Recruiting

Study on the Safety and Effectiveness of Baricitinib for Children Aged 1 to 17 with Juvenile Idiopathic Arthritis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety and effectiveness of a medication called baricitinib in treating a condition known as Juvenile Idiopathic Arthritis (JIA). JIA is a type of arthritis that affects children, causing joint pain and inflammation. The study involves participants aged 1 to less than 18 years who have previously been treated with baricitinib for JIA.

The purpose of the study is to determine if baricitinib is safe and effective for children with JIA. Participants will receive the medication in the form of a tablet or oral suspension, which means it is taken by mouth. The study will monitor the participants over a period to observe any side effects and to see how well the medication works in managing the symptoms of JIA.

Throughout the study, some participants may receive a placebo, which is a substance with no active medication, to compare the effects of baricitinib. The study aims to gather information on the number of participants who experience serious side effects or need to stop taking the medication permanently. This information will help in understanding the long-term use of baricitinib in treating JIA in children.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after completing a previous study of baricitinib for juvenile idiopathic arthritis.
Eligibility requires no allergy to baricitinib.
Step 2
Medication administration
Baricitinib is administered orally.
The medication is available in tablet form or as an oral suspension.
Dosage and frequency are determined by the study protocol and the participant's specific needs.
Step 3
Monitoring and evaluation
The study aims to evaluate the long-term safety and effectiveness of baricitinib.
Participants are monitored for any serious adverse events (SAEs).
The number of participants who discontinue the investigational product permanently is recorded.
Step 4
Study duration
The study is estimated to conclude by December 18, 2030.
Participants will be involved in the study until its completion or until they meet criteria for discontinuation.

Who can join the trial?

4 criteria

Participants must have completed a previous study of the study drug, baricitinib, for the treatment of Juvenile Idiopathic Arthritis (JIA). JIA is a type of arthritis that affects children.
Participants must not have developed an allergy to baricitinib. An allergy is when your body reacts badly to something, causing symptoms like itching or swelling.
Participants must be between the ages of 1 and 17 years old.
Both male and female participants are eligible to join the study.

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Verified sites

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Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

Trial locations

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Investigated drugs

Baricitinib is a medication being studied for its safety and effectiveness in treating Juvenile Idiopathic Arthritis (JIA) in children and adolescents aged 1 to 17 years. It works by targeting specific pathways in the immune system that are involved in inflammation, which is a key factor in JIA. The goal of the study is to determine if this medication can help reduce symptoms and improve the quality of life for young patients with this condition.

Baricitinib

What is already known about the treatment

Baricitinib – Baricitinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its safety and effectiveness in treating Juvenile Idiopathic Arthritis (JIA) in children aged 1 to 17 years. The medication is primarily used to manage symptoms of JIA, such as joint pain and inflammation. At the molecular level, Baricitinib works by inhibiting specific enzymes known as Janus kinases (JAKs), which play a role in the inflammatory process. It is classified as a Janus kinase inhibitor in pharmacology.

Investigated diseases

Juvenile Idiopathic Arthritis – This is a type of arthritis that occurs in children under the age of 16. It is characterized by persistent joint inflammation, which can lead to pain, swelling, and stiffness. The disease can affect one or multiple joints and may also cause symptoms such as fever and rash. Over time, it can lead to joint damage and growth problems if not managed properly. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors. The progression of the disease can vary, with some children experiencing symptoms for only a few months, while others may have symptoms for many years.