Recruiting

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

I4V-MC-JAHU - ClinicalTrials.gov - NCT04088396

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).
How long will I be in the trial?
The study will last about 164 weeks and may include up to 30 visits.
Email
Recruiting

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

I4V-MC-JAHU - ClinicalTrials.gov - NCT04088396

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).
How long will I be in the trial?
The study will last about 164 weeks and may include up to 30 visits.
Email

Key Requirements

Age :

1-17

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

1-17

Sex

All

Participants must

Participants must have systemic Juvenile Idiopathic Arthritis (sJIA) with onset before the age of 16 years

Participants must have arthritis in a joint and fever lasting 2 weeks, with daily fever for 3 days, and at least 1 of the following: Evanescent erythematous rash, generalized lymph node enlargement, enlarged liver/spleen, serositis

Participants must have at least 2 active joints

Participants must NOT

Participants must not have polyarticular JIA, extended oligoarticular JIA, enthesitis-related JIA or juvenile psoriatic arthritis

Participants must not have persistent oligoarticular arthritis

Participants must not have any autoimmune inflammatory condition other than JIA

Participants must not have active anterior uveitis

Participants must not have active fibromyalgia or other chronic pain conditions

Participants must not have an infection

Participants must not have hepatitis B or tuberculosis (TB)

Trial Summary

Conditions the trial is for

Systemic Juvenile Idiopathic Arthritis

What the trial is testing?

Baricitinib, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

103

Trial Dates

February 2020 - August 2023

Trial Phase

3

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

1-17

Sex

All

Participants must

Participants must have systemic Juvenile Idiopathic Arthritis (sJIA) with onset before the age of 16 years

Participants must have arthritis in a joint and fever lasting 2 weeks, with daily fever for 3 days, and at least 1 of the following: Evanescent erythematous rash, generalized lymph node enlargement, enlarged liver/spleen, serositis

Participants must have at least 2 active joints

Participants must NOT

Participants must not have polyarticular JIA, extended oligoarticular JIA, enthesitis-related JIA or juvenile psoriatic arthritis

Participants must not have persistent oligoarticular arthritis

Participants must not have any autoimmune inflammatory condition other than JIA

Participants must not have active anterior uveitis

Participants must not have active fibromyalgia or other chronic pain conditions

Participants must not have an infection

Participants must not have hepatitis B or tuberculosis (TB)

Trial Summary

Conditions the trial is for

Systemic Juvenile Idiopathic Arthritis

What the trial is testing?

Baricitinib, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

103

Trial Dates

February 2020 - August 2023

Trial Phase

3

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Trial Locations

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Systemic Juvenile Idiopathic Arthritis Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?