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Study on Early Drug Withdrawal in Children with Juvenile Idiopathic Arthritis Using Secukinumab and Drug Combination for Those in Clinical Remission

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on children with juvenile idiopathic arthritis, a type of arthritis that affects children and causes joint inflammation and stiffness. The study aims to explore the effects of withdrawing medications early in children who have been in clinical remission, meaning their disease is inactive, for at least six months. The medications being studied include Cosentyx (secukinumab), Olumiant (baricitinib), Reumaflex (methotrexate), Enbrel (etanercept), RoActemra (tocilizumab), XELJANZ (tofacitinib), Simponi (golimumab), and ORENCIA (abatacept). Some participants will continue their medication as usual, while others will stop taking it earlier, guided by specific tests and imaging results.

The purpose of the study is to determine if stopping medication early, based on certain health markers, is safe and more effective than the standard practice of maintaining the same treatment for a longer period. Participants will be randomly assigned to either continue their medication or to stop it early. Throughout the study, the health of the participants will be closely monitored to see if their arthritis symptoms return, which is known as a flare-up. The study will compare the number of flare-ups and the time it takes for them to occur between the two groups.

This trial is designed to help understand if early withdrawal of medication can be a safe and effective option for children with juvenile idiopathic arthritis who are in remission. The study will use advanced techniques like imaging and multi-Omics, which involves analyzing various biological data, to guide the decision on when to stop the medication. The findings could lead to more personalized treatment plans for children with this condition.

The research process

The trial runs in 4 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, you will be randomly assigned to one of two groups. One group will stop taking their medication early, guided by specific health markers, while the other group will continue their medication for a longer period.
This study focuses on children with juvenile idiopathic arthritis who have been in a state of inactive disease for at least six months while on medication.
Step 2
Medication administration
Depending on your assigned group, you may continue taking your current medication or begin a process of reducing it. The medications involved in the study include secukinumab, baricitinib, methotrexate, etanercept, tocilizumab, tofacitinib, golimumab, adalimumab, and abatacept.
These medications are administered in various forms such as injections under the skin, oral tablets, or intravenous infusions. The specific medication, dosage, and frequency will depend on your current treatment plan and the study protocol.
Step 3
Monitoring and assessments
Throughout the study, regular health assessments will be conducted to monitor your condition. This includes checking for any signs of disease flare-ups and evaluating your overall health status.
These assessments may involve physical examinations, blood tests, and imaging studies to ensure that the treatment plan is effective and safe.
Step 4
End of study participation
The study is expected to continue until September 2026. Your participation will involve regular follow-ups and assessments until the study concludes or until you complete your assigned treatment plan.
At the end of the study, a final assessment will be conducted to evaluate the outcomes of the treatment strategy you followed.

Who can join the trial?

6 criteria

Children diagnosed with Juvenile Idiopathic Arthritis (JIA) according to specific medical classifications, including Oligoarthritis, Rheumatoid factor negative polyarthritis, Rheumatoid factor positive polyarthritis, Psoriatic arthritis, and Enthesitis-related arthritis.
JIA patients who have had inactive disease for at least 6 continuous months while still taking medication. Inactive disease means that the symptoms of arthritis are not currently active.
JIA patients who are taking specific types of medications known as cs/b/bs/tsDMARDs, which are drugs used to treat arthritis, according to the recommended guidelines.
Ability to follow all study procedures and communicate effectively with the study staff. This also includes the ability to provide written informed consent, which is a document that explains the study and confirms the participant's willingness to join. This requirement applies to both the parents and the patients, as needed.
Written informed consent must be obtained from the patient's parents or legal guardian.
Females who can have children must have a negative pregnancy test at the start of the trial. If they are sexually active, they must not plan to become pregnant while taking antirheumatic drugs during the study.

Who cannot join the trial?

2 criteria

Patients who have not achieved 6 months of clinical inactive disease (CID) with medication. This means the disease should not show any active symptoms for at least 6 months while on medication.
Patients who have subclinical inflammation. This refers to inflammation that is not visible through symptoms but can be detected through medical tests.

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Verified sites

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

Verified
A.O.U. Policlinico G. Martino Di Messina
Messina, Italy
Responsive
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate
Chieti, Italy
Responsive
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Vilnius, Lithuania

Trial locations

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Investigated drugs

Antirheumatic Agents are medications used to treat juvenile idiopathic arthritis (JIA) by reducing inflammation and pain in the joints. In this clinical trial, these medications are being studied to see if they can be safely stopped early in children who have been in remission, meaning their disease is not active, for six months. The goal is to find out if stopping the medication early, based on certain health markers, is as safe and effective as continuing the medication for a longer period.

Tofacitinib

What is already known about the treatment

Antirheumatic agents – These medications are typically administered orally or through injections to help manage juvenile idiopathic arthritis, a condition causing joint inflammation in children. Currently, these agents are well-established in medical practice and literature for their role in reducing inflammation and pain. They work by targeting specific pathways in the immune system to decrease the activity that leads to joint damage. Antirheumatic agents are classified under disease-modifying antirheumatic drugs (DMARDs), which are known for their ability to slow down the progression of arthritis.

Investigated diseases

Juvenile idiopathic arthritis – Juvenile idiopathic arthritis 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, the inflammation can lead to joint damage and affect growth and development. The progression of the disease varies, with some children experiencing periods of remission and others having persistent symptoms. The exact cause of juvenile idiopathic arthritis is unknown, but it is believed to involve a combination of genetic and environmental factors.