Phase
Condition
Musculoskeletal Diseases
Connective Tissue Diseases
Joint Injuries
Treatment
Tocilizumab
Upadacitinib
Clinical Study ID
Ages 1-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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, 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
Connect with a study center
Instituto CAICI S.R.L /ID# 251448
Rosario, Santa Fe 2000
ArgentinaSite Not Available
Instituto CAICI S.R.L /ID# 251448
Rosario 3838583, Santa Fe Province 3836276 2000
ArgentinaActive - Recruiting
Centro de Investigaciones Medicas Tucuman /ID# 251781
San Miguel de Tucuman, Tucuman 4000
ArgentinaSite Not Available
Centro de Investigaciones Medicas Tucuman /ID# 251781
San Miguel de Tucumán 3836873, Tucumán Province 3833578 4000
ArgentinaActive - Recruiting
Hospital de Niños de la Santisima Trinidad /ID# 252736
Córdoba 3860259, 5014
ArgentinaActive - Recruiting
Monash Children's Clinical Trials Centre /ID# 251691
Clayton, Victoria 3168
AustraliaActive - Recruiting
Monash Children's Hospital /ID# 251691
Clayton, Victoria 3168
AustraliaActive - Recruiting
Monash Health - Monash Medical Centre /ID# 251691
Clayton, Victoria 3168
AustraliaSite Not Available
Monash Medical Centre /ID# 251691
Clayton, Victoria 3168
AustraliaActive - Recruiting
Royal Children's Hospital /ID# 251663
Parkville, Victoria 3052
AustraliaSite Not Available
Monash Health - Monash Medical Centre /ID# 251691
Clayton 2171400, Victoria 2145234 3168
AustraliaCompleted
Royal Children's Hospital /ID# 251663
Parkville 2153770, Victoria 2145234 3052
AustraliaCompleted
Landeskrankenhaus Bregenz /ID# 266317
Bregenz, Vorarlberg 6900
AustriaSite Not Available
Landeskrankenhaus Bregenz /ID# 266317
Bregenz 2781503, Vorarlberg 2762300 6900
AustriaActive - Recruiting
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769
Juiz de Fora, Minas Gerais 36010-570
BrazilSite Not Available
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769
Juiz de Fora 3459505, Minas Gerais 3457153 36010-570
BrazilCompleted
Hospital Sao Paulo /ID# 251765
Sao Paulo, Tocantins 04023-062
BrazilSite Not Available
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764
Sao Paulo, 05403-000
BrazilActive - Recruiting
Hospital Sao Paulo /ID# 251765
São Paulo 3448439, 04023-062
BrazilActive - Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764
São Paulo 3448439, 05403-000
BrazilActive - Recruiting
Children's Hospital Affiliated to Chongqing Medical University /ID# 251539
Chongqing, Chongqing 400014
ChinaActive - Recruiting
The Children's Hospital of Chongqing Medical University /ID# 251539
Chongqing, Chongqing 400065
ChinaSite Not Available
The Childrens Hospital of Chongqing Medical University /ID# 251539
Chongqing 1814906, Chongqing Municipality 1814905 400065
ChinaActive - Recruiting
Children's Hospital of Soochow University /ID# 251755
Suzhou, Jiangsu 215025
ChinaSite Not Available
Children'S Hospital Of Soochow University /ID# 251755
Suzhou 1886760, Jiangsu 1806260 215025
ChinaActive - Recruiting
Xi'an Children's Hospital /ID# 251693
Xi'an, Shaanxi 710054
ChinaSite Not Available
Xi'an Children's Hospital /ID# 251693
Xi'an 1790630, Shaanxi 1796480 710054
ChinaActive - Recruiting
Children's Hospital of Fudan University /ID# 251619
Shanghai, Shanghai 200032
ChinaSite Not Available
Children's Hospital of Fudan University /ID# 251619
Shanghai 1796236, Shanghai Municipality 1796231 200032
ChinaActive - Recruiting
