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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-18
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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have completed a previous study of baricitinib for the treatment of JIA.

Disqualifiers

Participants must not have had a permanent discontinuation of baricitinib in the prior study.

Participants must have not developed an allergy to baricitinib.

Trial design

Design model

Single group

Treatments tested in this trial

  • Baricitinib

    Drug

    Administered orally.

Treatment groups

190 Participants
are divided into 1 treatment group
Group A: BaricitinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with One or More Serious Adverse Event(s) (SAEs)

Number of participants with one or more SAEs

Time frame
Baseline through Week 264
2

Number of Participants with Permanent Investigational Product Discontinuations

Number of participants with permanent investigational product discontinuations

Time frame
Baseline through Week 264

Secondary outcomes

1

Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)

Proportion of participants achieving PedACR30

Time frame
Week 264
2

Proportion of Participants who have Disease Flare

Proportion of participants who have disease flare

Time frame
Baseline through Week 264
3

Proportion of Participants with Inactive Disease

Proportion of participants with inactive disease

Time frame
Week 264
4

Proportion of Participants with Minimal Disease Activity

Proportion of participants with minimal disease activity

Time frame
Week 264

Other outcomes

Sponsors and contacts

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