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

February 29, 2024 updated by: Eli Lilly and Company

Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 1 Year to Less Than 18 Years Old 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

103

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: clinicaltrials.gov@lilly.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1270
        • Recruiting
        • Hospital General de Niños Dr. Pedro de Elizalde
        • Principal Investigator:
          • Ruben José Cuttica
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000
        • Recruiting
        • Instituto CAICI SRL
        • Principal Investigator:
          • Diego Oscar Viola
    • Tucumán
      • SAN M. DE Tucuman, Tucumán, Argentina, T4000AXL
        • Recruiting
        • Centro Medico Privado de Reumatologia
        • Principal Investigator:
          • Alberto Jorge Spindler
  • Austria
    • Wien
      • Vienna, Wien, Austria, 1090
        • Recruiting
        • Medizinische Universität Wien
        • Principal Investigator:
          • Wolfgang Emminger
  • Belgium
    • Bruxelles-Capitale, Région De
      • Brussels, Bruxelles-Capitale, Région De, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Principal Investigator:
          • Cecile Boulanger
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Principal Investigator:
          • Joke Dehoorne
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Principal Investigator:
          • Lien De Somer
  • Brazil
      • Rio de Janeiro, Brazil, 21941-612
        • Recruiting
        • IPPMG - Biblioteca Asdrubal Costa
        • Principal Investigator:
          • FLAVIO SZTAJNBOK
      • São Paulo, Brazil, 04022-001
        • Recruiting
        • Universidade Federal de São Paulo
        • Principal Investigator:
          • Maria Teresa Terreri
      • São Paulo, Brazil, 01223-001
        • Recruiting
        • IPITEC
        • Principal Investigator:
          • Maria Carolina dos Santos
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Principal Investigator:
          • Claiton Brenol
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-686
        • Recruiting
        • Faculdade de Medicina da UNESP
        • Principal Investigator:
          • Claudia Magalhaes
      • Sao Paulo, São Paulo, Brazil, 05403-000
        • Recruiting
        • Instituto da Crianca do Hospital das Clinicas da FMUSP
        • Principal Investigator:
          • Clovis Silva
  • Czechia
      • Olomouc, Czechia, 779 00
        • Recruiting
        • Fakultní Nemocnice Olomouc
        • Principal Investigator:
          • Katerina Bouchalova
      • Praha 2, Czechia, 12808
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
        • Principal Investigator:
          • Pavla Dolezalova
    • Brno-město
      • Brno, Brno-město, Czechia, 613 00
        • Recruiting
        • Detska nemocnice FN Brno
        • Principal Investigator:
          • Marcel Schuller
  • Denmark
    • Midtjylland
      • Aarhus, Midtjylland, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital, Skejby
        • Principal Investigator:
          • Mia Glerup
  • France
      • Paris, France, 75015
        • Recruiting
        • Hôpital Universitaire Necker Enfants Malades
        • Principal Investigator:
          • Pierre Quartier Dit Maire
    • Gard
      • Nîmes, Gard, France, 30029
        • Recruiting
        • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
        • Principal Investigator:
          • Tu-Anh TRAN
    • Paris
      • Le Kremlin-Bicêtre, Paris, France, 94270
        • Recruiting
        • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
        • Principal Investigator:
          • isabelle Kone-Paut
    • Rhône-Alpes
      • Bron, Rhône-Alpes, France, 69500
        • Recruiting
        • Hospices Civils de Lyon - Hôpital Femme Mère Enfant
        • Principal Investigator:
          • Alexandre BELOT
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers
        • Principal Investigator:
          • Elisabeth Gervais
  • India
    • Delhi
      • New Delhi, Delhi, India, 110060
        • Recruiting
        • Sir Ganga Ram Hospital
        • Principal Investigator:
          • Sujata Sawhney
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600116
        • Recruiting
        • Sri Ramachandra MedicaL College & Research Institute
        • Principal Investigator:
          • Mahesh Janarthanan
      • Vellore, Tamil Nadu, India, 632 004
        • Recruiting
        • Christian Medical College Vellore
        • Contact:
          • Phone Number: 9488469989
        • Principal Investigator:
          • Sathish Sathish Kumar
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014
        • Recruiting
        • Sanjay Gandhi Post Graduate Institute of Medical Sciences
        • Principal Investigator:
          • Amita Aggarwal
  • Israel
    • HaMerkaz
      • Kfar Saba, HaMerkaz, Israel, 4428164
        • Recruiting
        • Meir Medical Center
        • Principal Investigator:
          • Ruby Haviv
      • Petah Tikva, HaMerkaz, Israel, 49202
        • Recruiting
        • Schneider Children's Medical Center
        • Principal Investigator:
          • Gil Amarilyo
      • Ramat Gan, HaMerkaz, Israel, 5262100
        • Recruiting
        • Sheba Medical Center
        • Principal Investigator:
          • Irit Tirosh
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Ospedaliera Spedali Civili di Brescia
        • Principal Investigator:
          • Marco Cattalini
      • Chieti, Italy, 66100
        • Recruiting
        • Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
        • Principal Investigator:
          • Luciana Breda
      • MilanoLombardia, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
        • Principal Investigator:
          • Giovanni Filocamo
      • Trieste, Italy, 34137
        • Recruiting
