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Study on Treatment Strategies for Children and Adolescents with Juvenile Idiopathic Arthritis Using Methotrexate and Drug Combination

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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 Juvenile Idiopathic Arthritis, a condition that causes joint inflammation in children and adolescents. The trial will explore different treatment strategies for those who have been in a stable, inactive state of the disease. The treatments being studied include Methotrexate, which can be taken as an oral solution, tablets, or as a solution for injection, and tumor necrosis factor inhibitors (TNFi) such as Golimumab, Adalimumab, and Etanercept, all of which are administered as injections.

The purpose of the study is to compare the effects of continuing stable treatment with Methotrexate and TNFi against two different strategies for withdrawing these treatments. The study aims to understand how these strategies affect the risk of disease flares, which are periods when symptoms worsen. Participants will be monitored over a period of time to see if they experience any flares and how quickly they can return to an inactive state of the disease after a flare.

Throughout the study, researchers will also track changes in disease activity and any side effects or unexpected reactions to the treatments. The study will last for several years, with participants being followed up for at least 12 months to gather comprehensive data on the effectiveness and safety of the treatment strategies. This research aims to optimize treatment plans for young patients with Juvenile Idiopathic Arthritis who are in sustained remission.

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 and meets the criteria for participation, including being in sustained remission for at least 12 months.
Step 2
Initial treatment phase
The patient continues with a stable treatment regimen that includes methotrexate and a tumor necrosis factor inhibitor (TNFi). Methotrexate is administered orally, while TNFi options such as golimumab, adalimumab, or etanercept are administered subcutaneously.
Step 3
Randomization and treatment strategy
The patient is randomly assigned to one of three treatment strategies: continued stable treatment, gradual withdrawal of methotrexate, or gradual withdrawal of TNFi. The goal is to assess the effect of these strategies on the risk of disease flare.
Step 4
Monitoring and follow-up
The patient is monitored for a period of 12 months to observe any disease flare-ups. A flare is defined by an increase in disease activity or a consensus between the physician and the patient that a significant flare has occurred.
Step 5
Assessment of outcomes
The primary outcome is the proportion of patients experiencing a disease flare during the 12-month follow-up. Secondary outcomes include the time to flare, time to regain inactive disease, changes in disease activity measures, and reports of adverse events.

Who can join the trial?

9 criteria

The patient must have a condition called Juvenile Idiopathic Arthritis, which is a type of arthritis that affects children.
The patient should be between 2 and 18 years old at the time of signing the consent form.
The patient must meet the ILAR classification criteria for non-systemic JIA. This is a set of guidelines used by doctors to diagnose this type of arthritis.
The patient should have had sustained clinical remission for at least 12 months. This means the disease has been inactive, as judged by a doctor, for at least a year.
The patient must have had at least two doctor visits in the last 18 months that confirm the disease is inactive.
The patient should have Wallace inactive disease at the time of joining the study. This is a specific way doctors measure if the disease is inactive.
The patient must not have had any active uveitis for at least 24 months. Uveitis is an inflammation of the eye.
The patient should have been on a stable treatment with a TNF-inhibitor and methotrexate for at least 3 months. These are medications used to treat the condition.
Both male and female patients can participate.

Who cannot join the trial?

10 criteria

Patients who do not have a diagnosis of Juvenile Idiopathic Arthritis. This is a type of arthritis that occurs in children.
Patients who have not had sustained inactive disease for at least 12 months. This means their disease has not been inactive or stable for a year.
Patients who are not between the ages of 2 and 18 years old.
Patients who are not able to follow the study procedures or take the study medications as required.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection or illness that could affect the study results.
Patients who have a history of severe allergic reactions to any of the study medications.
Patients who have not been judged by their doctor to have inactive disease at the time of joining the study.

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Verified sites

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

Verified
Helse Bergen HF
Bergen, Norway
Verified
Helse Stavanger HF
Stavanger, Norway
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

Trial locations

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Investigated drugs

Methotrexate
is a medication used to treat juvenile idiopathic arthritis by reducing inflammation and slowing down the disease's progression. In this trial, it is used as a stable treatment option to compare against other strategies.
Tumor Necrosis Factor Inhibitor (TNFi)
is a type of medication that helps control inflammation by blocking a protein called tumor necrosis factor, which is involved in causing inflammation in the body. In this trial, it is used alongside methotrexate as a stable treatment option for comparison.

What is already known about the treatment

Methotrexate
Methotrexate is typically administered orally or by injection and is used to treat various conditions, including juvenile idiopathic arthritis. It is well-established in medical literature as a disease-modifying antirheumatic drug (DMARD). Methotrexate works by inhibiting the enzyme dihydrofolate reductase, which plays a role in DNA synthesis, thus reducing inflammation and slowing disease progression. It is classified as an antimetabolite and immunosuppressant.
Tumor Necrosis Factor Inhibitor (TNFi)
TNFi medications are usually given by injection and are used to manage autoimmune conditions like juvenile idiopathic arthritis. These drugs are recognized in medical literature for their ability to block tumor necrosis factor, a substance in the body that causes inflammation. By inhibiting this factor, TNFi medications help reduce inflammation and prevent joint damage. They are classified as biologic response modifiers.

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 progression of the disease can vary, with periods of remission and flare-ups. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors.