A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.
4 other identifiers
interventional
58
14 countries
55
Brief Summary
The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2020
Longer than P75 for phase_3
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedStudy Start
First participant enrolled
February 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
February 10, 2026
February 1, 2026
6.6 years
September 11, 2019
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12
Percentage of Participants Achieving Adapted PediACR30 Response Criteria
Week 12
Secondary Outcomes (7)
Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24
Week 24
Percentage of Participants with Inactive Disease
Week 12
Percentage of Participants with Minimal Disease Activity
Week 12
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27
Baseline, Week 24
Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item
Baseline, Week 24
- +2 more secondary outcomes
Study Arms (3)
Cohort 1 Baricitinib
EXPERIMENTALBaricitinib given orally.
Cohort 1 Tocilizumab
ACTIVE COMPARATORTocilizumab given Subcutaneously (SC).
Cohort 2 Baricitinib
EXPERIMENTALBaricitinib given orally.
Interventions
Eligibility Criteria
You may qualify if:
- Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years
- Participants must have at least 2 active joints at screening and baseline
- Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age
- Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age
You may not qualify if:
- Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis
- Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria
- Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA
- Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis
- Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study
- Participants must not have biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks
- Participants must not have a current or recent (\<4 weeks prior to baseline) clinically serious infection
- Participants must not have a positive test for hepatitis B virus
- Participants must not have evidence of active tuberculosis (TB) or untreated latent TB
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Instituto CAICI SRL
Rosario, S2000, Argentina
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, T4000AXL, Argentina
UZ Gent
Ghent, 9000, Belgium
Faculdade de Medicina da UNESP
Botucatu, 18618-686, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
IPITEC
São Paulo, 01221-020, Brazil
Universidade Federal de Sao Paulo
São Paulo, 04024-001, Brazil
Instituto da Crianca do Hospital das Clinicas da FMUSP
São Paulo, 05403-000, Brazil
Detska nemocnice FN Brno
Brno, 613 00, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 12808, Czechia
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, 69500, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270, France
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
Hôpital Universitaire Necker Enfants Malades
Paris, 75015, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Sir Ganga Ram Hospital
New Delhi, 110060, India
Meir Medical Center
Kfar Saba, 4428164, Israel
Schneider Children's Medical Center
Petah Tikva, 49202, Israel
Sheba Medical Center
Ramat Gan, 5262100, Israel
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123, Italy
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
Chieti, 66100, Italy
IRCCS Istituto Giannina Gaslini
Genova, 16147, Italy
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milan, 20122, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
University of Naples Federico II
Naples, 80131, Italy
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, 90127, Italy
Ospedale Infantile Burlo Garofolo
Trieste, 34137, Italy
Institute of Science Tokyo Hospital
Bunkyō, 113-8510, Japan
Chiba Children's Hospital
Chiba, 266-0007, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Miyagi Children's Hospital
Sendai, 989-3126, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, 569-8686, Japan
Kanagawa Children's Medical Center
Yokohama, 232-8555, Japan
Yokohama City University Hospital
Yokohama, 236-0004, Japan
Investigacion y Biomedicina de Chihuahua
Chihuahua City, 31000, Mexico
Instituto de Investigaciones Clínicas para la Salud
Durango, 34000, Mexico
Crea de Guadalajara
Guadalajara, 44600, Mexico
Clinstile, S.A. de C.V.
México, 06700, Mexico
Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León
Monterrey, 66460, Mexico
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, 31-503, Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, 91-738, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, 02-637, Poland
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, 28009, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, 34098, Turkey (Türkiye)
9 Eylul University Hospital
Izmir, 35340, Turkey (Türkiye)
Bristol Royal Hospital for Children
Bristol, BS2 8BJ, United Kingdom
Alder Hey Children's Hospital
Liverpool, L12 2AB, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
London, WC1N 3JH, United Kingdom
Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford, OX3 7HE, United Kingdom
Sheffield Children's Hospital
Sheffield, S10 2TH, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2019
First Posted
September 12, 2019
Study Start
February 12, 2020
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.