RecruitingPHASE3INTERVENTIONAL

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

This important study, called SMART-JIA, is for children aged 2 to 17 who have a type of arthritis called polyarticular juvenile idiopathic arthritis (JIA). These children have already tried an anti-TNF medicine (TNFi) but it hasn't fully controlled their symptoms. The study aims to find the best next medicine to try. Researchers will compare a second anti-TNF medicine against three other well-known arthritis medicines (Abatacept, Tocilizumab, and Tofacitinib). The goal is to discover the best way to choose medicines in a sequence, rather than through trial and error, to help children with JIA feel better sooner and improve their long-term health.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Duke University

Enrolment target

400

Start

09 Jan 2026

Estimated completion

01 Dec 2026

Polyarticular Course Juvenile Idiopathic Arthritis (JIA)

What is this study about?

This study, called SMART-JIA, is designed to help children and young people aged 2 to 17 who have a type of arthritis called polyarticular juvenile idiopathic arthritis (JIA). This is a condition where a child's joints become inflamed, causing pain, swelling, and stiffness. Many children with JIA start treatment with a medicine called a TNF inhibitor (TNFi). However, for some, this first medicine doesn't work as well as hoped.

The main idea behind this study is to find the best 'second step' medicine for these children. Instead of guessing which medicine might work next, the researchers want to compare several established treatments directly. They will be looking at a second TNFi medicine and three other different types of medicines (Abatacept, Tocilizumab, and Tofacitinib), all of which are already approved and used for JIA. The study is set up to see which of these options works best when a child needs to switch their treatment.

What makes this study special is its 'smart' design. This means if a child doesn't respond well to the first study medicine they are given, they might have the chance to try a different medicine within the study. This approach helps researchers understand not just which single medicine is best, but also the best order or 'sequence' of medicines to try. The aim is to move away from a 'trial and error' approach and instead give doctors clear information to choose the most effective treatment for each child, helping them manage their arthritis better and faster.

Key takeaways

A study for children aged 2-17 with JIA that hasn't fully responded to their first medicine.
Compares different existing JIA treatments to find the best next steps.
Aims to improve how doctors choose medicines for children with JIA.
All medicines in the study are currently approved and used for JIA.
Involves regular clinic visits, check-ups, and blood tests.

Who may be eligible?

To be considered for this study, children must be between 2 and 17 years old and weigh at least 10kg. They need to have polyarticular JIA, a specific type of childhood arthritis, and their arthritis must still be quite active despite having taken their first TNF inhibitor medicine for at least three months. If they are taking steroids, the dose needs to be stable and not too high.

There are also some reasons why a child might not be able to join. For example, if they have other specific types of JIA (like systemic JIA), or if they have certain other health conditions like active inflammatory bowel disease, active psoriasis, active eye inflammation (uveitis), or have had certain cancers. Children who have already tried more than one TNF inhibitor, or other types of advanced arthritis medicines, also wouldn't be able to participate.

Finally, children will need to have certain blood test results within a healthy range and must not have active infections, especially tuberculosis. Parents or guardians will need to give their full permission for their child 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.

Is your child aged between 2 and 17 years old?
Does your child have polyarticular JIA?
Has your child tried a first TNF inhibitor medicine for at least 3 months, but their JIA is still active?
Does your child have generally good overall health, without certain serious infections or other specific health conditions?
Are you able to provide informed consent for your child to participate?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, the doctors and nurses will explain everything in detail. Your child will be given one of the study medicines, which are all existing treatments for JIA. Some medicines are given as an injection under the skin (weekly, every other week, or every three weeks), and one is a tablet taken twice a day.

Your child will have regular visits to the clinic for assessments. These will include check-ups, physical examinations, and blood tests to monitor their arthritis and overall health. If your child doesn't respond well to the first study medicine they receive, the study design allows for a possible change to a different study medicine later on. The total length of time your child will be involved in the study will be discussed with you.

Potential risks and benefits

Taking part in a study like this can have potential benefits. Your child will receive close monitoring and access to established JIA treatments, with the potential to find a more effective medicine for their arthritis. The study also helps future children with JIA by improving understanding of the best treatment approaches. Like all medicines and medical procedures, there are potential risks, including side effects from the medications. These will be fully explained by the study team. You and your child have the right to withdraw from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (6)

University of California San Francisco Pediatric Rheumatology
Verified postcode
San Francisco, United States· Recruiting
University of Florida
Verified postcode
Gainesville, United States· Recruiting
Hackensack Meridian Health - Joseph M. Sanzari Children's Hospital
Verified postcode
Hackensack, United States· Recruiting
Nationwide Children's Hospital
Verified postcode
Columbus, United States· Recruiting
Asklepios Children's Hospital
Verified postcode
Sankt Augustin, Germany· Recruiting
IRCCS Giannina Gaslini Institute
Verified postcode
Genoa, Italy· Recruiting

Common questions

What is polyarticular Juvenile Idiopathic Arthritis (JIA)?

It's a type of childhood arthritis where several joints are affected, causing pain, swelling, and stiffness.

What is a TNF inhibitor (TNFi)?

It's a type of medicine often used for JIA that helps reduce inflammation in the body.

Are the medicines used in this study new or experimental?

No, all the medicines being compared in this study are already approved and regularly used to treat JIA.

Will my child automatically get the best medicine?

Participants are randomly assigned to one of the study medicines. The goal is to discover which medicine or sequence of medicines works best overall.

How long will my child need to be in the study?

The study team will explain the expected duration of participation during your initial discussions.

How to find out more

Laura E Schanberg (Contact PI)

laura.schanberg@duke.edu 919-373-3863 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.