Actively Recruiting
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.
Led by AbbVie · Updated on 2026-02-10
90
Participants Needed
44
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child weighs 10 kg or more at screening
- Diagnosed with systemic juvenile idiopathic arthritis (sJIA) according to ILAR criteria for at least 6 weeks before screening with disease onset before age 16
- Has active sJIA with either at least 2 active joints plus fever above 38°C within 14 days before screening and elevated ESR or hsCRP, or at least 4 active joints with elevated ESR or hsCRP at screening
- Has not responded adequately to nonsteroidal anti-inflammatory drugs or systemic glucocorticoids
- For Cohort 1, no prior treatment with IL-6 inhibitors; for Cohort 2, has intolerance or inadequate response to IL-6 inhibitors
- For Cohort 1 in countries where subcutaneous tocilizumab is not approved for sJIA, participants must be aged 2 to under 18 years
You will not qualify if you...
- Has any type of juvenile idiopathic arthritis other than systemic JIA
- Has a history or current presence of any other autoimmune inflammatory condition besides systemic JIA
- Has uncontrolled severe systemic disease
- Has impeding or active macrophage activation syndrome within 1 month before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 44 locations
1
Phoenix Children's Hospital /ID# 253403
Phoenix, Arizona, United States, 85016-7710
Actively Recruiting
2
Childrens National Medical Center /ID# 253344
Washington D.C., District of Columbia, United States, 20010-2916
Actively Recruiting
3
New York Medical College /ID# 253437
Valhalla, New York, United States, 10595
Actively Recruiting
4
Levine Children's Hospital /ID# 253491
Charlotte, North Carolina, United States, 28203
Actively Recruiting
5
Cincinnati Childrens Hospital Medical Center /ID# 251827
Cincinnati, Ohio, United States, 45229
Actively Recruiting
6
Randall Children's Hospital /ID# 251829
Portland, Oregon, United States, 97227-1654
Actively Recruiting
7
Instituto CAICI S.R.L /ID# 251448
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
8
Centro de Investigaciones Medicas Tucuman /ID# 251781
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
9
Hospital de Niños de la Santisima Trinidad /ID# 252736
Córdoba, Argentina, 5014
Actively Recruiting
10
Monash Health - Monash Medical Centre /ID# 251691
Clayton, Victoria, Australia, 3168
Completed
11
Royal Children's Hospital /ID# 251663
Parkville, Victoria, Australia, 3052
Completed
12
Landeskrankenhaus Bregenz /ID# 266317
Bregenz, Vorarlberg, Austria, 6900
Actively Recruiting
13
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Completed
14
Hospital Sao Paulo /ID# 251765
São Paulo, Brazil, 04023-062
Actively Recruiting
15
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764
São Paulo, Brazil, 05403-000
Actively Recruiting
16
The Childrens Hospital of Chongqing Medical University /ID# 251539
Chongqing, Chongqing Municipality, China, 400065
Actively Recruiting
17
Children'S Hospital Of Soochow University /ID# 251755
Suzhou, Jiangsu, China, 215025
Actively Recruiting
18
Xi'an Children's Hospital /ID# 251693
Xi'an, Shaanxi, China, 710054
Actively Recruiting
19
Children's Hospital of Fudan University /ID# 251619
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
20
The Children's Hospital of Zhejiang University School of Medicine /ID# 251754
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
21
Universitaetsklinikum Freiburg /ID# 253288
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
22
Asklepios Klinik Sankt Augustin /ID# 251565
Sankt Augustin, North Rhine-Westphalia, Germany, 53757
Actively Recruiting
23
St. Josef-Stift Sendenhorst /ID# 268680
Sendenhorst, North Rhine-Westphalia, Germany, 48324
Actively Recruiting
24
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564
Hamburg, Germany, 22081
Actively Recruiting
25
Semmelweis Egyetem /ID# 266750
Budapest, Hungary, 1085
Actively Recruiting
26
Azienda Ospedaliero Universitaria Meyer /ID# 251775
Florence, Firenze, Italy, 50139
Actively Recruiting
27
IRCCS Istituto Giannina Gaslini /ID# 251776
Genoa, Genova, Italy, 16147
Actively Recruiting
28
Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 251649
Kobe, Hyōgo, Japan, 650-0045
Actively Recruiting
29
St Marianna University School Of Medicine /ID# 251623
Kawasaki-shi, Kanagawa, Japan, 216-8511
Actively Recruiting
30
Niigata University Medical & Dental Hospital /ID# 251538
Niigata, Niigata, Japan, 951-8520
Actively Recruiting
31
Osaka Medical and Pharmaceutical University Hospital /ID# 252092
Takatsuki-shi, Osaka, Japan, 569-8686
Actively Recruiting
32
Institute of Science Tokyo Hospital /ID# 251505
Bunkyo-ku, Tokyo, Japan, 113-8519
Actively Recruiting
33
CREA de Guadalajara SC /ID# 252917
Guadalajara, Jalisco, Mexico, 44620
Actively Recruiting
34
Universitair Medisch Centrum Utrecht /ID# 267435
Utrecht, Netherlands, 3584 CX
Actively Recruiting
35
Hospital Sant Joan de Deu /ID# 251353
Esplugues de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
36
Hospital Universitario y Politecnico La Fe /ID# 251352
Valencia, Spain, 46026
Actively Recruiting
37
Queen Silvia Children's Hosp /ID# 251318
Gothenburg, Västra Götaland County, Sweden, 416 85
Actively Recruiting
38
National Taiwan University Hospital /ID# 267387
Taipei, Taiwan, 100
Actively Recruiting
39
Linkou Chang Gung Memorial Hospital /ID# 267390
Taoyuan City, Taiwan, 333
Actively Recruiting
40
Gazi University Medical Faculty /ID# 253677
Ankara, Turkey (Türkiye), 06560
Actively Recruiting
41
Istanbul University Istanbul Medical Faculty /ID# 251652
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
42
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 251651
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
43
Umraniye Training and Res Hosp /ID# 251653
Istanbul, Turkey (Türkiye), 34764
Actively Recruiting
44
Great Ormond Street Children's Hospital /ID# 251512
London, Greater London, United Kingdom, WC1N 3HZ
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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