Study on Anakinra 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 autoimmune disorder affecting the joints. The treatment being investigated is a medication called anakinra, which is administered as a solution for injection. Anakinra is a type of protein that helps to block certain substances in the body that can cause inflammation and joint damage.

The purpose of this study is to explore a new strategy for using anakinra in children with sJIA. The study aims to determine if using a specific marker in the blood, called IL-18, can help guide the treatment process. This approach may help reduce the number of injections needed to keep the disease inactive during the first year of treatment. The study will involve an initial phase where patients receive anakinra, followed by a phase where the treatment is gradually reduced and stopped, depending on the patient’s response.

Throughout the study, researchers will monitor the number of injections required, the number of patients who achieve disease remission without medication, and any potential side effects. The goal is to find a more efficient way to manage sJIA, potentially reducing the treatment burden for patients while maintaining effective disease control.

1 joining the trial

Upon joining the trial, participants are required to provide consent. This involves signing forms that confirm understanding and agreement to participate in the study.

Participants must be children or adolescents diagnosed with systemic juvenile idiopathic arthritis (sJIA), aged between 8 months and 16 years.

2 initial treatment phase

Participants begin treatment with a medication called anakinra, which is administered as a subcutaneous injection. This means the medication is injected under the skin.

The dosage is 100 mg/0.67 ml of the solution, provided in a pre-filled syringe. The frequency and duration of administration are determined by the study protocol and the participant’s response to the treatment.

3 observation of initial response

Participants are monitored for an initial beneficial response to the treatment. This includes checking for the absence of fever by day 7 of treatment.

The goal is to achieve at least a 90% improvement in symptoms without fever around 90 days after starting the therapy.

4 tapering and stop phase

If the initial response is positive, the study moves into a phase where the medication is gradually reduced, known as tapering, and eventually stopped.

The decision to taper and stop the medication is guided by specific biomarkers, including IL-18, to ensure the disease remains inactive.

5 monitoring and follow-up

Throughout the trial, participants are regularly monitored to assess the number of injections needed to maintain inactive disease status.

The study also tracks any disease flares, the need for alternative treatments, and any adverse events that may occur during the first year of treatment.

6 end of trial assessment

At the end of the trial, the primary goal is to determine the average number of injections required to maintain inactive disease within the first year.

Secondary assessments include the number of participants who achieve remission without medication after one and two years, and the overall safety and effectiveness of the treatment strategy.

Who Can Join the Study?

Children and adolescents diagnosed with sJIA (systemic Juvenile Idiopathic Arthritis), which is a type of arthritis that affects children.
Both male and female patients can participate.
Patients must be aged 8 months to 16 years.
Parents or legal guardians (and the child, if old enough) must be willing to sign consent forms, which are documents that show they agree to participate in the study.
For the treatment phase, patients must have been treated with rIL-1RA (a type of medication) as their first treatment and shown an initial positive response, meaning no fever by the seventh day of treatment.
Patients must achieve at least an ACRPed90 response without fever around 90 days after starting the treatment. This means they show significant improvement in their symptoms.

Who Cannot Join the Study?

Patients with any autoimmune disorders. These are conditions where the body’s immune system attacks its own tissues.
Patients with any joint disorders. These are problems that affect the joints, which are the areas where two bones meet.
Patients diagnosed with Still’s disease or systemic JIA. These are specific types of joint disorders.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Wlpbejxznf Crqkuzhla Hlglbgis	Utrecht	The Netherlands
Uecnmoopinll Mgwpdlp Cuuskzf Gvnebpoic	Groningen	The Netherlands
Aslieohfn Urh	Amsterdam	The Netherlands
Etcaeqb Uosntlzbguzz Mmvylye Cvsejqp Rnrtlunze (ifoufyf Mtv	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.10.2016

Trial locations

Investigated drugs:

Anakinra

Anakinra is a medication used in this clinical trial. It is a type of treatment that helps to reduce inflammation in the body. Anakinra works by blocking a specific protein in the body that can cause inflammation and pain. This medication is often used for conditions like systemic Juvenile Idiopathic Arthritis, where the immune system mistakenly attacks the body’s own tissues, leading to joint pain and swelling. In this trial, the goal is to use Anakinra to achieve and maintain a state where the disease is not active, meaning the symptoms are under control. The study is also exploring whether using a specific biomarker, IL-18, can help reduce the number of Anakinra injections needed to keep the disease inactive.

Investigated diseases:

Systemic Juvenile Idiopathic Arthritis – Systemic Juvenile Idiopathic Arthritis (sJIA) 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. The disease can cause swelling, pain, and stiffness in the joints, which may lead to reduced movement. It often begins with systemic symptoms such as fever, rash, and inflammation of internal organs. Over time, the joint symptoms may become more prominent, potentially leading to joint damage. The disease can have periods of remission and flare-ups, where symptoms worsen. It is considered an autoimmune disorder, where the body’s immune system mistakenly attacks its own tissues.

Trial ID:

2024-518684-35-00

Protocol code:

NL55231.041.16

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Anakinra for Children with Systemic Juvenile Idiopathic Arthritis

What is this study about?

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