Juvenile Idiopathic ArthritisPhase 3SELECT-sJIANCT05609630
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.
A Phase 3 study testing Upadacitinib and Tocilizumab in people with Juvenile Idiopathic Arthritis, run by AbbVie at 45 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Upadacitinib and Tocilizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 45 sitesin 17 countries
- Study dates
- 2 Oct 2023to Jun 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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, 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.
Who cannot join
- Has any type of juvenile idiopathic arthritis (JIA), other than sJIA, as defined by the ILAR criteria, and must not have a history or presence of any other autoimmune inflammatory condition other than sJIA.
- Has uncontrolled severe systemic disease and/or impeding or active macrophage activation syndrome within 1 month prior to Baseline.
Trial locations and contacts
45 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
45 sites in 17 countries
United States6 sites, 5 recruiting
- Completed
Levine Children's Hospital /ID# 253491
Charlotte, North Carolina, 28203
- Recruiting
Cincinnati Childrens Hospital Medical Center /ID# 251827
Cincinnati, Ohio, 45229
Site Coordinator, 1-513-636-3644, megan.quinlan-waters@cchmc.org
- Recruiting
Phoenix Children's Hospital /ID# 253403
Phoenix, Arizona, 85016-7710
Site Coordinator, 602-933-3822, sgorry@phoenixchildrens.com
- Recruiting
Randall Children's Hospital /ID# 251829
Portland, Oregon, 97227-1654
Site Coordinator, 1-503-413-3508, bbogle@lhs.org
- Recruiting
Boston Childrens Health Physicians /ID# 253437
Valhalla, New York, 10595
Site Coordinator, 914-504-0152
- Recruiting
Childrens National Medical Center /ID# 253344
Washington D.C., District of Columbia, 20010-2916
China5 sites, 5 recruiting
- Recruiting
The Childrens Hospital of Chongqing Medical University /ID# 251539
Chongqing, Chongqing Municipality, 400065
- Recruiting
The Children's Hospital of Zhejiang University School of Medicine /ID# 251754
Hangzhou, Zhejiang, 310003
- Recruiting
Children's Hospital of Fudan University /ID# 251619
Shanghai, Shanghai Municipality, 200032
- Recruiting
Children'S Hospital Of Soochow University /ID# 251755
Suzhou, Jiangsu, 215025
- Recruiting
Xi'an Children's Hospital /ID# 251693
Xi'an, Shaanxi, 710054
Germany5 sites, 5 recruiting
- Recruiting
Helios Klinikum Berlin - Buch /ID# 279847
Berlin, 13125
- Recruiting
Universitaetsklinikum Freiburg /ID# 253288
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Site Coordinator, kjk.pedrheum@uniklinik-freiburg.de
- Recruiting
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564
Hamburg, 22081
- Recruiting
Asklepios Klinik Sankt Augustin /ID# 251565
Sankt Augustin, North Rhine-Westphalia, 53757
- Recruiting
St. Josef-Stift Sendenhorst /ID# 268680
Sendenhorst, North Rhine-Westphalia, 48324
Japan5 sites, 5 recruiting
- Recruiting
Institute of Science Tokyo Hospital /ID# 251505
Bunkyo-ku, Tokyo, 113-8519
- Recruiting
St Marianna University School Of Medicine /ID# 251623
Kawasaki-shi, Kanagawa, 216-8511
- Recruiting
Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 251649
Kobe, Hyōgo, 650-0045
Site Coordinator, +81-78-945-7300
- Recruiting
Niigata University Medical and Dental Hospital /ID# 251538
Niigata, Niigata, 951-8520
- Recruiting
Osaka Medical and Pharmaceutical University Hospital /ID# 252092
Takatsuki-shi, Osaka, 569-8686
Turkey (Türkiye)4 sites, 3 recruiting
- Completed
Gazi University Medical Faculty /ID# 253677
Ankara, 06560
- Recruiting
Istanbul University Istanbul Medical Faculty /ID# 251652
Istanbul, 34093
- Recruiting
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 251651
Istanbul, 34098
- Recruiting
Umraniye Training and Res Hosp /ID# 251653
Istanbul, 34764
Argentina3 sites, 3 recruiting
- Recruiting
Hospital de Niños de la Santisima Trinidad /ID# 252736
Córdoba, 5014
Site Coordinator, 351 458-6405
- Recruiting
Instituto CAICI S.R.L /ID# 251448
Rosario, Santa Fe Province, 2000
- Recruiting
Centro de Investigaciones Medicas Tucuman /ID# 251781
San Miguel de Tucumán, Tucumán Province, 4000
Brazil3 sites, 2 recruiting
- Completed
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769
Juiz de Fora, Minas Gerais, 36010-570
- Recruiting
Hospital Sao Paulo /ID# 251765
São Paulo, 04023-062
- Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764
São Paulo, 05403-000
Australia2 sites
- Completed
Monash Health - Monash Medical Centre - Clayton /ID# 251691
Clayton, Victoria, 3168
- Completed
Royal Children's Hospital /ID# 251663
Parkville, Victoria, 3052
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Meyer /ID# 251775
Florence, Firenze, 50139
- Recruiting
IRCCS Istituto Giannina Gaslini /ID# 251776
Genoa, Genova, 16147
Spain2 sites, 2 recruiting
- Recruiting
Hospital Sant Joan de Deu /ID# 251353
Esplugues de Llobregat, Barcelona, 08950
- Recruiting
Hospital Universitario y Politecnico La Fe /ID# 251352
Valencia, 46026
Site Coordinator, +34 961 244 357, reumainf_lafe@gva.es
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital /ID# 267387
Taipei, 100
- Recruiting
Linkou Chang Gung Memorial Hospital /ID# 267390
Taoyuan City, 333
Austria1 site, 1 recruiting
- Recruiting
Landeskrankenhaus Bregenz /ID# 266317
Bregenz, Vorarlberg, 6900
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis Egyetem /ID# 266750
Budapest, 1085
Mexico1 site, 1 recruiting
- Recruiting
