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.

Last updated: February 19, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Rheumatoid Arthritis (Pediatric)

Musculoskeletal Diseases

Arthritis And Arthritic Pain (Pediatric)

Treatment

Tocilizumab

Upadacitinib

Clinical Study ID

NCT05609630
M14-682
2022-501599-25-00
  • Ages 1-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Baseline with a total body weight of 10 kg or higher at screening and symptoms ofsystemic juvenile idiopathic arthritis (sJIA) according to International League ofAssociations for Rheumatology (ILAR) criteria for at least 6 weeks prior toScreening, 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, fevermore than 38°C on at least one day within 14 consecutive days before the ScreeningVisit, and an erythrocyte sedimentation rate (ESR) or high-sensitivity C-reactiveprotein (hsCRP) > upper limit of normal (ULN) at Screening. OR At least 4 activejoints at Screening and Baseline and an ESR or hsCRP > ULN at Screening.

  • Must have inadequate response to previous treatment with nonsteroidalanti-inflammatory drugs and/or systemic glucocorticoids, as judged by theinvestigator.

  • For Cohort 1, participants must not have had previous treatment with any IL-6inhibitor. For Cohort 2, participants must have an intolerance or inadequateresponse 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

Exclusion Criteria:

  • Has any type of juvenile idiopathic arthritis (JIA), other than sJIA, as defined bythe ILAR criteria, and must not have a history or presence of any other autoimmuneinflammatory condition other than sJIA.

  • Has uncontrolled severe systemic disease and/or impeding or active macrophageactivation syndrome within 1 month prior to Baseline.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Tocilizumab
Phase: 3
Study Start date:
October 02, 2023
Estimated Completion Date:
June 30, 2029

Connect with a study center

  • Monash Children's Clinical Trials Centre /ID# 251691

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Children's Hospital /ID# 251691

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Health - Monash Medical Centre /ID# 251691

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Medical Centre /ID# 251691

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Royal Children's Hospital /ID# 251663

    Parkville, Victoria 3052
    Australia

    Active - Recruiting

  • Landeskrankenhaus Bregenz /ID# 266317

    Bregenz, Vorarlberg 6900
    Austria

    Active - Recruiting

  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769

    Juiz de Fora, Minas Gerais 36010-570
    Brazil

    Active - Recruiting

  • Hospital Sao Paulo /ID# 251765

    Sao Paulo, 04023-062
    Brazil

    Active - Recruiting

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764

    Sao Paulo, 05403-000
    Brazil

    Active - Recruiting

  • Children's Hospital Affiliated to Chongqing Medical University /ID# 251539

    Chongqing, Chongqing 400014
    China

    Active - Recruiting

  • The Children's Hospital of Chongqing Medical University /ID# 251539

    Chongqing, Chongqing 400065
    China

    Active - Recruiting

  • Children'S Hospital Of Soochow University /ID# 251755

    Suzhou, Jiangsu 215025
    China

    Active - Recruiting

  • Xi'an Children's Hospital /ID# 251693

    Xi'an, Shaanxi 710054
    China

    Active - Recruiting

  • Children's Hospital of Fudan University /ID# 251619

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • The Children's Hospital of Zhejiang University School of Medicine /ID# 251754

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • Universitaetsklinikum Freiburg /ID# 253288

    Freiburg, Baden-Wuerttemberg 79106
    Germany

    Active - Recruiting

  • Asklepios Klinik Sankt Augustin /ID# 251565

    Sankt Augustin, Nordrhein-Westfalen 53757
    Germany

    Active - Recruiting

  • St. Josef-Stift Sendenhorst /ID# 268680

    Sendenhorst, Nordrhein-Westfalen 48324
    Germany

    Active - Recruiting

  • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564

    Hamburg, 22081
    Germany

    Active - Recruiting

  • Semmelweis Egyetem /ID# 266750

    Budapest, 1094
    Hungary

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Meyer /ID# 251775

    Florence, Firenze 50139
    Italy

    Active - Recruiting

  • IRCCS Istituto Giannina Gaslini /ID# 251776

    Genoa, Genova 16147
    Italy

    Active - Recruiting

  • Istituto Giannina Gaslini /ID# 251776

    Genova, L Aquila 16147
    Italy

    Site Not Available

  • Hyogo Prefectural Kobe Children's Hospital /ID# 251649

    Kobe-shi, Hyogo 650-0047
    Japan

    Active - Recruiting

  • St. Marianna University Hospital /ID# 251623

    Kawasaki-shi, Kanagawa 216-8511
    Japan

    Active - Recruiting

  • Niigata University Medical & Dental Hospital /ID# 251538

    Niigata-shi, Niigata 951-8520
    Japan

    Active - Recruiting

  • Osaka Medical and Pharmaceutical University Hospital /ID# 252092

    Takatsuki-shi, Osaka 569-8686
    Japan

    Active - Recruiting

  • Institute of Science Tokyo Hospital /ID# 251505

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Tokyo Medical And Dental University Hospital /ID# 251505

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Active - Recruiting

  • CREA de Guadalajara SC /ID# 252917

    Guadalajara, Jalisco 44620
    Mexico

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht /ID# 267435

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

  • Hospital Sant Joan de Deu /ID# 251353

    Esplugues de Llobregat, Barcelona 08950
    Spain

    Active - Recruiting

  • Hospital Universitario y Politecnico La Fe /ID# 251352

    Valencia, 46026
    Spain

    Active - Recruiting

  • Queen Silvia Children's Hosp /ID# 251318

    Gothenburg, Vastra Gotalands Lan 416 85
    Sweden

    Active - Recruiting

  • National Taiwan University Hospital /ID# 267387

    Taipei City, Taipei 100
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital /ID# 267390

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

  • Gazi University Medical Faculty /ID# 253677

    Ankara, 06560
    Turkey

    Active - Recruiting

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 251651

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Istanbul University Istanbul Medical Faculty /ID# 251652

    Istanbul, 34093
    Turkey

    Active - Recruiting

  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 251651

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Umraniye Training and Res Hosp /ID# 251653

    Istanbul, 34764
    Turkey

    Active - Recruiting

  • Great Ormond Street Children's Hospital /ID# 251512

    London, Greater London WC1N 3HZ
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital For Children NHS Foundation Trust /ID# 251512

    London, WC1N 3JH
    United Kingdom

    Active - Recruiting

  • New York Medical College /ID# 253437

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • Levine Children's Hospital /ID# 253491

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Randall Children's Hospital /ID# 251829

    Portland, Oregon 97227-1654
    United States

    Active - Recruiting

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