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)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Juvenile Idiopathic Arthritis
• Intervention / Treatment: Drug: Upadacitinib; Drug: Tocilizumab

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Argentina
  • Córdoba, Argentina, 5014
    • Recruiting
    • Hospital de Niños de la Santisima Trinidad /ID# 252736
    • Contact: Site Coordinator; Phone Number: 351 458-6405
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Recruiting
      • Instituto CAICI S.R.L /ID# 251448
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Recruiting
      • Centro de Investigaciones Medicas Tucuman /ID# 251781
• Australia
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Completed
      • Monash Health - Monash Medical Centre - Clayton /ID# 251691
    • Parkville, Victoria, Australia, 3052
      • Completed
      • Royal Children's Hospital /ID# 251663
• Austria
  • Vorarlberg
    • Bregenz, Vorarlberg, Austria, 6900
      • Recruiting
      • Landeskrankenhaus Bregenz /ID# 266317
• Brazil
  • São Paulo, Brazil, 04023-062
    • Recruiting
    • Hospital Sao Paulo /ID# 251765
  • São Paulo, Brazil, 05403-000
    • Recruiting
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil, 36010-570
      • Completed
      • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769
• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400065
      • Recruiting
      • The Childrens Hospital of Chongqing Medical University /ID# 251539
  • Jiangsu
    • Suzhou, Jiangsu, China, 215025
      • Recruiting
      • Children'S Hospital Of Soochow University /ID# 251755
  • Shaanxi
    • Xi'an, Shaanxi, China, 710054
      • Recruiting
      • Xi'an Children's Hospital /ID# 251693
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Children's Hospital of Fudan University /ID# 251619
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The Children's Hospital of Zhejiang University School of Medicine /ID# 251754
• Germany
  • Hamburg, Germany, 22081
    • Recruiting
    • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
      • Recruiting
      • Universitaetsklinikum Freiburg /ID# 253288
      • Contact: Site Coordinator; Email: kjk.pedrheum@uniklinik-freiburg.de
  • North Rhine-Westphalia
    • Sankt Augustin, North Rhine-Westphalia, Germany, 53757
      • Recruiting
      • Asklepios Klinik Sankt Augustin /ID# 251565
    • Sendenhorst, North Rhine-Westphalia, Germany, 48324
      • Recruiting
      • St. Josef-Stift Sendenhorst /ID# 268680
• Hungary
  • Budapest, Hungary, 1085
    • Recruiting
    • Semmelweis Egyetem /ID# 266750
• Italy
  • Firenze
    • Florence, Firenze, Italy, 50139
      • Recruiting
      • Azienda Ospedaliero Universitaria Meyer /ID# 251775
  • Genova
    • Genoa, Genova, Italy, 16147
      • Recruiting
      • IRCCS Istituto Giannina Gaslini /ID# 251776
• Japan
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0045
      • Recruiting
      • Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 251649
      • Contact: Site Coordinator; Phone Number: +81-78-945-7300
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 216-8511
      • Recruiting
      • St Marianna University School Of Medicine /ID# 251623
  • Niigata
    • Niigata, Niigata, Japan, 951-8520
      • Recruiting
      • Niigata University Medical and Dental Hospital /ID# 251538
  • Osaka
    • Takatsuki-shi, Osaka, Japan, 569-8686
      • Recruiting
      • Osaka Medical and Pharmaceutical University Hospital /ID# 252092
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Recruiting
      • Institute of Science Tokyo Hospital /ID# 251505
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44620
      • Recruiting
      • CREA de Guadalajara SC /ID# 252917
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • Universitair Medisch Centrum Utrecht /ID# 267435
• Romania
  • Iași, Romania, 700309
    • Not yet recruiting
    • Spitalul Clinic De Urgenta Pentru Copii Sf. Maria /ID# 279813
  • Bucharest
    • Bucharest, Bucharest, Romania, 041451
      • Not yet recruiting
      • Maria Sklodowska Curie Hospital /ID# 282447
  • Timiș County
    • Timișoara, Timiș County, Romania, 300011
      • Not yet recruiting
      • Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu /ID# 279931
• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7700
      • Not yet recruiting
      • Cape Peadiatric Rheumatology /ID# 282533
• Spain
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitario y Politecnico La Fe /ID# 251352
    • Contact: Site Coordinator; Phone Number: +34 961 244 357; Email: reumainf_lafe@gva.es
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Recruiting
      • Hospital Sant Joan de Deu /ID# 251353
• Sweden
  • Jämtland County
    • Östersund, Jämtland County, Sweden, 831 31
      • Not yet recruiting
      • Ostersunds Sjukhus /ID# 281645
  • Skåne County
    • Lund, Skåne County, Sweden, 224 84
      • Not yet recruiting
      • Skane University Hospital Lund /ID# 282573
  • Uppsala County
    • Uppsala, Uppsala County, Sweden, 751 85
      • Not yet recruiting
      • Akademiska Sjukhuset - Uppsala University Hospital /ID# 282653
  • Västra Götaland County
    • Gothenburg, Västra Götaland County, Sweden, 416 85
      • Recruiting
      • Queen Silvia Children's Hosp /ID# 251318
      • Contact: Site Coordinator; Phone Number: +46313435865
• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital /ID# 267387
  • Taoyuan City, Taiwan, 333
    • Recruiting
    • Linkou Chang Gung Memorial Hospital /ID# 267390
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06560
    • Recruiting
    • Gazi University Medical Faculty /ID# 253677
  • Istanbul, Turkey (Türkiye), 34093
    • Recruiting
    • Istanbul University Istanbul Medical Faculty /ID# 251652
  • Istanbul, Turkey (Türkiye), 34098
    • Recruiting
    • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 251651
  • Istanbul, Turkey (Türkiye), 34764
    • Recruiting
    • Umraniye Training and Res Hosp /ID# 251653
• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, WC1N 3HZ
      • Recruiting
      • Great Ormond Street Children's Hospital /ID# 251512
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016-7710
      • Recruiting
      • Phoenix Children's Hospital /ID# 253403
      • Contact: Site Coordinator; Phone Number: 602-933-3822; Email: sgorry@phoenixchildrens.com
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Not yet recruiting
      • Arkansas Children'S Hospital /ID# 278405
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010-2916
      • Recruiting
      • Childrens National Medical Center /ID# 253344
  • Florida
    • Hollywood, Florida, United States, 33021
      • Not yet recruiting
      • Joe Dimaggio Children's Hospital Hollywood /ID# 278992
  • New York
    • Valhalla, New York, United States, 10595
      • Recruiting
      • New York Medical College /ID# 253437
      • Contact: Site Coordinator; Phone Number: 914-504-0152
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Completed
      • Levine Children's Hospital /ID# 253491
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Childrens Hospital Medical Center /ID# 251827
      • Contact: Site Coordinator; Phone Number: 1-513-636-3644; Email: megan.quinlan-waters@cchmc.org
    • Columbus, Ohio, United States, 43205
      • Not yet recruiting
      • Nationwide Children'S Hospital /ID# 278994
  • Oregon
    • Portland, Oregon, United States, 97227-1654
      • Recruiting
      • Randall Children's Hospital /ID# 251829
      • Contact: Site Coordinator; Phone Number: 1-503-413-3508; Email: bbogle@lhs.org
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • UT Health Houston /ID# 278665
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Not yet recruiting
      • Children'S Wisconsin /ID# 278652

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 Upadacitinib; Participants will receive upadacitinib for 52 weeks.	Drug: Upadacitinib; Oral tablet or Oral solution; Other Names: RINVOQ; ABT-494
Active Comparator: Cohort 1 Tocilizumab; Participants will receive tocilizumab for 52 weeks.	Drug: Tocilizumab; Subcutaneous injection or Intravenous infusion
Experimental: Cohort 2 Upadacitinib; Participants will receive upadacitinib for 52 weeks.	Drug: Upadacitinib; Oral tablet or Oral solution; Other Names: RINVOQ; ABT-494

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	Up to Approximately Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Change from Baseline in Number of Joints with Active Arthritis	Change from Baseline in Number of Joints with Active Arthritis	Week 12
Change from Baseline in Number of Joints with Limitation of Motion	Change from Baseline in Number of Joints with Limitation of Motion	Week 12
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
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
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
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
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
Change from Baseline in Glucocorticoid Dose	Change from Baseline in Glucocorticoid Dose	Week 12
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP)	Juvenile Arthritis Disease Activity Score (JADAS27-CRP) will be assessed	Week 12
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Upadacitinib; sJIA; ABT-494; Systemic Juvenile Idiopathic Arthritis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Juvenile; Janus Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; tocilizumab; upadacitinib
• Other Study ID Numbers: M14-682; 2022-501599-25-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• 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