CREA de Guadalajara SC /ID# 252917
Guadalajara, Jalisco, 44620
Netherlands1 site, 1 recruiting
- Recruiting
Universitair Medisch Centrum Utrecht /ID# 267435
Utrecht, 3584 CX
Sweden1 site, 1 recruiting
- Recruiting
Queen Silvia Children's Hosp /ID# 251318
Gothenburg, Västra Götaland County, 416 85
Site Coordinator, +46313435865
United Kingdom1 site, 1 recruiting
- Recruiting
Great Ormond Street Children's Hospital /ID# 251512
London, Greater London, WC1N 3HZ
About this study
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
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.
Read more
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
- Juvenile Idiopathic Arthritis
- Being tested
- Upadacitinib, Tocilizumab
- Keywords
- Systemic Juvenile Idiopathic Arthritis, sJIA, Upadacitinib, ABT-494
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Also called RINVOQ, ABT-494
Oral tablet or Oral solution
TocilizumabDrug
Subcutaneous injection or Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Upadacitinib | Experimental | Participants will receive upadacitinib for 52 weeks. Receives: Drug: Upadacitinib |
| Cohort 1 Tocilizumab | Active comparator | Participants will receive tocilizumab for 52 weeks. Receives: Drug: Tocilizumab |
| Cohort 2 Upadacitinib | Experimental | Participants will receive upadacitinib for 52 weeks. Receives: Drug: Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response
ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 30 Response is defined as absence of fever [> 38°C] in the previous 1 week preceding evaluation and improvement of ≥ 30% of the 6 variables of the JIA core set with no more than 1 variable worsening by > 30%.
Measured: At Week 12
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately Week 52
Secondary outcomes (16)
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 50 Response
ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 50 Response is defined as absence of fever [> 38°C] in the previous 1 week preceding evaluation and improvement of ≥ 50% of the 6 variables of the JIA core set.
Measured: Week 12
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 70 Response
ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 70 Response is defined as absence of fever [> 38°C] in the previous 1 week preceding evaluation and improvement of ≥ 70% of the 6 variables of the JIA core set.
Measured: Week 12
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 90 Response
ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 90 Response is defined as absence of fever [> 38°C] in the previous 1 week preceding evaluation and improvement of ≥ 90% of the 6 variables of the JIA core set.
Measured: Week 12
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 100 Response
ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 100 Response is defined as absence of fever [> 38°C] in the previous 1 week preceding evaluation and improvement of ≥ 100% of the 6 variables of the JIA core set.
Measured: Week 12
Change from Baseline in Number of Joints with Active Arthritis
Change from Baseline in Number of Joints with Active Arthritis
Measured: Week 12
Change from Baseline in Number of Joints with Limitation of Motion
Change from Baseline in Number of Joints with Limitation of Motion
Measured: Week 12
Change from Baseline in Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI)
The CHAQ-DI consists of 30 items and assesses function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 5 response options ranging from no difficulty to unable to do, scored 0 to 3, and not applicable.
Measured: Week 12
Change From Baseline in Patient's Global Assessment (PtGA)
Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.
Measured: Week 12
Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)
Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.
Measured: Week 12
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
High sensitivity C-reactive protein was analyzed by a central laboratory. The median percent change from baseline in CRP is assessed at each time point.
Measured: Week 12
Percentage of Participants with Absence of fever (> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)
Absence of fever (> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)
Measured: Week 12
Change from Baseline in Glucocorticoid Dose
Change from Baseline in Glucocorticoid Dose
Measured: Week 12
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP)
Juvenile Arthritis Disease Activity Score (JADAS27-CRP) will be assessed
Measured: Week 12
Percentage of Participants Achieving Inactive Disease (ID) Status by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
Inactive Disease (ID) status by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.
Measured: Week 12
Percentage of Participants Achieving Minimal Disease Activity (MDA) by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
Minimal Disease Activity (MDA) by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.
Measured: Week 12
Percentage of Participants Achieving Clinical Remission by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
Clinical Remission by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start2 Oct 2023
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609630
- Sponsor's protocol ID
- M14-682
- Other IDs
- 2022-501599-25-00
- Acronym
- SELECT-sJIA
- Status last verified
- Sep 2026
- First submitted
- 7 Nov 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.