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Study of Sarilumab for Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)

Verified siteInvestigationalNo 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 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.

  1. Step 1

    Initial treatment phase

    The study begins with the administration of sarilumab, a medication given as a solution for injection under the skin. This phase is designed to find the right dose for children and adolescents aged 1 to 17 years with systemic juvenile idiopathic arthritis (sJIA).

    During this phase, the medication is administered repeatedly, and the effects are monitored closely. The primary goal is to understand how the body processes the medication, which is referred to as the pharmacokinetic profile.

  2. Step 2

    Core treatment phase

    This phase lasts up to 12 weeks. The focus is on assessing the maximum concentration of the medication in the blood, the area under the concentration-time curve, and the concentration before the next dose.

    The number of adverse events and the local tolerability of the medication are also evaluated. Additionally, changes in disease activity and overall wellbeing are measured using specific assessment tools.

  3. Step 3

    Extension phase

    Following the core treatment phase, the extension phase continues up to week 156. This phase allows for long-term observation of the medication's effects and safety.

    Assessments include the response rate to treatment, changes in disease activity, and the use of glucocorticoids, which are medications that reduce inflammation. The goal is to determine the long-term benefits and risks of the treatment.

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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Investigated drugs

Sarilumab is a medication being studied for its effects on children and adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA). It is given through an injection under the skin. The goal of the study is to understand how the body processes this medication in young patients and to find the right dose and schedule for treating sJIA effectively.

What is already known about the treatment

Sarilumab – Sarilumab is administered through subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating Systemic Juvenile Idiopathic Arthritis (sJIA) in children and adolescents aged 1 to 17 years. It is an investigational medication, meaning it is still under research and not yet fully approved for this use in medical practice. The main therapeutic indication for sarilumab in this trial is to manage symptoms of sJIA, a type of arthritis that affects children. At the molecular level, sarilumab works by blocking the interleukin-6 (IL-6) receptor, which plays a role in inflammation and immune response. It is classified pharmacologically as an interleukin inhibitor.

Investigated diseases

Systemic Juvenile Idiopathic Arthritis (sJIA) – This is a type of arthritis that affects children and is characterized by inflammation in one or more joints, along with a high fever and rash. It is a systemic condition, meaning it can affect the entire body, including internal organs. The disease often begins with a fever that spikes once or twice a day, and a salmon-colored rash may appear on the skin. Over time, joint pain and swelling can develop, leading to stiffness and reduced movement. The condition can vary greatly in severity, with some children experiencing mild symptoms and others having more severe, persistent issues. The exact cause of sJIA is unknown, but it is believed to involve both genetic and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2024-512701-11-00Protocol codeDRI13926Estimated enrolment82 patientsSponsorSanofi-Aventis Recherche & Developpement

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