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A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JUVE-X)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773965
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE December 11, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE April 5, 2019
Estimated Primary Completion Date December 6, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) [ Time Frame: Baseline through Week 264 ]
    Number of participants with one or more SAEs
  • Number of Participants with Permanent Investigational Product Discontinuations [ Time Frame: Baseline through Week 264 ]
    Number of participants with permanent investigational product discontinuations
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Week 264 ]
    Number of participants with DLTs
  • Number of Participants with Permanent Investigational Product Discontinuations [ Time Frame: Baseline through Week 264 ]
    Number of participants with permanent investigational product discontinuations
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) [ Time Frame: Week 264 ]
    Proportion of participants achieving PedACR30
  • Proportion of Participants who have Disease Flare [ Time Frame: Baseline through Week 264 ]
    Proportion of participants who have disease flare
  • Proportion of Participants with Inactive Disease [ Time Frame: Week 264 ]
    Proportion of participants with inactive disease
  • Proportion of Participants with Minimal Disease Activity [ Time Frame: Week 264 ]
    Proportion of participants with minimal disease activity
  • Proportion of Participants in Remission [ Time Frame: Week 264 ]
    Proportion of participants in remission
  • Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27) [ Time Frame: Baseline, Week 264 ]
    Change from baseline of originating study in JADAS27
  • 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, Week 264 ]
    Change from baseline in arthritis-related pain severity as measured by the CHAQ pain VAS item
  • Change from Baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline, Week 264 ]
    Change from baseline in PASI
  • Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index [ Time Frame: Baseline, Week 264 ]
    Change from baseline in SPARCC enthesitis index
  • Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA) [ Time Frame: Baseline, Week 264 ]
    Change from baseline in JSpADA
  • Change from Baseline in Immunoglobulin Levels [ Time Frame: Baseline, Week 264 ]
    Change from baseline in immunoglobulin levels
  • Change from Baseline in Immunophenotyping (T Cells) [ Time Frame: Baseline, Week 264 ]
    Change from baseline in immunophenotyping (T Cells)
  • Change of Immunoglobulin G (IgG) Titers [ Time Frame: Pre-Vaccination to 12 Weeks Post-Vaccination ]
    Change of IgG titers
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Official Title  ICMJE A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA)
Brief Summary The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Juvenile Idiopathic Arthritis
Intervention  ICMJE Drug: Baricitinib
Administered orally.
Other Name: LY3009104
Study Arms  ICMJE Experimental: Baricitinib
Baricitinib given orally.
Intervention: Drug: Baricitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
190
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 6, 2027
Estimated Primary Completion Date December 6, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must have completed a previous study of baricitinib for the treatment of JIA.

Exclusion Criteria:

  • Participants must not have had a permanent discontinuation of baricitinib in the prior study.
  • Participants must have not developed an allergy to baricitinib.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   China,   Czechia,   Denmark,   France,   Germany,   India,   Israel,   Italy,   Japan,   Mexico,   Poland,   Russian Federation,   Spain,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773965
Other Study ID Numbers  ICMJE 16278
I4V-MC-JAHX ( Other Identifier: Eli Lilly and Company )
2017-004471-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP