Actively Recruiting
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 With Systemic Juvenile Idiopathic Arthritis
Led by Eli Lilly and Company · Updated on 2026-02-10
58
Participants Needed
55
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of the drug baricitinib in children aged 1 to less than 18 years who have systemic juvenile idiopathic arthritis (sJIA). This study is a Phase 3 trial that compares baricitinib with tocilizumab in one group and evaluates baricitinib alone in another group. The goal is to understand how these treatments work for young patients with active joint disease due to sJIA. Participants are divided into two groups: Cohort 1 includes children who have not previously received IL-6 inhibitor therapy and are randomly assigned to receive either oral baricitinib or subcutaneous tocilizumab. Cohort 2 includes children who receive oral baricitinib without comparison. Treatments are given over several weeks, with key assessments planned at Week 12 and Week 24 to evaluate response and disease activity. Throughout the study, children will be monitored to see how many achieve specific improvements in their arthritis symptoms, measured by adapted pediatric response criteria and disease activity scores. Researchers will also track pain changes and baricitinib levels in the blood. The study involves regular visits for these assessments and safety checks, with participation lasting through Week 24 or longer as planned.
CONDITIONS
Brief Title
A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a diagnosis of systemic juvenile idiopathic arthritis (sJIA) with onset before age 16, according to ILAR criteria
- Participants must have at least 2 active joints at screening and baseline
- Participants in Cohort 1 must be between 1 and less than 18 years old and not previously treated with IL-6 inhibitors; tocilizumab may be restricted for those under 2 years in some countries
- Participants in Cohort 2 must be between 1 and less than 18 years old
You will not qualify if you...
- Participants with polyarticular JIA, extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis are excluded
- Participants with persistent oligoarticular arthritis are excluded
- Participants with other autoimmune inflammatory conditions besides JIA are excluded
- Participants with active anterior uveitis or receiving treatment for it are excluded
- Participants with active fibromyalgia or other chronic pain conditions affecting disease assessment are excluded
- Participants with biologic features of Macrophage Activation Syndrome (MAS) in the past 12 weeks are excluded
- Participants with a current or recent (less than 4 weeks prior) serious infection are excluded
- Participants who test positive for hepatitis B are excluded
- Participants with active tuberculosis or untreated latent TB are excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive treatment with either Baricitinib orally or Tocilizumab subcutaneously to evaluate safety, efficacy, and pharmacokinetics.
Regular visits during treatment for assessments and medication administration
Trial Site Locations
Total: 55 locations
1
Instituto CAICI SRL
Rosario, Argentina, S2000
Actively Recruiting
2
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, Argentina, T4000AXL
Actively Recruiting
3
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
4
Faculdade de Medicina da UNESP
Botucatu, Brazil, 18618-686
Actively Recruiting
5
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Actively Recruiting
6
IPITEC
São Paulo, Brazil, 01221-020
Not Yet Recruiting
7
Universidade Federal de Sao Paulo
São Paulo, Brazil, 04024-001
Actively Recruiting
8
Instituto da Crianca do Hospital das Clinicas da FMUSP
São Paulo, Brazil, 05403-000
Actively Recruiting
9
Detska nemocnice FN Brno
Brno, Czechia, 613 00
Actively Recruiting
10
Vseobecna fakultni nemocnice v Praze
Prague, Czechia, 12808
Actively Recruiting
11
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, France, 69500
Actively Recruiting
12
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
13
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France, 30029
Actively Recruiting
14
Hôpital Universitaire Necker Enfants Malades
Paris, France, 75015
Actively Recruiting
15
Centre Hospitalier Universitaire de Poitiers
Poitiers, France, 86021
Actively Recruiting
16
Sir Ganga Ram Hospital
New Delhi, India, 110060
Actively Recruiting
17
Meir Medical Center
Kfar Saba, Israel, 4428164
Actively Recruiting
18
Schneider Children's Medical Center
Petah Tikva, Israel, 49202
Actively Recruiting
19
Sheba Medical Center
Ramat Gan, Israel, 5262100
Actively Recruiting
20
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
21
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
Chieti, Italy, 66100
Completed
22
IRCCS Istituto Giannina Gaslini
Genova, Italy, 16147
Actively Recruiting
23
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milan, Italy, 20122
Actively Recruiting
24
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Completed
25
University of Naples Federico II
Naples, Italy, 80131
Actively Recruiting
26
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, Italy, 90127
Actively Recruiting
27
Ospedale Infantile Burlo Garofolo
Trieste, Italy, 34137
Actively Recruiting
28
Institute of Science Tokyo Hospital
Bunkyō, Japan, 113-8510
Actively Recruiting
29
Chiba Children's Hospital
Chiba, Japan, 266-0007
Actively Recruiting
30
Kagoshima University Hospital
Kagoshima, Japan, 890-8520
Actively Recruiting
31
Miyagi Children's Hospital
Sendai, Japan, 989-3126
Actively Recruiting
32
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Japan, 569-8686
Actively Recruiting
33
Kanagawa Children's Medical Center
Yokohama, Japan, 232-8555
Actively Recruiting
34
Yokohama City University Hospital
Yokohama, Japan, 236-0004
Actively Recruiting
35
Investigacion y Biomedicina de Chihuahua
Chihuahua City, Mexico, 31000
Actively Recruiting
36
Instituto de Investigaciones Clínicas para la Salud
Durango, Mexico, 34000
Actively Recruiting
37
Crea de Guadalajara
Guadalajara, Mexico, 44600
Actively Recruiting
38
Clinstile, S.A. de C.V.
México, Mexico, 06700
Actively Recruiting
39
Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León
Monterrey, Mexico, 66460
Actively Recruiting
40
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, Poland, 31-503
Actively Recruiting
41
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, Poland, 91-738
Actively Recruiting
42
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, Poland, 02-637
Actively Recruiting
43
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain, 08950
Actively Recruiting
44
Hospital Infantil Universitario Niño Jesús
Madrid, Spain, 28009
Actively Recruiting
45
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
46
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
47
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
48
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
49
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
50
9 Eylul University Hospital
Izmir, Turkey (Türkiye), 35340
Actively Recruiting
51
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Actively Recruiting
52
Alder Hey Children's Hospital
Liverpool, United Kingdom, L12 2AB
Actively Recruiting
53
Great Ormond Street Hospital For Children NHS Foundation Trust
London, United Kingdom, WC1N 3JH
Completed
54
Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford, United Kingdom, OX3 7HE
Actively Recruiting
55
Sheffield Children's Hospital
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please 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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