Study on Upadacitinib and Tocilizumab for Children and Teens with Active Systemic Juvenile Idiopathic Arthritis

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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 is a type of arthritis that affects children and adolescents. The study will explore the effects of two treatments: Upadacitinib, which is taken orally, and Tocilizumab, which is administered either through an injection or an infusion. The purpose of the study is to evaluate how these treatments affect the disease activity, observe any side effects, and understand how the drugs move through the body in young participants.

Participants in the study will receive either Upadacitinib or Tocilizumab over a period of time. The study will monitor changes in the disease’s activity and any adverse events that may occur. The study will also look at how the drugs are processed in the body. The trial is designed to provide valuable information on the safety and effectiveness of these treatments for children and adolescents with active Systemic Juvenile Idiopathic Arthritis.

The study will last for up to 52 weeks, during which participants will be regularly assessed to track their progress and any changes in their condition. This research aims to improve understanding and treatment options for young people living with Systemic Juvenile Idiopathic Arthritis.

1 joining the study

Upon joining the study, participants will be informed about the trial’s objectives and procedures. Consent will be obtained from the participant or their legally authorized representative.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes checking age, weight, and specific laboratory values such as liver enzymes and blood cell counts.

3 medication administration

Participants will receive either upadacitinib or tocilizumab as part of the study treatment.

Upadacitinib is administered orally. The specific dosage and frequency will be determined by the study protocol.

Tocilizumab can be administered as a subcutaneous injection or as an intravenous infusion. The form and dosage will depend on the participant’s specific needs and the study protocol.

4 ongoing monitoring

Participants will be monitored regularly to assess the effectiveness and safety of the treatment. This includes evaluating changes in disease activity and any adverse events.

Regular assessments will include physical examinations, laboratory tests, and questionnaires about health and disease activity.

5 evaluation of outcomes

The primary outcome will be assessed at Week 12, focusing on the improvement in disease symptoms and absence of fever.

Secondary outcomes will also be evaluated, including further improvements in disease symptoms and overall health assessments.

6 completion of the study

The study is expected to continue until February 2029. Participants will complete the study after the final assessments are conducted.

Who Can Join the Study?

The child or their legal guardian must understand and agree to follow all study requirements. They must sign a consent form before any study activities begin.
The child must be between 1 and less than 18 years old. In some countries, if a specific medication is not approved, the child must be between 2 and less than 18 years old.
The child must weigh at least 10 kilograms at the start of the study.
The child must have certain blood test results within normal limits before starting the study. These include:
- Levels of liver enzymes called AST and ALT must be less than 2 times the normal limit for their age and sex.
- The estimated glomerular filtration rate (eGFR), which measures kidney function, must be at least 60 mL/min/1.73 m² for children under 12, and at least 60 mL/min for those 12 and older.
- The total white blood cell count (WBC) must be at least 3,000 per microliter.
- The absolute neutrophil count (ANC), a type of white blood cell, must be at least 2,000 per microliter.
- The platelet count, which helps with blood clotting, must be at least 100,000 per microliter.
- The absolute lymphocyte count (ALC), another type of white blood cell, must be at least 750 per microliter.
- The hemoglobin level, which carries oxygen in the blood, must be at least 9 grams per deciliter.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could affect their participation in the study.
Patients who are currently taking medications that might interfere with the study treatment.
Patients who have had a recent infection or illness that could impact their health during the study.
Patients who have a history of allergic reactions to the study medications.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a history of substance abuse or addiction.
Patients who have a condition that affects their immune system, making them more prone to infections.
Patients who have been diagnosed with cancer or have had cancer in the past.
Patients who have a history of heart problems or other serious heart conditions.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH	Feldkirch	Austria
St.-Josef-Stift	Sendenhorst	Germany
Semmelweis University	Budapest	Hungary
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Asklepios Klinik Sankt Augustin GmbH	Sankt Augustin	Germany
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
ZNA Jan Palfijn	Antwerp	Belgium
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Hamburger Zentrum für Kinder- und Jugendrheumatologie	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	06.12.2023
Belgium	Not recruiting	06.12.2023
Germany	Recruiting	06.12.2023
Hungary	Recruiting	06.12.2023
Italy	Recruiting	06.12.2023
Spain	Recruiting	06.12.2023
Sweden	Recruiting	06.12.2023
The Netherlands	Recruiting	06.12.2023

Trial locations

Investigated drugs:

Upadacitinib is a medication being studied for its effectiveness and safety in treating children and adolescents with active systemic juvenile idiopathic arthritis (sJIA). It works by targeting specific pathways in the immune system that are involved in inflammation, potentially reducing symptoms such as joint pain and swelling.

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 protein in the body that causes inflammation. This medication is being used to compare the effects of upadacitinib in the trial.

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 swelling, pain, 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 of juvenile idiopathic arthritis is unknown, but it is believed to involve a combination of genetic and environmental factors. The progression of the disease can vary greatly, with some children experiencing symptoms for only a few months, while others may have symptoms for many years.

Trial ID:

2022-501599-25-00

Protocol code:

M14-682

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Upadacitinib and Tocilizumab for Children and Teens with Active Systemic Juvenile Idiopathic Arthritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?