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.
NCT ID: NCT05609630
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
90 participants
INTERVENTIONAL
2023-10-02
2029-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 Upadacitinib
Participants will receive upadacitinib for 52 weeks.
Upadacitinib
Oral tablet or Oral solution
Cohort 1 Tocilizumab
Participants will receive tocilizumab for 52 weeks.
Tocilizumab
Subcutaneous injection or Intravenous infusion
Cohort 2 Upadacitinib
Participants will receive upadacitinib for 52 weeks.
Upadacitinib
Oral tablet or Oral solution
Interventions
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Upadacitinib
Oral tablet or Oral solution
Tocilizumab
Subcutaneous injection or Intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 uncontrolled severe systemic disease and/or impeding or active macrophage activation syndrome within 1 month prior to Baseline.
1 Year
17 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Phoenix Children's Hospital /ID# 253403
Phoenix, Arizona, United States
Childrens National Medical Center /ID# 253344
Washington D.C., District of Columbia, United States
New York Medical College /ID# 253437
Valhalla, New York, United States
Levine Children's Hospital /ID# 253491
Charlotte, North Carolina, United States
Cincinnati Childrens Hospital Medical Center /ID# 251827
Cincinnati, Ohio, United States
Randall Children's Hospital /ID# 251829
Portland, Oregon, United States
Instituto CAICI S.R.L /ID# 251448
Rosario, Santa Fe Province, Argentina
Centro de Investigaciones Medicas Tucuman /ID# 251781
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital de Niños de la Santisima Trinidad /ID# 252736
Córdoba, , Argentina
Monash Health - Monash Medical Centre /ID# 251691
Clayton, Victoria, Australia
Royal Children's Hospital /ID# 251663
Parkville, Victoria, Australia
Landeskrankenhaus Bregenz /ID# 266317
Bregenz, Vorarlberg, Austria
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769
Juiz de Fora, Minas Gerais, Brazil
Hospital Sao Paulo /ID# 251765
São Paulo, , Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764
São Paulo, , Brazil
The Childrens Hospital of Chongqing Medical University /ID# 251539
Chongqing, Chongqing Municipality, China
Children'S Hospital Of Soochow University /ID# 251755
Suzhou, Jiangsu, China
Xi'an Children's Hospital /ID# 251693
Xi'an, Shaanxi, China
Children's Hospital of Fudan University /ID# 251619
Shanghai, Shanghai Municipality, China
The Children's Hospital of Zhejiang University School of Medicine /ID# 251754
Hangzhou, Zhejiang, China
Universitaetsklinikum Freiburg /ID# 253288
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Asklepios Klinik Sankt Augustin /ID# 251565
Sankt Augustin, North Rhine-Westphalia, Germany
St. Josef-Stift Sendenhorst /ID# 268680
Sendenhorst, North Rhine-Westphalia, Germany
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564
Hamburg, , Germany
Semmelweis Egyetem /ID# 266750
Budapest, , Hungary
Azienda Ospedaliero Universitaria Meyer /ID# 251775
Florence, Firenze, Italy
IRCCS Istituto Giannina Gaslini /ID# 251776
Genoa, Genova, Italy
Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 251649
Kobe, Hyōgo, Japan
St Marianna University School Of Medicine /ID# 251623
Kawasaki-shi, Kanagawa, Japan
Niigata University Medical & Dental Hospital /ID# 251538
Niigata, Niigata, Japan
Osaka Medical and Pharmaceutical University Hospital /ID# 252092
Takatsuki-shi, Osaka, Japan
Institute of Science Tokyo Hospital /ID# 251505
Bunkyo-ku, Tokyo, Japan
CREA de Guadalajara SC /ID# 252917
Guadalajara, Jalisco, Mexico
Universitair Medisch Centrum Utrecht /ID# 267435
Utrecht, , Netherlands
Hospital Sant Joan de Deu /ID# 251353
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitario y Politecnico La Fe /ID# 251352
Valencia, , Spain
Queen Silvia Children's Hosp /ID# 251318
Gothenburg, Västra Götaland County, Sweden
National Taiwan University Hospital /ID# 267387
Taipei City, Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 267390
Taoyuan, , Taiwan
Gazi University Medical Faculty /ID# 253677
Ankara, , Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty /ID# 251652
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 251651
Istanbul, , Turkey (Türkiye)
Umraniye Training and Res Hosp /ID# 251653
Istanbul, , Turkey (Türkiye)
Great Ormond Street Children's Hospital /ID# 251512
London, Greater London, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2022-501599-25-00
Identifier Type: OTHER
Identifier Source: secondary_id
M14-682
Identifier Type: -
Identifier Source: org_study_id
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