
    • Osaka Medical and Pharmaceutical University Hospital /ID# 252092 | Takatsuki-shi, Osaka, Japan, 569-8686
    • Tokyo Medical And Dental University Hospital /ID# 251505 | Bunkyo-ku, Tokyo, Japan, 113-8519
    • Hospital Sant Joan de Deu /ID# 251353 | Esplugues de Llobregat, Barcelona, Spain, 08950
    • Hospital Universitario y Politecnico La Fe /ID# 251352 | Valencia, Spain, 46026
    • Gazi University Medical Faculty /ID# 253677 | Ankara, Turkey, 06560
    • Istanbul University Istanbul Medical Faculty /ID# 251652 | Istanbul, Turkey, 34093
    • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 251651 | Istanbul, Turkey, 34098
    • Great Ormond Street Hospital For Children NHS Foundation Trust /ID# 251512 | London, United Kingdom, WC1N 3JH
    Investigators

      More Information

      Additional Information

      Additional Relevant MeSH Terms

      • Arthritis
      • Arthritis, Juvenile
      • Joint Diseases
      • Musculoskeletal Diseases
      • Rheumatic Diseases
      • Connective Tissue Diseases
      • Autoimmune Diseases
      • Immune System Diseases