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NCT Number: NCT03773965

A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

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.

Recruiting

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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto CAICI SRL, Rosario, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baricitinib

Drug

Administered orally.

Other names: LY3009104

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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)

Acronym: JUVE-X

Important dates

Study start
2019
Primary completion
2031
Study completion
2031
First posted
Dec 12, 2018
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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