        • Ospedale Infantile Burlo Garofolo
        • Principal Investigator:
          • Alberto Tommasini
    • Campania
      • Napoli, Campania, Italy, 80131
        • Recruiting
        • University of Naples Federico II
        • Principal Investigator:
          • Maria Alessio
    • Liguria
      • Genova, Liguria, Italy, 16147
        • Recruiting
        • IRCCS Istituto Giannina Gaslini
        • Principal Investigator:
          • Roberta Caorsi
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Recruiting
        • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
        • Principal Investigator:
          • Achille Marino
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
        • Recruiting
        • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
        • Contact:
          • Phone Number: 3909109166662
        • Principal Investigator:
          • Maria Cristina Maggio
  • Japan
      • Chiba, Japan, 266-0007
        • Recruiting
        • Chiba Children's Hospital
        • Principal Investigator:
          • Minako Tomiita
      • Kagoshima, Japan, 890-8520
        • Recruiting
        • Kagoshima University Hospital
        • Principal Investigator:
          • Yuichi Yamasaki
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0004
        • Recruiting
        • Yokohama City University Hospital
        • Principal Investigator:
          • Shuichi Ito
      • Yokohama, Kanagawa, Japan, 232-8555
        • Recruiting
        • Kanagawa Children's Medical Center
        • Principal Investigator:
          • Tomoyuki Imagawa
    • Miyagi
      • Sendai, Miyagi, Japan, 989-3126
        • Recruiting
        • Miyagi Children's Hospital
        • Principal Investigator:
          • Hiroaki Umebayashi
    • Osaka
      • Takatsuki, Osaka, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
        • Principal Investigator:
          • Yuko Sugita
    • Tokyo
      • Bunkyō, Tokyo, Japan, 113-8510
        • Recruiting
        • Tokyo Medical And Dental University Medical Hospital
        • Principal Investigator:
          • Masaki Shimizu
  • Mexico
      • Chihuahua, Mexico, 31000
        • Recruiting
        • Investigacion y Biomedicina de Chihuahua
        • Principal Investigator:
          • Cesar Francisco Pacheco-Tena
      • Durango, Mexico, 34000
        • Recruiting
        • Instituto de Investigaciones Clínicas para la Salud
        • Principal Investigator:
          • Edgar Hernandez
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06700
        • Recruiting
        • Clinstile, S.A. de C.V.
        • Principal Investigator:
          • Favio Edmundo Enriquez Sosa
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Recruiting
        • Crea de Guadalajara
        • Principal Investigator:
          • Gabriel Vega Cornejo
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66460
        • Recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
        • Principal Investigator:
          • Nadina Rubio Perez
  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-637
        • Recruiting
        • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
        • Principal Investigator:
          • Piotr Gietka
    • Małopolskie
      • Krakow, Małopolskie, Poland, 31-503
        • Recruiting
        • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
        • Principal Investigator:
          • Zbigniew Zuber
    • Łódzkie
      • Łódź, Łódzkie, Poland, 91-738
        • Recruiting
        • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
        • Principal Investigator:
          • Elzbieta Smolewska
  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Rosa Alcobendas
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen Del Rocio
        • Principal Investigator:
          • Marisol Camacho Lovillo
      • València, Spain, 46026
        • Recruiting
        • Hospital Universitari I Politecnic La Fe
        • Principal Investigator:
          • Inmaculada Calvo Penades
    • Barcelona [Barcelona]
      • Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
        • Recruiting
        • Hospital Sant Joan de Deu
        • Principal Investigator:
          • Jordi Anton
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon Y Cajal
        • Principal Investigator:
          • Alina Lucica Boteanu
      • Madrid, Madrid, Comunidad De, Spain, 28009
        • Recruiting
        • Hospital Infantil Universitario Niño Jesús
        • Principal Investigator:
          • DANIEL CLEMENTE
  • Turkey
      • Istanbul, Turkey, 34098
        • Recruiting
        • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
        • Principal Investigator:
          • Ozgur Kasapcopur
      • Izmir, Turkey, 35340
        • Recruiting
        • 9 Eylul University Hospital
        • Principal Investigator:
          • Erbil Unsal
  • United Kingdom
      • Sheffield, United Kingdom, S10 2TH
        • Recruiting
        • Sheffield Children's Hospital
        • Principal Investigator:
          • Daniel Philip Hawley
    • Bristol, City Of
      • Bristol, Bristol, City Of, United Kingdom, BS2 8BJ
        • Recruiting
        • Bristol Royal Hospital for Children
        • Principal Investigator:
          • Athimalaipet Ramanan
    • Camden
      • London, Camden, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital For Children NHS Foundation Trust
        • Principal Investigator:
          • Muthana Al Obaidi
    • England
      • Liverpool, England, United Kingdom, L12 2AB
        • Recruiting
        • Alder Hey Children's Hospital
        • Principal Investigator:
          • Beverley Almeida
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7HE
        • Recruiting
        • Oxford University Hospitals - Nuffield Orthopaedic Centre
        • Principal Investigator:
          • Akhila Kavirayani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.

