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Trial record 2 of 2 for:    NCT03773978

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

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ClinicalTrials.gov Identifier: NCT03773965
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Drug: Baricitinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : December 6, 2027
Estimated Study Completion Date : December 6, 2027


Arm Intervention/treatment
Experimental: Baricitinib
Baricitinib given orally.
Drug: Baricitinib
Administered orally.
Other Name: LY3009104




Primary Outcome Measures :
  1. 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

  2. Number of Participants with Permanent Investigational Product Discontinuations [ Time Frame: Baseline through Week 264 ]
    Number of participants with permanent investigational product discontinuations


Secondary Outcome Measures :
  1. Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) [ Time Frame: Week 264 ]
    Proportion of participants achieving PedACR30

  2. Proportion of Participants who have Disease Flare [ Time Frame: Baseline through Week 264 ]
    Proportion of participants who have disease flare

  3. Proportion of Participants with Inactive Disease [ Time Frame: Week 264 ]
    Proportion of participants with inactive disease

  4. Proportion of Participants with Minimal Disease Activity [ Time Frame: Week 264 ]
    Proportion of participants with minimal disease activity

  5. Proportion of Participants in Remission [ Time Frame: Week 264 ]
    Proportion of participants in remission

  6. Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27) [ Time Frame: Baseline, Week 264 ]
    Change from baseline of originating study in JADAS27

  7. 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

  8. Change from Baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline, Week 264 ]
    Change from baseline in PASI

  9. Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index [ Time Frame: Baseline, Week 264 ]
    Change from baseline in SPARCC enthesitis index

  10. Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA) [ Time Frame: Baseline, Week 264 ]
    Change from baseline in JSpADA

  11. Change from Baseline in Immunoglobulin Levels [ Time Frame: Baseline, Week 264 ]
    Change from baseline in immunoglobulin levels

  12. Change from Baseline in Immunophenotyping (T Cells) [ Time Frame: Baseline, Week 264 ]
    Change from baseline in immunophenotyping (T Cells)

  13. Change of Immunoglobulin G (IgG) Titers [ Time Frame: Pre-Vaccination to 12 Weeks Post-Vaccination ]
    Change of IgG titers



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773965


Contacts
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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

  Show 95 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03773965     History of Changes
Other Study ID Numbers: 16278
I4V-MC-JAHX ( Other Identifier: Eli Lilly and Company )
2017-004471-31 ( EudraCT Number )
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Polyarticular JIA
Oligoarthritis
Juvenile psoriatic arthritis (JPsA)
Enthesitis‑related juvenile idiopathic arthritis (ERA)
Systemic JIA with and without systemic features
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases