Study on the Safety and Effectiveness of Baricitinib and Tocilizumab for Children with Systemic Juvenile Idiopathic Arthritis

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What is this study about?

This clinical trial is focused on studying a condition known as Systemic Juvenile Idiopathic Arthritis (sJIA), which is a type of arthritis that affects children. The study aims to evaluate the safety and effectiveness of a medication called Baricitinib in children aged 1 to less than 18 years who have this condition. Baricitinib is a medication that comes in different forms, including film-coated tablets and oral suspension, and is taken by mouth. Another medication involved in the study is Tocilizumab, which is given as a solution for injection under the skin. The study also includes a placebo, which is a substance with no active medication, to compare the effects of the treatments.

The purpose of the study is to assess how well Baricitinib works in treating children with sJIA. Participants in the study will receive either Baricitinib, Tocilizumab, or a placebo. The study will monitor the participants over a period to see how their condition responds to the treatment. The main goal is to see if the participants achieve a certain level of improvement in their symptoms by week 12 of the study.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how the medication affects their condition. The study is designed to provide valuable insights into the treatment of sJIA in children, potentially leading to better management of this condition in the future.

1 joining the study

Upon joining the study, the participant is confirmed to have a diagnosis of systemic juvenile idiopathic arthritis (sJIA) with symptoms such as arthritis in a joint, fever lasting 2 weeks, and at least one additional symptom like rash or enlarged organs.

2 initial assessment

An initial assessment is conducted to evaluate the participant’s health status and confirm eligibility based on the study criteria.

3 treatment phase

Participants receive baricitinib or tocilizumab as part of the treatment. Baricitinib is administered orally in the form of capsules or oral suspension, while tocilizumab is given as a subcutaneous injection.

The dosage and frequency of administration are determined by the study protocol and adjusted based on the participant’s response and tolerance.

4 monitoring and follow-up

Regular monitoring is conducted to assess the safety and efficacy of the treatment. This includes physical examinations, laboratory tests, and evaluation of symptoms.

Participants are monitored for any side effects or changes in their condition throughout the study duration.

5 evaluation of outcomes

The primary outcome is measured by the percentage of participants achieving the Adapted Pediatric American College of Rheumatology 30 (PediACR30) response criteria at week 12.

Secondary outcomes may include additional measures of improvement in symptoms and overall health.

6 completion of the study

The study is estimated to conclude by October 27, 2025. Participants will have a final assessment to evaluate the long-term effects of the treatment.

Who Can Join the Study?

Participants must have a diagnosis of Systemic Juvenile Idiopathic Arthritis (sJIA), which is a type of arthritis that starts before the age of 16.
Participants must have arthritis in a joint and a fever that lasts for 2 weeks, with a daily fever for at least 3 days. They must also have at least one of the following: a temporary red rash, swollen lymph nodes, an enlarged liver or spleen, or inflammation around the heart or lungs (known as serositis).
Participants must have at least 2 joints that are actively affected by arthritis.
Participants must be at least 2 years old.
Both boys and girls can participate in the study.

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 required visits.
Patients who have participated in another clinical trial recently.
Patients who are pregnant or breastfeeding.
Patients who have a history of substance abuse or alcohol dependency.
Patients who have been diagnosed with a mental health condition that could affect their ability to participate.
Patients who have received certain vaccines recently.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher	Warsaw	Poland

Verified Sites

Site Name	City	Country
Hopital Necker Enfants Malades	Paris	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Medical University Of Vienna	Vienna	Austria
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
ARNAS Civico Di Cristina Benfratelli	Palermo	Italy
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo	Trieste	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Fakultni Nemocnice Brno	Brno	Czechia
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti	Chieti	Italy
University Hospital Olomouc	Olomouc	Czechia
Centre Hospitalier Lyon Sud	Pierre Benite	France
Universita Degli Studi Di Brescia	Brescia	Italy
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto	Milan	Italy
Bicetre Hospital	Le Kremlin-Bicetre	France
CSK, Uniwersyteckie Centrum Pediatrii im. M.Konopnickiej	Lodz	Poland
Ceyuxyywp Umnljjbbqcqwqo Szpenyves	Woluwe-Saint-Lambert	Belgium
Sfyvkaw Dsnwcaxdb Sfc Lsmxpwc Iyx Okpjyzv Kbpukqhny Pngvmkgse Rugkintgjurj z psyvmkuvdevh avrlfvhjqo	Cracow	Poland
Fwtiqokmg Ptdi Lf Ihajugqinoffn Bxshlqjut Dck Hqzerqrg Ugznrrqoeyknf Lo Pse	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	19.06.2020
Belgium	Not recruiting	19.06.2020
Czechia	Not recruiting	19.06.2020
France	Not recruiting	19.06.2020
Italy	Not recruiting	19.06.2020
Poland	Not recruiting	19.06.2020
Spain	Not recruiting	19.06.2020

Trial locations

Investigated drugs:

Baricitinib is a medication being studied for its effectiveness in treating children with systemic juvenile idiopathic arthritis (sJIA). It works by reducing inflammation and helping to control the symptoms of arthritis.

Tocilizumab is used as a reference medication in this study. It is already known to help manage symptoms of systemic juvenile idiopathic arthritis by blocking a specific protein in the body that causes inflammation.

Systemic Juvenile Idiopathic Arthritis – 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 a skin rash. It is called “systemic” because it can affect the entire body, not just the joints. The disease often begins with a fever that spikes once or twice a day, and a rash that may come and go. Over time, it can lead to joint pain and swelling, which may result in stiffness and reduced movement. The condition can also cause inflammation in other parts of the body, such as the heart or lungs. The progression of symptoms can vary widely among individuals, with some experiencing mild symptoms and others having more severe manifestations.

Trial ID:

2023-507883-38-00

Protocol code:

I4V-MC-JAHU

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Baricitinib and Tocilizumab for Children with Systemic Juvenile Idiopathic Arthritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?