The Children's Hospital of Zhejiang University School of Medicine /ID# 251754
Hangzhou, Zhejiang 310003
ChinaSite Not Available
The Children's Hospital of Zhejiang University School of Medicine /ID# 251754
Hangzhou 1808926, Zhejiang 1784764 310003
ChinaActive - Recruiting
Universitaetsklinikum Freiburg /ID# 253288
Freiburg, Baden-Wuerttemberg 79106
GermanySite Not Available
Universitaetsklinikum Freiburg /ID# 253288
Freiburg im Breisgau 2925177, Baden-Wurttemberg 2953481 79106
GermanyActive - Recruiting
Asklepios Klinik Sankt Augustin /ID# 251565
Sankt Augustin, Nordrhein-Westfalen 53757
GermanySite Not Available
St. Josef-Stift Sendenhorst /ID# 268680
Sendenhorst, Nordrhein-Westfalen 48324
GermanySite Not Available
Asklepios Klinik Sankt Augustin /ID# 251565
Sankt Augustin 2841648, North Rhine-Westphalia 2861876 53757
GermanyActive - Recruiting
St. Josef-Stift Sendenhorst /ID# 268680
Sendenhorst 2833076, North Rhine-Westphalia 2861876 48324
GermanyActive - Recruiting
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564
Hamburg, 22081
GermanySite Not Available
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564
Hamburg 2911298, 22081
GermanyActive - Recruiting
Semmelweis Egyetem /ID# 266750
Budapest, 1085
HungarySite Not Available
Semmelweis Egyetem /ID# 266750
Budapest 3054643, 1085
HungaryActive - Recruiting
Azienda Ospedaliero Universitaria Meyer /ID# 251775
Florence, Firenze 50139
ItalySite Not Available
Azienda Ospedaliero Universitaria Meyer /ID# 251775
Florence 3176959, Firenze 50139
ItalyActive - Recruiting
IRCCS Istituto Giannina Gaslini /ID# 251776
Genoa, Genova 16147
ItalySite Not Available
IRCCS Istituto Giannina Gaslini /ID# 251776
Genoa 3176219, Genova 16147
ItalyActive - Recruiting
Istituto Giannina Gaslini /ID# 251776
Genova, L Aquila 16147
ItalySite Not Available
Hyogo Prefectural Kobe Children's Hospital /ID# 251649
Kobe-shi, Hyogo 650-0047
JapanSite Not Available
Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 251649
Kobe 1859171, Hyōgo 1862047 650-0045
JapanActive - Recruiting
Hyogo Prefectural Kobe Children's Hospital /ID# 251649
Kobe 1859171, Hyōgo 1862047 650-0047
JapanActive - Recruiting
St. Marianna University Hospital /ID# 251623
Kawasaki-shi, Kanagawa 216-8511
JapanActive - Recruiting
St Marianna University School Of Medicine /ID# 251623
Kawasaki-shi, Kanagawa 1860291 216-8511
JapanActive - Recruiting
Niigata University Medical & Dental Hospital /ID# 251538
Niigata-shi, Niigata 951-8520
JapanSite Not Available
Niigata University Medical & Dental Hospital /ID# 251538
Niigata 1855431, Niigata 1855429 951-8520
JapanActive - Recruiting
Osaka Medical and Pharmaceutical University Hospital /ID# 252092
Takatsuki-shi, Osaka 1853904 569-8686
JapanActive - Recruiting
Tokyo Medical And Dental University Hospital /ID# 251505
Bunkyo-ku, Tokyo 113-8519
JapanActive - Recruiting
Institute of Science Tokyo Hospital /ID# 251505
Bunkyo-ku, Tokyo 1850144 113-8519
JapanActive - Recruiting
CREA de Guadalajara SC /ID# 252917
Guadalajara, Jalisco 44620
MexicoSite Not Available
CREA de Guadalajara SC /ID# 252917
Guadalajara 4005539, Jalisco 4004156 44620
MexicoActive - Recruiting
Universitair Medisch Centrum Utrecht /ID# 267435
Utrecht, 3584 CX
NetherlandsSite Not Available
Universitair Medisch Centrum Utrecht /ID# 267435
Utrecht 2745912, 3584 CX
NetherlandsActive - Recruiting
Hospital Sant Joan de Deu /ID# 251353
Esplugues de Llobregat, Barcelona 08950
SpainSite Not Available
Hospital Sant Joan de Deu /ID# 251353
