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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.
Sponsor: AbbVie
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.
Official title: 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
Key Details
Gender
All
Age Range
1 Year - 17 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2023-10-02
Completion Date
2029-06
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
Upadacitinib
Oral tablet or Oral solution
Tocilizumab
Subcutaneous injection or Intravenous infusion
Locations (44)
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, 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