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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Baricitinib
Baricitinib given orally.
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104
Placebo Comparator: Placebo
Placebo given orally.
Drug: Placebo
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Disease Flare
Time Frame: Week 24 to End of Double Blind Withdrawal (DBW) Period (Disease Flare or up to Week 56)
Time to Disease Flare
Week 24 to End of Double Blind Withdrawal (DBW) Period (Disease Flare or up to Week 56)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56)
Percentage of Participants Achieving PedACR30
Baseline through End of DBW Period (Disease Flare or up to Week 56)
Percentage of Participants with Inactive Disease
Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56)
Percentage of Participants with Inactive Disease
Baseline through End of DBW Period (Disease Flare or up to Week 56)
Percentage of Participants with Minimal Disease Activity
Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56)
Percentage of Participants with Minimal Disease Activity
Baseline through End of DBW Period (Disease Flare or up to Week 56)
Percentage of Participants in Remission
Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56)
Percentage of Participants in Remission
Baseline through End of DBW Period (Disease Flare or up to Week 56)
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27
Time Frame: Baseline, End of DBW Period (Disease Flare or up to Week 56)
Change from Baseline in JADAS-27
Baseline, End of DBW Period (Disease Flare or up to Week 56)
Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item
Time Frame: Baseline, End of DBW Period (Disease Flare or up to Week 56)
Change from Baseline in Arthritis-Related Pain Severity as Measured by the CHAQ Pain VAS Item
Baseline, End of DBW Period (Disease Flare or up to Week 56)
Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)
Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56)
PK: Cmax, ss of Baricitinib
Baseline through End of DBW Period (Disease Flare or up to Week 56)
PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss)
Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56)
PK: AUC, ss of Baricitinib
Baseline through End of DBW Period (Disease Flare or up to Week 56)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2020

Primary Completion (Estimated)

October 27, 2025

Study Completion (Estimated)

October 27, 2025

Study Registration Dates

First Submitted

September 11, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16275
  • I4V-MC-JAHU (Other Identifier: Eli Lilly and Company)
  • 2017-004495-60 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Juvenile Idiopathic Arthritis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe