AuthorisedTherapeutic confirmatory (Phase III)Interventional

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis (SMART-JIA)

This study, called SMART-JIA, is for children and young people who have Juvenile Idiopathic Arthritis (JIA). This is a type of arthritis that affects children. The study is for those whose current medication (a 'TNFi' medicine) has not fully controlled their JIA. We are comparing several different medicines, including Humira, Orencia, Tyenne, Xeljanz, and Enbrel, to see which works best. The main aim is to find out which medicine most effectively reduces the arthritis activity and helps children feel better after 6 months. We will also check pain, tiredness, and how easily they can move around, both at 6 months and again at 12 months.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Duke Clinical Research Institute

Enrolment target

Start

10 Feb 2026

Juvenile Idiopathic Arthritis

What is this study about?

This study is called SMART-JIA, which stands for Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis. It's for children and young people who have Juvenile Idiopathic Arthritis (JIA), a long-term condition that causes painful and stiff joints. Sometimes, the first type of medicine used, called a TNFi, doesn't work as well as doctors and patients hope.

The main goal of this study is to find out which of several other medicines works best when a TNFi medicine hasn't been effective enough. We want to see which one helps to control the JIA symptoms most effectively, leading to less joint pain and swelling. The different medicines being looked at include Humira, Orencia, Tyenne, Xeljanz, and Enbrel. These are all approved treatments for JIA, and the study helps doctors understand the best way to use them.

By comparing these medicines, we hope to find clearer guidance for doctors on how to treat children and young people with JIA who haven't responded well to their initial treatment. This could ultimately lead to better health outcomes and an improved quality of life for many young people living with JIA.

Key takeaways

The study is for children and young people with JIA whose current treatment isn't working well enough.
It compares different established medicines to find out which one works best.
The main aim is to improve JIA symptoms like pain, tiredness, and movement.
Participation involves regular clinic visits and receiving study medication.
You can stop participating at any time if you wish.

Who may be eligible?

Anyone, regardless of their age or gender, could potentially be considered for this study as long as they have Juvenile Idiopathic Arthritis (JIA).

However, it's specifically for those whose JIA hasn't been fully controlled by a type of medicine called a 'TNFi'. This means you would have tried one of those medicines already, and your arthritis symptoms haven't improved as much as hoped.

Before joining, doctors will carefully check your medical history and current health to make sure the study is a good fit for you and that it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have been diagnosed with Juvenile Idiopathic Arthritis (JIA).
I have tried a specific type of JIA medicine (a 'TNFi') already.
My current JIA treatment (TNFi) hasn't fully controlled my arthritis.
I am open to trying a new medicine under careful medical supervision.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive one of the study medicines, which are given either as an injection or as tablets. You would have regular visits to the hospital or clinic over a period of time, where doctors and nurses would check how you're feeling and how your JIA is responding to the treatment. These visits will involve assessments like checking your joints, asking about your pain and energy levels, and sometimes taking blood samples.

The main check on how well the medicine is working will happen after 6 months. There will also be further checks at 12 months to see how you are doing in the longer term. The total length of your participation in the study, including all follow-up, would be discussed with you by the study team.

Potential risks and benefits

Taking part in this study might offer the benefit of finding a more effective treatment for your JIA, which could lead to less pain, less tiredness, and better movement. However, like all medicines, the study treatments can have side effects, and some may not work as well for you. The study team will explain these potential risks in detail. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Netherlands
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Unverified
Germany

Common questions

What is Juvenile Idiopathic Arthritis (JIA)?

JIA is a type of arthritis that affects children and young people, causing joint pain, swelling, and stiffness.

Why is this study being done?

It's being done to find out which existing medicines work best for children with JIA when their first type of treatment hasn't fully helped.

What kind of medicines are being tested?

We are studying several established JIA medicines like Humira, Orencia, Tyenne, Xeljanz, and Enbrel, given as injections or tablets.

How long will I have to be in the study?

The main results are measured at 6 months, with further checks at 12 months. The study team will tell you the exact duration.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any time without it affecting your future medical care.