AzTrials
AzTrials

Systemic Juvenile Idiopathic ArthritisPhase 3NCT04088396

A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)

A Phase 3 study testing Baricitinib and Tocilizumab in people with Systemic Juvenile Idiopathic Arthritis, run by Eli Lilly and Company at 55 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 year to 17 years
Conditions the study is for
Systemic Juvenile Idiopathic Arthritis
What is being tested?
Baricitinib and Tocilizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
55 sitesin 14 countries
Study dates
12 Feb 2020to Oct 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

55 sites in 14 countries.

55 sites in 14 countries

Italy8 sites

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123

  • Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

    Chieti, 66100

  • IRCCS Istituto Giannina Gaslini

    Genova, 16147

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

    Milan, 20122

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • University of Naples Federico II

    Naples, 80131

  • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

    Palermo, 90127

  • Ospedale Infantile Burlo Garofolo

    Trieste, 34137

Other trials in Italy

Japan7 sites

  • Institute of Science Tokyo Hospital

    Bunkyō, 113-8510

  • Chiba Children's Hospital

    Chiba, 266-0007

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Miyagi Children's Hospital

    Sendai, 989-3126

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686

  • Kanagawa Children's Medical Center

    Yokohama, 232-8555

  • Yokohama City University Hospital

    Yokohama, 236-0004

Other trials in Japan

Spain6 sites

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, 08950

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Brazil5 sites

  • Faculdade de Medicina da UNESP

    Botucatu, 18618-686

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • IPITEC

    São Paulo, 01221-020

  • Universidade Federal de Sao Paulo

    São Paulo, 04024-001

  • Instituto da Crianca do Hospital das Clinicas da FMUSP

    São Paulo, 05403-000

Other trials in Brazil

France5 sites

  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant

    Bron, 69500

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270

  • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

  • Hôpital Universitaire Necker Enfants Malades

    Paris, 75015

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

Other trials in France

Mexico5 sites

  • Investigacion y Biomedicina de Chihuahua

    Chihuahua City, 31000

  • Instituto de Investigaciones Clínicas para la Salud

    Durango, 34000

  • Crea de Guadalajara

    Guadalajara, 44600

  • Clinstile, S.A. de C.V.

    México, 06700

  • Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León

    Monterrey, 66460

Other trials in Mexico

United Kingdom5 sites

  • Bristol Royal Hospital for Children

    Bristol, BS2 8BJ

  • Alder Hey Children's Hospital

    Liverpool, L12 2AB

  • Great Ormond Street Hospital For Children NHS Foundation Trust

    London, WC1N 3JH

  • Oxford University Hospitals - Nuffield Orthopaedic Centre

    Oxford, OX3 7HE

  • Sheffield Children's Hospital

    Sheffield, S10 2TH

Other trials in United Kingdom

Israel3 sites

  • Meir Medical Center

    Kfar Saba, 4428164

  • Schneider Children's Medical Center

    Petah Tikva, 49202

  • Sheba Medical Center

    Ramat Gan, 5262100

Other trials in Israel

Poland3 sites

  • Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

    Krakow, 31-503

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    Lodz, 91-738

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    Warsaw, 02-637

Other trials in Poland

Argentina2 sites

  • Instituto CAICI SRL

    Rosario, S2000

  • Centro Medico Privado de Reumatologia

    SAN M. de Tucuman, T4000AXL

Other trials in Argentina

Czechia2 sites

  • Detska nemocnice FN Brno

    Brno, 613 00

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

Other trials in Czechia

Turkey (Türkiye)2 sites

  • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

    Istanbul, 34098

  • 9 Eylul University Hospital

    Izmir, 35340

Other trials in Turkey (Türkiye)

Belgium1 site

  • UZ Gent

    Ghent, 9000

Other trials in Belgium

India1 site

  • Sir Ganga Ram Hospital

    New Delhi, 110060

Other trials in India

About this study

Official title: 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.

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.

Being tested
Baricitinib, Tocilizumab
Keywords
Systemic, Fever, Flare, sJIA, JIA
Medical subject headings
Arthritis, Juvenile, Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaricitinibDrug

    Also called LY3009104

    Administered orally

  • TocilizumabDrug

    Administered SC

Study groups in NCT04088396
Study groupRoleWhat they receive
Cohort 1 BaricitinibExperimentalBaricitinib given orally.
Receives: Drug: Baricitinib
Cohort 1 TocilizumabActive comparatorTocilizumab given Subcutaneously (SC).
Receives: Drug: Tocilizumab
Cohort 2 BaricitinibExperimentalBaricitinib given orally.
Receives: Drug: Baricitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 12

Secondary outcomes (7)

  1. Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24

    Percentage of Participants Achieving Adapted PediACR30 Response Criteria

    Measured: Week 24

  2. Percentage of Participants with Inactive Disease

    Percentage of Participants with Inactive Disease

    Measured: Week 12

  3. Percentage of Participants with Minimal Disease Activity

    Percentage of Participants with Minimal Disease Activity

    Measured: Week 12

  4. Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27

    Change from Baseline in JADAS-27

    Measured: Baseline, Week 24

  5. Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item

    Change from Baseline in Arthritis-Related Pain Severity as Measured by the CHAQ Pain VAS Item

    Measured: Baseline, Week 24

  6. Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)

    PK: Cmax, ss of Baricitinib

    Measured: Baseline through Week 24

  7. PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss)

    PK: AUC, ss of Baricitinib

    Measured: Baseline through Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2019
  2. Study start12 Feb 2020
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

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
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04088396
Sponsor's protocol ID
16275
Other IDs
I4V-MC-JAHU, 2017-004495-60, 2023-507883-38-00, 2023, 2017
Status last verified
Aug 2026
First submitted
11 Sep 2019
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baricitinib and Tocilizumab in people with Systemic Juvenile Idiopathic Arthritis, run by Eli Lilly and Company at 55 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Italy, Japan, Spain, Brazil, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04088396.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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