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Maintenance versus tapered TNF‑alpha inhibitor therapy (golimumab, etanercept, adalimumab) in children and adolescents with juvenile idiopathic arthritis

Verified siteRegistered drugNo placebo

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What is this trial about?

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

The trial focuses on children and adolescents with Juvenile Idiopathic Arthritis, a condition that causes joint swelling, pain and stiffness. The medicines being examined belong to a group called TNF alpha inhibitor, which works by blocking a protein that drives inflammation. In this study the specific drugs golimumab, etanercept and adalimumab are given as subcutaneous injections (injected under the skin) and are used as monotherapy, meaning only one medication is taken.

The purpose of the study is to determine whether reducing or stopping the medication after the disease has been quiet for at least a year changes the chance of a worsening episode compared with continuing the same dose.

Participants who meet the criteria will be randomly assigned to either keep the same amount of medicine (stable dose) or to slowly lower the amount and eventually stop (tapered). Over the following 12 months they will attend regular check‑ups where doctors will look for signs of a flare, which means a noticeable increase in joint pain, swelling or loss of movement, indicating the disease is no longer in an inactive disease state. If a flare occurs, treatment can be restarted to bring the condition back under control, and safety and any side effects are recorded throughout the year.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessment and enrollment
After signing the consent form, you attend a baseline visit where the study team confirms that you have had inactive disease for at least 12 months, documented at two consecutive visits.
Clinical criteria (JIA-ACR/Wallace) are used to verify inactivity before you are officially entered into the trial.
Step 2
Randomization to treatment group
You are randomly assigned to one of two groups: a maintenance group that continues the same TNF alpha inhibitor dose, or a tapered/withdrawal group in which the dose is gradually reduced or stopped according to the study protocol.
Step 3
Medication administration – maintenance group
If you remain in the maintenance group, you continue the same subcutaneous injection that you were using before enrollment.
Examples of possible medications and their doses are:
Simponi: 1.7 mg golimumab solution for injection, administered subcutaneously as instructed.
Benepali or Enbrel: 7 mg etanercept solution for injection, administered subcutaneously as instructed.
Hyrimoz: 3 mg adalimumab solution for injection (available as 20 mg or 40 mg pre‑filled syringe), administered subcutaneously as instructed.
The medication is taken for the full 12‑month follow‑up period.
Step 4
Medication administration – tapered/withdrawal group
If you are assigned to the tapered/withdrawal group, the same medication you have been using is reduced in dose or stopped according to a step‑wise schedule defined by the study protocol.
The schedule may involve decreasing the amount of the injection over several weeks before complete discontinuation.
The total time you remain on any dose of the medication does not exceed the 12‑month follow‑up period.
Step 5
Regular follow‑up visits
You attend clinic visits at predetermined intervals (for example, every 3 months) during the 12‑month study period.
At each visit the study team measures disease activity, records any adverse events, and checks safety laboratory results.
The primary tool for assessing disease activity is the JADAS‑27 score, which quantifies joint inflammation and overall disease status.
Step 6
Monitoring for disease flare
A flare is defined as an increase in the JADAS‑27 score of at least 1.7 from the baseline value together with at least one active joint (swollen, tender, or with limited range of motion).
If a flare is detected, the study protocol allows your physician to adjust treatment, which may include restarting the previous dose of the TNF inhibitor.
Step 7
Final assessment at 12 months
At the end of the 12‑month follow‑up you undergo a final evaluation that includes the JADAS‑27 score, documentation of any flares that occurred, and a review of all adverse events.
The results are used to compare the proportion of participants who experienced a flare between the maintenance and tapered/withdrawal groups.

Who can join the trial?

