Study of abatacept, tocilizumab, and tofacitinib compared to a second TNF inhibitor for children with juvenile idiopathic arthritis who did not respond to TNF inhibitor treatment

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What is this study about?

This study is looking at Juvenile Idiopathic Arthritis, which is a long-lasting condition that causes joint inflammation, pain, and swelling in children and young people. The study focuses on patients whose disease has not responded well enough to an earlier treatment with a type of medicine called TNFi. The study will compare different medications to see which works better when the first TNFi treatment has not been successful. The medications being tested include abatacept, tocilizumab, tofacitinib, adalimumab, and etanercept. Some of these medications are given as injections under the skin, while tofacitinib can be taken by mouth as tablets or liquid solution. The study will compare three types of non-TNFi medications with a second TNFi medication to see which approach is more effective at controlling the disease.

The purpose of the study is to find out which treatment is better at helping children with this type of arthritis reach a state of minimal disease activity after six months, meaning their symptoms are much improved and under better control. The study will look at whether children taking one of the three non-TNFi medications do better than those taking a second TNFi medication. The study will also measure how the different treatments affect pain, tiredness, and the ability to move around, as well as overall disease activity.

Children taking part in the study will be assigned to receive one of the four treatment approaches and will continue treatment for twelve months. During this time, they will have regular check-ups to see how well the medication is working and to monitor for any side effects. The study will measure disease activity at six months and again at twelve months to see how well each treatment controls the arthritis over time. Children in the study must be at least two years old but under eighteen years old, weigh at least ten kilograms, and have active arthritis despite having tried a TNFi medication for at least three months.

1 Treatment assignment and medication start

At the beginning of the study, the treatment will be assigned. This study compares four different medication options for joint inflammation.

The assigned treatment will be one of the following: abatacept, tocilizumab, etanercept, tofacitinib, adalimumab, or a second medication from the group called TNFi (a type of medicine that blocks a protein causing inflammation).

The medication will be administered either as an injection under the skin (subcutaneous injection) or as a tablet or liquid taken by mouth, depending on which medication is assigned.

Specific products may include pre-filled syringes with solutions for injection (such as Orencia, Tyenne, Enbrel, or Humira) or oral forms (such as Xeljanz tablets or liquid solution).

The treatment will begin after the baseline visit, and the medication dosage will be determined based on body weight and the specific product assigned.

2 Ongoing treatment period

The assigned medication will be continued regularly according to the prescribed schedule.

If the medication is an injection, it will be administered under the skin at intervals specified by the treatment protocol.

If the medication is oral (tablets or liquid), it will be taken by mouth daily as directed.

During this period, disease activity will be monitored using a measurement called cJADAS10, which assesses joint inflammation and overall disease severity.

If currently taking systemic glucocorticoids (steroid medications taken by mouth or injection that affect the whole body), the dose must remain stable at no more than 0.2 mg per kilogram of body weight per day (with a maximum of 10 mg per day).

3 Month 6 assessment

At 6 months after starting the assigned treatment, disease activity will be evaluated.

The main assessment will determine if minimal disease activity has been achieved, defined as a cJADAS10 score of 5 or less. This means the joint inflammation and disease symptoms are at a very low level.

Additional assessments will measure pain interference (how much pain affects daily activities), fatigue (tiredness), and mobility (ability to move).

Changes in disease activity will be compared to the starting point, including a measure called ACR 70, which indicates at least 70 percent improvement in arthritis symptoms.

4 Continued treatment and follow-up

After the 6-month assessment, the assigned treatment will continue.

Regular monitoring of disease activity and symptoms will continue throughout the study period.

5 Month 12 assessment

At 12 months after starting the assigned treatment, another evaluation of disease activity will be conducted.

The cJADAS10 score will be measured again to assess changes in joint inflammation and overall disease severity compared to the starting point.

Who Can Join the Study?

You must have Polyarticular course JIA, which means a type of Juvenile Idiopathic Arthritis that affects multiple joints in the body
You must have moderate or high disease activity, meaning your condition is still quite active with a score called cJADAS10 higher than 5, even after receiving treatment with a medication called a TNFi (a type of medicine that blocks inflammation) for at least 3 months
You must be at least 2 years old but younger than 18 years old, and weigh at least 10 kilograms
You must either not be taking systemic glucocorticoids (steroid medicines that affect the whole body), or if you are taking them, the dose must be stable at no more than 0.2 milligrams per kilogram of body weight per day (with a maximum of 10 milligrams per day) for at least 2 weeks before starting the study
Your parent, caregiver, or you (depending on your age) must provide written permission showing you understand and agree to participate in the study
If you are a female who is able to become pregnant, you must agree to use required birth control methods during the study or confirm that you are not sexually active

Who Cannot Join the Study?

The study has not provided specific exclusion criteria in the available information
If you are interested in this study for Juvenile Idiopathic Arthritis (a type of joint inflammation that occurs in children and causes pain, swelling, and stiffness in the joints), you should discuss with your doctor whether you meet the general requirements for participation
This study is designed for children who have a form of arthritis affecting multiple joints called polyarticular course juvenile idiopathic arthritis, and whose condition has not responded well to a previous treatment with TNFi medications (a type of medicine that blocks a substance in the body that causes inflammation)
Your doctor will need to evaluate whether there are any medical reasons why you should not participate in this study

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Asklepios Klinik Sankt Augustin GmbH	Sankt Augustin	Germany
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	05.01.2026
Italy	Not yet recruiting	05.01.2026
The Netherlands	Not yet recruiting	05.01.2026

Trial locations

Investigated drugs:

TNFi medications are a type of medicine that blocks a protein in the body called tumor necrosis factor, which causes inflammation in the joints. In this trial, some children will receive a second TNFi medication after their first one did not work well enough to control their arthritis symptoms.

Non-TNFi medications are different types of medicines that work in other ways to reduce joint inflammation and arthritis symptoms, but they do not block tumor necrosis factor. In this trial, three different non-TNFi medications will be tested to see if they work better than switching to a second TNFi medication for children whose first TNFi treatment did not control their arthritis.

Investigated diseases:

Juvenile idiopathic arthritis

Juvenile Idiopathic Arthritis – Juvenile Idiopathic Arthritis is a chronic condition that causes joint inflammation in children under the age of 16. The disease leads to pain, swelling, and stiffness in one or more joints that lasts for at least six weeks. It can affect children’s ability to move normally and participate in everyday activities. The inflammation may come and go, or it can be continuous over time. In some cases, the condition affects multiple joints throughout the body, which is called polyarticular course. The disease can also cause fatigue and may impact a child’s growth and development.

Trial ID:

2025-520923-25-00

Protocol code:

SMART-JIA

NCT ID:

NCT06654882

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of abatacept, tocilizumab, and tofacitinib compared to a second TNF inhibitor for children with juvenile idiopathic arthritis who did not respond to TNF inhibitor treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?