Study of Baricitinib and Adalimumab for Children Aged 2 to 17 with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

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What is this study about?

This clinical trial is focused on studying the safety and effectiveness of the medication Baricitinib in children and teenagers aged 2 to less than 18 years who have active Juvenile Idiopathic Arthritis-associated Uveitis or chronic anterior antinuclear antibody-positive Uveitis. Uveitis is an inflammation of the middle layer of the eye, which can cause pain, redness, and vision problems. The study aims to determine if taking Baricitinib orally can help manage these conditions.

Participants in the study will receive Baricitinib, which is available in tablet form, and will be monitored over a period of time to assess its impact on their condition. The study will compare the effects of Baricitinib with those of other treatments, including a placebo, to evaluate its safety and effectiveness. The treatment period for Baricitinib can last up to 284 days, depending on the participant’s response to the medication.

The study is designed to observe changes in the level of eye inflammation, using criteria that measure the decrease in inflammation over time. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather data on how well the treatment works. This research is important for understanding how Baricitinib can be used to help young patients with these specific types of Uveitis.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm the diagnosis of juvenile idiopathic arthritis-associated uveitis or chronic anterior antinuclear antibody-positive uveitis.

The assessment includes verifying active anterior uveitis, defined by a specific level of inflammation in the eye, despite previous treatments.

2 medication administration

Participants receive baricitinib, an oral medication, to evaluate its safety and effectiveness.

The dosage and frequency of baricitinib are determined based on the participant’s age and specific medical condition.

3 ongoing monitoring

Regular monitoring is conducted to assess the response to the medication, focusing on the reduction of inflammation in the eye.

The primary goal is a significant decrease in inflammation, as defined by specific criteria, over a 24-week period.

4 completion of study

The study is expected to continue until July 2028, with participants monitored throughout the duration for any changes in their condition.

Upon completion, the effectiveness and safety of baricitinib will be evaluated based on the collected data.

Who Can Join the Study?

Participants must have a diagnosis of JIA-U (Juvenile Idiopathic Arthritis-associated Uveitis) or chronic anterior antibody-positive uveitis without other body symptoms.
Participants must have active anterior uveitis, which means inflammation in the front part of the eye, even after using enough eye drop steroids and a medicine called methotrexate (MTX).
Participants must not respond well to or cannot tolerate MTX.
Participants must be using a stable dose of corticosteroid eye drops for at least 2 weeks before the study starts, with no more than 4 drops per day per eye.
Participants and their partners who can have children must agree to use 2 effective birth control methods during the study and for at least 1 week after the last dose of the study drug.

Who Cannot Join the Study?

Participants who are not between 2 years and less than 18 years old cannot join the study.
Participants who do not have active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis are not eligible.
Participants who are not able to take the study drug orally cannot participate.
Participants who have any other medical condition that might interfere with the study or the safety of the participant may be excluded.
Participants who are pregnant or breastfeeding cannot take part in the study.
Participants who are currently participating in another clinical trial may not be eligible.
Participants who have a history of allergic reactions to similar drugs may be excluded.
Participants who have a serious infection or other serious health issues may not be allowed to join.
Participants who have had recent surgery or plan to have surgery during the study period may be excluded.
Participants who are unable to follow the study procedures or attend study visits may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hlqsixjbk Zquynkk flcf Kgppnua uyk Jzrqqlhsfewycehkjoy	Hamburg	Germany
Fmnzzogdr Paer La Ikmhtloumskdd Buugzxnhc Dwf Hytimdgi Urwcyeyqrxtlo Ly Pmn	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	27.11.2019
Italy	Recruiting	27.11.2019
Spain	Recruiting	27.11.2019

Trial locations

Investigated drugs:

Baricitinib is a medication being studied to see if it is safe and effective for children and teenagers with certain types of eye inflammation related to juvenile idiopathic arthritis. It is taken by mouth and is being tested to help reduce inflammation and improve symptoms in these young patients.

Investigated diseases:

Uveitis

Uveitis – Uveitis is an inflammation of the uvea, the middle layer of the eye, which includes the iris, ciliary body, and choroid. This condition can cause redness, pain, light sensitivity, and blurred vision. It may affect one or both eyes and can occur at any age. Uveitis can be associated with autoimmune disorders, infections, or trauma, but sometimes the cause is unknown. The inflammation can lead to complications such as glaucoma, cataracts, or vision loss if not managed properly. The progression of uveitis varies, with some cases resolving quickly while others may become chronic.

Trial ID:

2023-505811-18-00

Protocol code:

I4V-MC-JAHW

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Baricitinib and Adalimumab for Children Aged 2 to 17 with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?