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

NCT ID: NCT04088396

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-12

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Juvenile Idiopathic Arthritis

Keywords

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Systemic Fever Flare sJIA JIA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1 Baricitinib

Baricitinib given orally.

Group Type EXPERIMENTAL

Baricitinib

Intervention Type DRUG

Administered orally

Cohort 1 Tocilizumab

Tocilizumab given Subcutaneously (SC).

Group Type ACTIVE_COMPARATOR

Tocilizumab

Intervention Type DRUG

Administered SC

Cohort 2 Baricitinib

Baricitinib given orally.

Group Type EXPERIMENTAL

Baricitinib

Intervention Type DRUG

Administered orally

Interventions

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Baricitinib

Administered orally

Intervention Type DRUG

Tocilizumab

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3009104

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Instituto CAICI SRL

Rosario, , Argentina

Site Status RECRUITING

Centro Medico Privado de Reumatologia

SAN M. de Tucuman, , Argentina

Site Status RECRUITING

UZ Gent

Ghent, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Faculdade de Medicina da UNESP

Botucatu, , Brazil

Site Status RECRUITING

Hospital de Clinicas de Porto Alegre

Porto Alegre, , Brazil

Site Status RECRUITING

IPITEC

São Paulo, , Brazil

Site Status NOT_YET_RECRUITING

Universidade Federal de Sao Paulo

São Paulo, , Brazil

Site Status RECRUITING

Instituto da Crianca do Hospital das Clinicas da FMUSP

São Paulo, , Brazil

Site Status RECRUITING

Detska nemocnice FN Brno

Brno, , Czechia

Site Status RECRUITING

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Site Status RECRUITING

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

Site Status RECRUITING

Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Bron, , France

Site Status RECRUITING

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status RECRUITING

Hôpital Universitaire Necker Enfants Malades

Paris, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Poitiers

Poitiers, , France

Site Status RECRUITING

Sir Ganga Ram Hospital

New Delhi, , India

Site Status RECRUITING

Meir Medical Center

Kfar Saba, , Israel

Site Status RECRUITING

Schneider Children's Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, , Italy

Site Status RECRUITING

Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

Chieti, , Italy

Site Status COMPLETED

IRCCS Istituto Giannina Gaslini

Genova, , Italy

Site Status RECRUITING

Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

Milan, , Italy

Site Status RECRUITING

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status COMPLETED

University of Naples Federico II

Napoli, , Italy

Site Status RECRUITING

Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

Palermo, , Italy

Site Status RECRUITING

Ospedale Infantile Burlo Garofolo

Trieste, , Italy

Site Status RECRUITING

Institute of Science Tokyo Hospital

Bunkyō, , Japan

Site Status RECRUITING

Chiba Children's Hospital

Chiba, , Japan

Site Status RECRUITING

Kagoshima University Hospital

Kagoshima, , Japan

Site Status RECRUITING

Miyagi Children's Hospital

Sendai, , Japan

Site Status RECRUITING

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, , Japan

Site Status RECRUITING

Kanagawa Children's Medical Center

Yokohama, , Japan

Site Status RECRUITING

Yokohama City University Hospital

Yokohama, , Japan

Site Status RECRUITING

Investigacion y Biomedicina de Chihuahua

Chihuahua City, , Mexico

Site Status RECRUITING

Instituto de Investigaciones Clínicas para la Salud

Durango, , Mexico

Site Status RECRUITING

Crea de Guadalajara

Guadalajara, , Mexico

Site Status RECRUITING

Clinstile, S.A. de C.V.

México, , Mexico

Site Status RECRUITING

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

Monterrey, , Mexico

Site Status RECRUITING

Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

Krakow, , Poland

Site Status RECRUITING

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, , Poland

Site Status RECRUITING

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

Warsaw, , Poland

Site Status RECRUITING

Hospital Sant Joan de Déu

Esplugues de Llobregat, , Spain

Site Status RECRUITING

Hospital Infantil Universitario Niño Jesús

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Site Status RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status RECRUITING

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

9 Eylul University Hospital

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Bristol Royal Hospital for Children

Bristol, , United Kingdom

Site Status RECRUITING

Alder Hey Children's Hospital

Liverpool, , United Kingdom

Site Status RECRUITING

Great Ormond Street Hospital For Children NHS Foundation Trust

London, , United Kingdom

Site Status COMPLETED

Oxford University Hospitals - Nuffield Orthopaedic Centre

Oxford, , United Kingdom

Site Status RECRUITING

Sheffield Children's Hospital

Sheffield, , United Kingdom

Site Status RECRUITING

Countries

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Austria Denmark Germany Russia Argentina Belgium Brazil Czechia France India Israel Italy Japan Mexico Poland Spain Turkey (Türkiye) United Kingdom

Central Contacts

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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Facility Contacts

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Role: primary

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Related Links

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https://trials.lillytrialguide.com/en-US/trial/4qr6645c2hmeJZWASkU2jH

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

Other Identifiers

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I4V-MC-JAHU

Identifier Type: OTHER

Identifier Source: secondary_id

2017-004495-60

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-507883-38-00

Identifier Type: CTIS

Identifier Source: secondary_id

16275

Identifier Type: -

Identifier Source: org_study_id