Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 62 for:    Baricitinib

A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JUVE-BASIS)

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: NCT03773978
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : November 5, 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 given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : August 21, 2021
Estimated Study Completion Date : August 21, 2021


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

Experimental: Baricitinib Double Blind
Baricitinib given orally.
Drug: Baricitinib
Administered orally.
Other Name: LY3009104

Placebo Comparator: Placebo Double Blind
Placebo given orally.
Drug: Placebo
Administered orally.




Primary Outcome Measures :
  1. Time to Disease Flare [ Time Frame: Week 12 to Week 44 ]
    Time to disease flare


Secondary Outcome Measures :
  1. Proportion of Participants Achieving Pediatric American College of Rheumatology 30 responder index (PedACR30) [ Time Frame: Week 12 to Week 44 ]
    Proportion of participants achieving PedACR30

  2. Proportion of Participants with Inactive Disease [ Time Frame: Week 12 to Week 44 ]
    Proportion of participants with inactive disease

  3. Proportion of Participants with Minimal Disease Activity [ Time Frame: Week 12 to Week 44 ]
    Proportion of participants with minimal disease activity

  4. Proportion of Participants in Remission [ Time Frame: Week 24 to Week 44 ]
    Proportion of participants in remission

  5. Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 [ Time Frame: Baseline, Week 44 ]
    Change from baseline in juvenile arthritis disease activity score

  6. 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 44 ]
    Change from baseline in arthritis-related pain severity as measured by the CHAQ pain VAS item

  7. Change from Baseline in Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Baseline, Week 44 ]
    Change from baseline in PASI score

  8. Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index [ Time Frame: Baseline, Week 44 ]
    Change from baseline in SPARCC enthesitis index

  9. Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA) [ Time Frame: Baseline, Week 44 ]
    Change from baseline in JSpADA

  10. Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss) [ Time Frame: Baseline through Week 44 ]
    PK: Cmax, ss of Baricitnib

  11. PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss) [ Time Frame: Baseline through Week 44 ]
    PK: AUC, ss of Baricitnib

  12. Change from Baseline in Immunophenotyping (T Cells) [ Time Frame: Baseline, Week 12 ]
    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 immunoglobulin G (IgG) titers

  14. Acceptability Assessment [ Time Frame: Week 44 ]
    Participants were evaluated for baricitinib acceptability using a 5-category questionnaire. Participants were asked to answer one of the following to describe the ease of use of baricitinib: Very difficult (or hard), difficult (or hard), neither easy nor hard, easy, or very easy.

  15. Palatability Assessment [ Time Frame: Week 44 ]
    Participants were evaluated for baricitinib palatability using a 5-category questionnaire. Participants were asked to answer one of the following to describe the taste and smell of baricitinib: Disliked very much, disliked, neither liked nor disliked, liked, or like very much.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have had a diagnosis of active JIA (polyarticular, extended oligoarticular, or enthesitis-related juvenile idiopathic arthritis [ERA] including JPsA).
  • Participants must have had an inadequate response to at least one conventional or biologic disease-modifying antirheumatic drug (DMARD).

Exclusion Criteria:

  • Participants must not have systemic JIA, with or without active systemic features.
  • Participants must not have persistent oligoarticular arthritis.
  • Participants must not have been previously treated with a Janus kinase (JAK) inhibitor.

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): NCT03773978


Contacts
Layout table for location contacts
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 91 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
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:
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03773978     History of Changes
Other Study ID Numbers: 16276
I4V-MC-JAHV ( Other Identifier: Eli Lilly and Company )
2017-004518-24 ( EudraCT Number )
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 1, 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

Layout table for additional information
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)
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases