Study of Sarilumab for Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)
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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 a condition called Systemic Juvenile Idiopathic Arthritis (sJIA), which affects children and adolescents. This is a type of arthritis that causes joint inflammation and can also lead to fever and rash. The study is testing a treatment called sarilumab, which is given as a solution for injection under the skin. Sarilumab is also known by its code name SAR153191/REGN88.
The purpose of the study is to understand how sarilumab behaves in the body of children and adolescents aged 1 to 17 years with sJIA. This will help determine the right dose and schedule for treating this condition. Participants in the study will receive repeated doses of sarilumab, and the study will include an initial phase followed by an extension phase. The study will monitor how the body processes the medication and will also look at the safety and tolerability of the treatment over time.
Throughout the study, researchers will assess various health indicators, such as the number of joints affected by arthritis and overall well-being, to see how the treatment impacts the condition. The study will also track any side effects experienced by participants. The goal is to gather comprehensive information to help improve treatment options for children and adolescents with sJIA.
The research process
The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
4 criteria
- Patients must be boys or girls aged between 1 and 17 years old. In Russia, the age requirement is between 12 and 17 years old.
- Patients must have a diagnosis of **Systemic Juvenile Idiopathic Arthritis (sJIA)**. This is a type of arthritis that affects children and causes joint inflammation and other symptoms.
- Patients must have at least 5 active joints with arthritis at the time of screening. If they have fewer than 5 active joints, they must have a fever higher than 37.5°C in the 3 days before the start of the study or for at least 3 out of any 7 consecutive days during screening, even if they are taking **glucocorticoids**. Glucocorticoids are a type of medication used to reduce inflammation.
- Patients must not be responding well to their current treatment and should be considered suitable for a **biologic disease-modifying anti-rheumatic drug (DMARD)**. This is a type of medication that helps to slow down the progression of arthritis.
Who cannot join the trial?
9 criteria
- Patients who have any other serious health conditions that could interfere with the study.
- Patients who are currently taking medications that might affect the study results.
- Patients who have had a recent infection or illness that could impact their participation.
- Patients who have a history of allergic reactions to similar medications.
- Patients who are unable to follow the study procedures or attend the required visits.
- Patients who have participated in another clinical trial recently.
- Patients who are pregnant or breastfeeding.
- Patients who have a history of drug or alcohol abuse.
- Patients who have any condition that the study doctors believe would make it unsafe for them to participate.
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