Recruiting

A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

I4V-MC-JAHW - ClinicalTrials.gov - NCT04088409

The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.
How long will I be in the trial?
The study will last about 284 weeks and may include 30 visits.
Email
Recruiting

A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

I4V-MC-JAHW - ClinicalTrials.gov - NCT04088409

The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.
How long will I be in the trial?
The study will last about 284 weeks and may include 30 visits.
Email

Key Requirements

Age :

2-17

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

2-17

Sex

All

Participants must

Participants must have a diagnosis of JIA-U or chronic anterior antinuclear antibody (ANA) positive uveitis without systemic features

Participants must have active anterior uveitis

Participants must have an inadequate response or intolerance to MTX

Participants must be on a stable dose of corticosteroid eye drops

Participants and their partners must be willing to use two forms of birth control

Participants must NOT

Participants must not have of any autoimmune inflammatory condition other than JIA

Participants must not have had eye surgery within the 3 months

Participants must not have an infection

Participants must not have hepatitis B or tuberculosis (TB)

Trial Summary

Conditions the trial is for

Uveitis, Pediatric Uveitis

What the trial is testing?

Baricitinib, Adalimumab

Could I receive a Placebo?

no

Enrollment Goal

40

Trial Dates

October 2019 - December 2027

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

2-17

Sex

All

Participants must

Participants must have a diagnosis of JIA-U or chronic anterior antinuclear antibody (ANA) positive uveitis without systemic features

Participants must have active anterior uveitis

Participants must have an inadequate response or intolerance to MTX

Participants must be on a stable dose of corticosteroid eye drops

Participants and their partners must be willing to use two forms of birth control

Participants must NOT

Participants must not have of any autoimmune inflammatory condition other than JIA

Participants must not have had eye surgery within the 3 months

Participants must not have an infection

Participants must not have hepatitis B or tuberculosis (TB)

Trial Summary

Conditions the trial is for

Uveitis, Pediatric Uveitis

What the trial is testing?

Baricitinib, Adalimumab

Could I receive a Placebo?

no

Enrollment Goal

40

Trial Dates

October 2019 - December 2027

Trial Phase

3

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Trial Locations

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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?