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

ConditionSystemic Juvenile Idiopathic Arthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-17
SponsorEli Lilly and Company

About this trial

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). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 at least 2 active joints at screening and baseline

Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age

Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age

Disqualifiers

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

Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Baricitinib

    Drug

    Administered orally

  • Tocilizumab

    Drug

    Administered SC

Treatment groups

58 Participants
are divided into 3 treatment groups
Group A: Cohort 1 BaricitinibExperimental treatment 1 intervention
Group B: Cohort 1 TocilizumabActive comparator 1 intervention
Group C: Cohort 2 BaricitinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12

Percentage of Participants Achieving Adapted PediACR30 Response Criteria

Time frame
Week 12

Secondary outcomes

1

Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24

Percentage of Participants Achieving Adapted PediACR30 Response Criteria

Time frame
Week 24
2

Percentage of Participants with Inactive Disease

Percentage of Participants with Inactive Disease

Time frame
Week 12
3

Percentage of Participants with Minimal Disease Activity

Percentage of Participants with Minimal Disease Activity

Time frame
Week 12
4

Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27

Change from Baseline in JADAS-27

Time frame
Baseline, Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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