6 criteria

Must meet the ILAR classification criteria for non-systemic juvenile idiopathic arthritis, which are a set of guidelines doctors use to confirm this type of arthritis.
Must be at least 2 years old but younger than 18 years old when signing the consent form.
Doctors must judge the arthritis to be inactive disease for at least 12 months, and this must be recorded at two consecutive doctor visits.
At the start of the study, the patient must satisfy the JIA‑ACR/Wallace criteria for inactive disease, which are specific signs doctors look for to say the arthritis is not active.
Must not have had any active uveitis (inflammation of the eye) for at least 24 months.
Must have been taking a stable dose of a tumor necrosis factor inhibitor as the only medication (monotherapy) for at least 12 months.

Who cannot join the trial?

2 criteria

Use of corticosteroids (strong anti‑inflammatory medicines), including shots given directly into a joint (intra‑articular injections), to treat juvenile idiopathic arthritis (JIA) within the 12 months before the study begins.
Having chronic widespread pain syndrome, which means long‑lasting pain that is present in many areas of the body.

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Verified sites

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Oslo Universitetssykehus HF
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Oslo, Norway
Sørlandet sykehus Kristiansand
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Kristiansand, Norway

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Investigated drugs

Simponi
is a medication that blocks a protein called tumor necrosis factor (TNF) which can cause inflammation. In this study it is given as a subcutaneous injection to help keep the joints of children with juvenile idiopathic arthritis calm and free of disease activity.
Benepali
is another TNF‑blocking drug, delivered in a pre‑filled pen for injection under the skin. It works by reducing the inflammation that leads to joint pain and swelling, and is used in the trial to see if continuing the same dose helps prevent disease flares.
Hyrimoz
is a TNF inhibitor that is also injected under the skin. It targets the same inflammatory pathway as the other drugs, aiming to maintain inactive disease in the trial participants. The study examines whether keeping patients on this medication at a stable dose reduces the chance of a flare.
Enbrel
is a well‑known TNF‑blocking therapy given by subcutaneous injection. It helps control the immune system’s activity that can lead to joint inflammation in juvenile idiopathic arthritis, and is tested in the trial as part of the standard treatment regimen.

What is already known about the treatment

Simponi
Simponi is a liquid that is injected under the skin using a pre‑filled syringe. It is an approved medicine that blocks a protein called TNF‑alpha, which helps reduce inflammation in diseases like rheumatoid arthritis and juvenile idiopathic arthritis. It works by attaching to TNF‑alpha and stopping it from signaling immune cells to cause swelling. It belongs to the class of human monoclonal antibody TNF‑alpha inhibitors.
Benepali
Benepali comes as a ready‑to‑use pen for subcutaneous injection. This drug is approved for conditions such as rheumatoid arthritis and juvenile idiopathic arthritis and works by binding to TNF‑alpha, preventing it from triggering inflammation. Its action is similar to a “decoy” that captures the protein before it can cause damage. It is classified as a recombinant fusion protein TNF inhibitor.
Hyrimoz
Hyrimoz is supplied as a solution for injection in a pre‑filled syringe that is given under the skin. It is an approved treatment for several inflammatory diseases, including juvenile idiopathic arthritis, and belongs to the family of fully human monoclonal antibodies. The medication attaches to TNF‑alpha and blocks its ability to promote inflammation. It is classified as a TNF‑alpha inhibitor.
Enbrel
Enbrel is provided in a pre‑filled pen for subcutaneous injection. It is an approved therapy for rheumatoid arthritis, psoriasis, and juvenile idiopathic arthritis, working by acting as a “trap” for TNF‑alpha so the protein cannot cause inflammation. By capturing TNF‑alpha, it helps keep joints and skin less swollen. It is a recombinant fusion protein classified as a TNF inhibitor.

Investigated diseases

Juvenile Idiopathic Arthritis - It is a chronic joint disease that starts before age 16, causing swelling, pain, and stiffness in one or more joints. The inflammation can appear intermittently, with periods of quiet followed by flares where symptoms worsen. Over time, affected joints may become less flexible and may develop growth disturbances. Some children also experience involvement of the eyes, skin, or other organs. The disease course varies, with some children remaining inactive for years while others have frequent activity changes.