Esplugues de Llobregat 3122826, Barcelona 08950
SpainActive - Recruiting
Hospital Universitario y Politecnico La Fe /ID# 251352
Valencia, 46026
SpainSite Not Available
Hospital Universitario y Politecnico La Fe /ID# 251352
Valencia 2509954, 46026
SpainActive - Recruiting
Queen Silvia Children's Hosp /ID# 251318
Gothenburg, Vastra Gotalands Lan 416 85
SwedenSite Not Available
Queen Silvia Children's Hosp /ID# 251318
Gothenburg 2711537, Västra Götaland County 3337386 416 85
SwedenActive - Recruiting
National Taiwan University Hospital /ID# 267387
Taipei City, Taipei 7280290 100
TaiwanSite Not Available
National Taiwan University Hospital /ID# 267387
Taipei 1668341, 100
TaiwanActive - Recruiting
Linkou Chang Gung Memorial Hospital /ID# 267390
Taoyuan 6696918, 333
TaiwanActive - Recruiting
Linkou Chang Gung Memorial Hospital /ID# 267390
Taoyuan City, 333
TaiwanSite Not Available
Gazi University Medical Faculty /ID# 253677
Ankara, 06560
TurkeySite Not Available
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 251651
Istanbul, 34098
TurkeyActive - Recruiting
Istanbul University Istanbul Medical Faculty /ID# 251652
Istanbul, 34093
TurkeyActive - Recruiting
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 251651
Istanbul, 34098
TurkeyActive - Recruiting
Umraniye Training and Res Hosp /ID# 251653
Istanbul, 34764
TurkeySite Not Available
Gazi University Medical Faculty /ID# 253677
Ankara 323786, 06560
Turkey (Türkiye)Active - Recruiting
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 251651
Istanbul 745044, 34098
Turkey (Türkiye)Active - Recruiting
Istanbul University Istanbul Medical Faculty /ID# 251652
Istanbul 745044, 34093
Turkey (Türkiye)Active - Recruiting
Umraniye Training and Res Hosp /ID# 251653
Istanbul 745044, 34764
Turkey (Türkiye)Active - Recruiting
Great Ormond Street Children's Hospital /ID# 251512
London, Greater London WC1N 3HZ
United KingdomSite Not Available
Great Ormond Street Children's Hospital /ID# 251512
London 2643743, Greater London WC1N 3HZ
United KingdomActive - Recruiting
Great Ormond Street Hospital For Children NHS Foundation Trust /ID# 251512
London, WC1N 3JH
United KingdomActive - Recruiting
Phoenix Children's Hospital /ID# 253403
Phoenix, Arizona 85016-7710
United StatesSite Not Available
Phoenix Children's Hospital /ID# 253403
Phoenix 5308655, Arizona 5551752 85016-7710
United StatesActive - Recruiting
Childrens National Medical Center /ID# 253344
Washington D.C. 4140963, District of Columbia 4138106 20010-2916
United StatesActive - Recruiting
New York Medical College /ID# 253437
Valhalla, New York 10595
United StatesSite Not Available
New York Medical College /ID# 253437
Valhalla 5142090, New York 5128638 10595
United StatesActive - Recruiting
Levine Children's Hospital /ID# 253491
Charlotte, North Carolina 28203
United StatesSite Not Available
Levine Children's Hospital /ID# 253491
Charlotte 4460243, North Carolina 4482348 28203
United StatesActive - Recruiting
Cincinnati Childrens Hospital Medical Center /ID# 251827
Cincinnati, Ohio 45229
United StatesSite Not Available
Cincinnati Childrens Hospital Medical Center /ID# 251827
Cincinnati 4508722, Ohio 5165418 45229
United StatesActive - Recruiting
Randall Children's Hospital /ID# 251829
Portland, Oregon 97227-1654
United StatesSite Not Available
Randall Children's Hospital /ID# 251829
Portland 5746545, Oregon 5744337 97227-1654
United StatesActive - Recruiting

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