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.

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified January 2026 by AbbVie
Sponsor
AbbVie
Information Provided by (Responsible Party)
AbbVie
Clinicaltrials.gov Identifier
NCT05609630
Other Study ID Numbers:
M14-682
First Submitted
November 6, 2022
First Posted
November 7, 2022
Last Update Posted
February 9, 2026
Last Verified
January 2026

ClinicalTrials.gov processed this data on February 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Juvenile Idiopathic Arthritis
Drug: UpadacitinibDrug: TocilizumabDrug: Upadacitinib

Study Design

Study TypeInterventional
Actual 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 1, 2023
Actual Primary Completion Date3yrs 2w from now
Actual Study Completion Date3yrs 2w from now

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
Subcutaneous injection or Intravenous infusion
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
    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%.
  2. Number of Participants with Adverse Events (AEs)
    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Secondary Outcome Measures
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Change from Baseline in Number of Joints with Active Arthritis
    Change from Baseline in Number of Joints with Active Arthritis
  6. Change from Baseline in Number of Joints with Limitation of Motion
    Change from Baseline in Number of Joints with Limitation of Motion
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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)
  12. Change from Baseline in Glucocorticoid Dose
    Change from Baseline in Glucocorticoid Dose
  13. Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP)
    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
    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
    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
    Clinical Remission by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
\- Baseline with a total body weight of 10 kg or higher at screening and symptoms 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 on at least one day within 14 consecutive days before the Screening Visit, and an erythrocyte sedimentation rate (ESR) or high-sensitivity C-reactive protein (hsCRP) \> upper limit of normal (ULN) at Screening. OR At least 4 active joints at Screening and Baseline and an ESR or hsCRP \> ULN at Screening.
Must have inadequate response to previous treatment with nonsteroidal anti-inflammatory drugs and/or 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
Has 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.
Has uncontrolled severe systemic disease and/or impeding or active macrophage activation syndrome within 1 month prior to Baseline.

Contacts and Locations

Sponsors and CollaboratorsAbbVie
Locations
Phoenix Children's Hospital /ID# 253403 | Phoenix Arizona, United States, 85016-7710Childrens National Medical Center /ID# 253344 | Washington D.C. District of Columbia, United States, 20010-2916New York Medical College /ID# 253437 | Valhalla New York, United States, 10595Levine Children's Hospital /ID# 253491 | Charlotte North Carolina, United States, 28203Cincinnati Childrens Hospital Medical Center /ID# 251827 | Cincinnati Ohio, United States, 45229Randall Children's Hospital /ID# 251829 | Portland Oregon, United States, 97227-1654Instituto CAICI S.R.L /ID# 251448 | Rosario Santa Fe Province, Argentina, 2000Centro de Investigaciones Medicas Tucuman /ID# 251781 | San Miguel de Tucumán Tucumán Province, Argentina, 4000Hospital de Niños de la Santisima Trinidad /ID# 252736 | Córdoba , Argentina, 5014Monash Health - Monash Medical Centre /ID# 251691 | Clayton Victoria, Australia, 3168Royal Children's Hospital /ID# 251663 | Parkville Victoria, Australia, 3052Landeskrankenhaus Bregenz /ID# 266317 | Bregenz Vorarlberg, Austria, 6900CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769 | Juiz de Fora Minas Gerais, Brazil, 36010-570Hospital Sao Paulo /ID# 251765 | São Paulo , Brazil, 04023-062Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764 | São Paulo , Brazil, 05403-000The Childrens Hospital of Chongqing Medical University /ID# 251539 | Chongqing Chongqing Municipality, China, 400065Children'S Hospital Of Soochow University /ID# 251755 | Suzhou Jiangsu, China, 215025Xi'an Children's Hospital /ID# 251693 | Xi'an Shaanxi, China, 710054Children's Hospital of Fudan University /ID# 251619 | Shanghai Shanghai Municipality, China, 200032The Children's Hospital of Zhejiang University School of Medicine /ID# 251754 | Hangzhou Zhejiang, China, 310003Universitaetsklinikum Freiburg /ID# 253288 | Freiburg im Breisgau Baden-Wurttemberg, Germany, 79106Asklepios Klinik Sankt Augustin /ID# 251565 | Sankt Augustin North Rhine-Westphalia, Germany, 53757St. Josef-Stift Sendenhorst /ID# 268680 | Sendenhorst North Rhine-Westphalia, Germany, 48324Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564 | Hamburg , Germany, 22081Semmelweis Egyetem /ID# 266750 | Budapest , Hungary, 1085Azienda Ospedaliero Universitaria Meyer /ID# 251775 | Florence Firenze, Italy, 50139IRCCS Istituto Giannina Gaslini /ID# 251776 | Genoa Genova, Italy, 16147Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 251649 | Kobe Hyōgo, Japan, 650-0045St Marianna University School Of Medicine /ID# 251623 | Kawasaki-shi Kanagawa, Japan, 216-8511Niigata University Medical & Dental Hospital /ID# 251538 | Niigata Niigata, Japan, 951-8520Osaka Medical and Pharmaceutical University Hospital /ID# 252092 | Takatsuki-shi Osaka, Japan, 569-8686Institute of Science Tokyo Hospital /ID# 251505 | Bunkyo-ku Tokyo, Japan, 113-8519CREA de Guadalajara SC /ID# 252917 | Guadalajara Jalisco, Mexico, 44620Universitair Medisch Centrum Utrecht /ID# 267435 | Utrecht , Netherlands, 3584 CXHospital Sant Joan de Deu /ID# 251353 | Esplugues de Llobregat Barcelona, Spain, 08950Hospital Universitario y Politecnico La Fe /ID# 251352 | Valencia , Spain, 46026Queen Silvia Children's Hosp /ID# 251318 | Gothenburg Västra Götaland County, Sweden, 416 85National Taiwan University Hospital /ID# 267387 | Taipei , Taiwan, 100Linkou Chang Gung Memorial Hospital /ID# 267390 | Taoyuan City , Taiwan, 333Gazi University Medical Faculty /ID# 253677 | Ankara , Turkey (Türkiye), 06560Istanbul University Istanbul Medical Faculty /ID# 251652 | Istanbul , Turkey (Türkiye), 34093Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 251651 | Istanbul , Turkey (Türkiye), 34098Umraniye Training and Res Hosp /ID# 251653 | Istanbul , Turkey (Türkiye), 34764Great Ormond Street Children's Hospital /ID# 251512 | London Greater London, United Kingdom, WC1N 3HZ
Investigators
Study Director: ABBVIE INC., AbbVie