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

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What is this study about?

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.

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 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 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 Study?

  • 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 Study?

  • 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.

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
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Nosokomeio Paidon I Agia Sofia Athens Greece
Gesundheit Nord gGmbH Klinikverbund Bremen Bremen Germany
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Hospital La Milagrosa S.A. Madrid Spain
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Asklepios Klinik Sankt Augustin GmbH Sankt Augustin Germany
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Spitalul Clinic De Urgenta Pentru Copii Cluj-Napoca Cluj Napoca Romania
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Our Lady’s Childrens Hospital Dublin Ireland
Pxyxhsgor Rfflbiwrobfz Iykvcaezeoqis Tixife Oytblmtitiwe Genoa Italy
Mbtgssum Hwcozpbs Helsinki Finland
Htkxmwrts Zwerczi fptp Klrzwdc uky Jvmosugkyprrdilfich Hamburg Germany
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Hiyrigrh Vfoy dskegthi Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not yet recruiting
08.09.2018
Finland Finland
Recruiting
08.09.2018
France France
Recruiting
08.09.2018
Germany Germany
Recruiting
08.09.2018
Greece Greece
Not yet recruiting
08.09.2018
Hungary Hungary
Not yet recruiting
08.09.2018
Ireland Ireland
Not yet recruiting
08.09.2018
Italy Italy
Recruiting
08.09.2018
Portugal Portugal
Not yet recruiting
08.09.2018
Romania Romania
Not yet recruiting
08.09.2018
Spain Spain
Recruiting
08.09.2018

Trial locations

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.

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 ID:
2024-512701-11-00
Protocol code:
DRI13926
NCT ID:
NCT02991469
Trial Phase:
Therapeutic exploratory (Phase II)

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