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Study on the Safety and Effectiveness of Adalimumab and Etanercept in Children with Active Juvenile Idiopathic Arthritis

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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 the treatment of Juvenile Idiopathic Arthritis (JIA), a condition that causes joint inflammation in children. The study involves two medications: Adalimumab and Etanercept. These medications are known as anti-TNF drugs, which help reduce inflammation by blocking a protein called tumor necrosis factor (TNF) that contributes to inflammation in the body. The trial will compare the original versions of these medications with their biosimilar versions. Biosimilars are medications that are very similar to the original product but are not identical, and they are often more affordable.

The purpose of the study is to evaluate the safety and effectiveness of switching between the original and biosimilar versions of these medications in children with JIA who are in clinical remission, meaning their disease activity is low or inactive. Participants in the study will be randomly assigned to receive either the original or biosimilar version of the medication. The study will last for a total of 18 months, during which the participants' health and response to the medication will be monitored closely.

Throughout the study, the main goal is to see how many children remain in clinical remission after switching between the original and biosimilar medications. This will help determine if the biosimilar versions are as effective and safe as the original medications. The study aims to provide valuable information that could help improve treatment options for children with Juvenile Idiopathic Arthritis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient is confirmed to have Juvenile Idiopathic Arthritis (JIA) and meets the criteria for participation. This includes being between the ages of 2 and 18, having moderate to high disease activity despite previous treatment, and meeting specific weight requirements for certain medications.
Step 2
Initial treatment phase
The patient begins treatment with either adalimumab or etanercept. Adalimumab is administered as a solution for injection in a pre-filled syringe, while etanercept is provided as a powder and solvent for solution for injection. The specific dosage and frequency are determined based on the patient's weight and medical condition.
Step 3
Monitoring and assessment
Throughout the study, the patient's response to the medication is closely monitored. This includes regular assessments to evaluate the effectiveness of the treatment and any potential side effects. The goal is to achieve clinical remission, defined as a state of inactive disease for at least six months.
Step 4
Switching phase
After an initial period, the patient may be switched from the original medication to a biosimilar version, or vice versa. This phase is designed to compare the safety and efficacy of the original and biosimilar medications.
Step 5
Final assessment
At the end of the study, the patient's condition is evaluated to determine the overall effectiveness of the treatment strategy. The primary endpoint is achieving clinical remission at 18 months, with a focus on comparing outcomes between those who switched medications and those who did not.

Who can join the trial?

7 criteria

Children diagnosed with Juvenile Idiopathic Arthritis (JIA) according to specific criteria, who are candidates for treatment with certain medications called anti-TNF alpha drugs (etanercept or adalimumab).
Children must have moderate to high disease activity even after taking a medication called methotrexate for at least 3 months.
Children must be between the ages of 2 and less than 18 years old at the time they join the study.
For those taking Etanercept, only children who meet specific weight requirements can join. This is because the medication comes in fixed doses. Children must weigh more than 30 kg and less than 32 kg, or more than 62 kg.
Children and their parents must be able to follow all the study procedures and communicate effectively with the study staff.
Parents must provide written consent, which means they agree to let their child participate in the study after understanding all the details.
If the child is sexually active, they must agree to use highly effective birth control methods during the study.

Who cannot join the trial?

8 criteria

Patients who are not in **clinical remission**. This means their disease is not currently under control or showing no symptoms.
Patients who are not currently on **anti-TNF medication**. These are specific drugs used to reduce inflammation in conditions like arthritis.
Patients who have not been previously treated with **adalimumab** or **etanercept**. These are specific medications used to treat arthritis.
Patients who have any other medical conditions that might interfere with the study or the treatment.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of allergic reactions to the study medications.
Patients who are pregnant or breastfeeding.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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A.O.U. Policlinico G. Martino Di Messina
Messina, Italy
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Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
Milan, Italy
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Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy

Trial locations

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Investigated drugs

Adalimumab
is a medication used to reduce inflammation in the body. It is commonly used to treat conditions like Juvenile Idiopathic Arthritis (JIA) by blocking a protein called TNF-alpha, which is involved in inflammatory processes. In this trial, the effectiveness and safety of switching from the original adalimumab to its biosimilar version, and vice versa, are being evaluated.
Etanercept
is another medication that helps manage inflammation by targeting the TNF-alpha protein. It is used to treat autoimmune conditions such as Juvenile Idiopathic Arthritis. The trial is assessing the safety and efficacy of switching between the original etanercept and its biosimilar counterpart in children who are in clinical remission from JIA.

What is already known about the treatment

Adalimumab
Adalimumab is administered via subcutaneous injection and is used to treat conditions like Juvenile Idiopathic Arthritis. It is a well-established medication in medical literature, often used for its anti-inflammatory properties. The drug works by blocking a protein called tumor necrosis factor-alpha (TNF-alpha), which plays a role in inflammation. Adalimumab is classified as a TNF inhibitor, helping to reduce inflammation and improve symptoms in patients.
Etanercept
Etanercept is also administered through subcutaneous injection and is used to manage Juvenile Idiopathic Arthritis among other inflammatory conditions. It is widely recognized in medical literature for its effectiveness in reducing inflammation. The medication functions by inhibiting TNF-alpha, a substance in the body that causes inflammation. Etanercept is categorized as a TNF inhibitor, aiding in the reduction of inflammation and alleviation of symptoms in affected individuals.

Investigated diseases

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