Back to resultsA Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA
Primary Purpose
Systemic Juvenile Idiopathic Arthritis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Baricitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Juvenile Idiopathic Arthritis focused on measuring Systemic, Fever, Flare, sJIA, JIA
Eligibility Criteria
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.
Sites / Locations
- Instituto CAICI SRLRecruiting
- Centro de Investigaciones Médicas TucumanRecruiting
- Hospital General de Niños Dr. Pedro de ElizaldeRecruiting
- Instituto da Crianca do Hospital das Clinicas da FMUSPRecruiting
- IPITECRecruiting
- Universidade Federal de Sao PauloRecruiting
- Aarhus Universitetshospital, SkejbyRecruiting
- Sri Ramachandra MedicaL College & Research InstituteRecruiting
- Christian Medical College VelloreRecruiting
- Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
- Kanagawa Children's Medical CenterRecruiting
- Miyagi Children's HospitalRecruiting
- Osaka Medical and Pharmaceutical University HospitalRecruiting
- Tokyo Medical And Dental University Medical HospitalRecruiting
- Kagoshima University HospitalRecruiting
- Clinstile, S.A. de C.V.Recruiting
- Crea de GuadalajaraRecruiting
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"Recruiting
- Investigacion y Biomedicina de ChihuahuaRecruiting
- Instituto de Investigaciones Clínicas para la SaludRecruiting
- Sheffield Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Baricitinib
Placebo
Arm Description
Baricitinib given orally.
Placebo given orally.
Outcomes
Primary Outcome Measures
Time to Disease Flare
Time to Disease Flare
Secondary Outcome Measures
Percentage of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
Percentage of Participants Achieving PedACR30
Percentage of Participants with Inactive Disease
Percentage of Participants with Inactive Disease
Percentage of Participants with Minimal Disease Activity
Percentage of Participants with Minimal Disease Activity
Percentage of Participants in Remission
Percentage of Participants in Remission
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27
Change from Baseline in JADAS-27
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
Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)
PK: Cmax, ss of Baricitinib
PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss)
PK: AUC, ss of Baricitinib
Full Information
NCT ID
NCT04088396
First Posted
September 11, 2019
Last Updated
October 3, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT04088396
Brief Title
A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
October 27, 2025 (Anticipated)
Study Completion Date
October 27, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Juvenile Idiopathic Arthritis
Keywords
Systemic, Fever, Flare, sJIA, JIA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
103 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Baricitinib
Arm Type
Experimental
Arm Description
Baricitinib given orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given orally.
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Other Intervention Name(s)
LY3009104
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Time to Disease Flare
Description
Time to Disease Flare
Time Frame
Week 24 to End of Double Blind Withdrawal (DBW) Period (Disease Flare or up to Week 56)
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
Description
Percentage of Participants Achieving PedACR30
Time Frame
Baseline through End of DBW Period (Disease Flare or up to Week 56)
Title
Percentage of Participants with Inactive Disease
Description
Percentage of Participants with Inactive Disease
Time Frame
Baseline through End of DBW Period (Disease Flare or up to Week 56)
Title
Percentage of Participants with Minimal Disease Activity
Description
Percentage of Participants with Minimal Disease Activity
Time Frame
Baseline through End of DBW Period (Disease Flare or up to Week 56)
Title
Percentage of Participants in Remission
Description
Percentage of Participants in Remission
Time Frame
Baseline through End of DBW Period (Disease Flare or up to Week 56)
Title
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27
Description
Change from Baseline in JADAS-27
Time Frame
Baseline, End of DBW Period (Disease Flare or up to Week 56)
Title
Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item
Description
Change from Baseline in Arthritis-Related Pain Severity as Measured by the CHAQ Pain VAS Item
Time Frame
Baseline, End of DBW Period (Disease Flare or up to Week 56)
Title
Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)
Description
PK: Cmax, ss of Baricitinib
Time Frame
Baseline through End of DBW Period (Disease Flare or up to Week 56)
Title
PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss)
Description
PK: AUC, ss of Baricitinib
Time Frame
Baseline through End of DBW Period (Disease Flare or up to Week 56)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Instituto CAICI SRL
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Oscar Viola
Facility Name
Centro de Investigaciones Médicas Tucuman
City
SAN M. DE Tucuman
State/Province
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Jorge Spindler
Facility Name
Hospital General de Niños Dr. Pedro de Elizalde
City
Buenos Aires
ZIP/Postal Code
1270
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruben José Cuttica
Facility Name
Instituto da Crianca do Hospital das Clinicas da FMUSP
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clovis Silva
Facility Name
IPITEC
City
São Paulo
ZIP/Postal Code
01223-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Carolina dos Santos
Facility Name
Universidade Federal de Sao Paulo
City
São Paulo
ZIP/Postal Code
04022-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Teresa Terreri
Facility Name
Aarhus Universitetshospital, Skejby
City
Aarhus
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mia Glerup
Facility Name
Sri Ramachandra MedicaL College & Research Institute
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600116
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahesh Janarthanan
Facility Name
Christian Medical College Vellore
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632 004
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
9488469989
First Name & Middle Initial & Last Name & Degree
Sathish Sathish Kumar
Facility Name
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
3909109166662
First Name & Middle Initial & Last Name & Degree
Maria Cristina Maggio
Facility Name
Kanagawa Children's Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-8555
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomoyuki Imagawa
Facility Name
Miyagi Children's Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
989-3126
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroaki Umebayashi
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuko Sugita
Facility Name
Tokyo Medical And Dental University Medical Hospital
City
Bunkyō
State/Province
Tokyo
ZIP/Postal Code
113-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masaki Shimizu
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuichi Yamasaki
Facility Name
Clinstile, S.A. de C.V.
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Favio Edmundo Enriquez Sosa
Facility Name
Crea de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Vega Cornejo
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
66460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadina Rubio Perez
Facility Name
Investigacion y Biomedicina de Chihuahua
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesar Francisco Pacheco-Tena
Facility Name
Instituto de Investigaciones Clínicas para la Salud
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgar Hernandez
Facility Name
Sheffield Children's Hospital
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Philip Hawley
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/4qr6645c2hmeJZWASkU2jH
Description
A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA
Learn more about this trial
A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA
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