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Trial record 7 of 62 for:    Baricitinib

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

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ClinicalTrials.gov Identifier: NCT04088396
Recruitment Status : Not yet recruiting
First Posted : September 12, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 11, 2019
First Posted Date  ICMJE September 12, 2019
Last Update Posted Date December 3, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date April 7, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04088396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
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 (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Systemic Juvenile Idiopathic Arthritis
Intervention  ICMJE
  • Drug: Baricitinib
    Administered orally
    Other Name: LY3009104
  • Drug: Placebo
    Administered orally
Study Arms  ICMJE
  • Experimental: Baricitinib
    Baricitinib given orally.
    Intervention: Drug: Baricitinib
  • Placebo Comparator: Placebo
    Placebo given orally.
    Intervention: Drug: Placebo
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2019)
103
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 7, 2023
Estimated Primary Completion Date April 7, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 arthritis in 1 or more joints with or preceded by fever of at least 2 weeks' duration that is documented to be daily (quotidian) fever for at least 3 days, and accompanied by 1 or more of the following:

    • Evanescent (nonfixed) erythematous rash
    • Generalized lymph node enlargement
    • Hepatomegaly and/or splenomegaly
    • Serositis
  • 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, such as Crohn's disease or ulcerative colitis.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 17 Years   (Child)
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,   Austria,   Belgium,   Brazil,   Czechia,   Denmark,   France,   Germany,   India,   Israel,   Italy,   Japan,   Mexico,   Poland,   Russian Federation,   Spain,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04088396
Other Study ID Numbers  ICMJE 16275
I4V-MC-JAHU ( Other Identifier: Eli Lilly and Company )
2017-004495-60 ( 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.vivli.org/
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 December 1, 2019

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