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Limit-JIA Clinical Trial

Treating JIA to Slow its Spread

What is Limited JIA?

JIA can be very difficult to diagnose. No one test can confirm the diagnosis, so doctors need to use a few tests and a physical exam to rule out any other reasons for a child’s joint pain. So what does having JIA look like and how will it affect your child?

The word “arthritis” means inflammation (swelling) and stiffness of the joints. Arthritis that affects children under the age of 16 is known as juvenile idiopathic arthritis, or JIA. Oligoarticular JIA (also known as limited JIA) is the most common type of JIA. It affects four or fewer joints during the first six months. After the first six months, some patients may have more than four joints affected; this is called extended oligoarticular JIA.

Over time, patients with limited JIA notice that their joints are more affected by arthritis. Patients will experience pain, swelling, stiffness, and possibly even damage to the joint bones and cartilage. Over time, certain joints may need to be replaced.

JIA can also affect a patient’s eyes, so children need to visit an eye doctor right after they are diagnosed and often after that to make sure they do not have eye disease connected to their arthritis. Thankfully, after the long process of getting a diagnosis, you can begin treating JIA right away to slow or pause its progression (spreading).

There are many effective treatments that can allow your child to live a happy and healthy life, and in his or her lifetime, your child will try many of them. Medication for arthritis in children has improved a lot in recent years, and research is helping us learn more about the condition all the time.

How is Limited JIA Treated?

Because limited JIA affects only a few joints, doctors often start treatment with injections of medicine into the swollen joints. These injections can be paired with other drugs to reduce swelling, such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Anaprox, Naprosyn), which are called non-steroidal anti-inflammatory drugs.

Some medications for oligoarticular JIA are: Non-steroidal, anti-inflammatory drugs (NSAIDs), such as ibuprofen, to ease pain and lower inflammation. These are taken in tablet or liquid form. Corticosteroids, such as prednisone, can lower swelling. These can be given as tablets, liquid, injection into the joint, or drops into the eye. Disease-modifying, anti-rheumatic drugs (DMARDs), such as methotrexate, may stop arthritis from spreading and can be taken in tablet form, liquid form, or by injection.

These are some of the most common treatments for oligoarticular JIA, meaning they are usual care. Even with usual care, JIA can still spread and get worse. About half of all oligoarticular JIA patients will experience disease spreading to more joints, uveitis (inflammation of the eyes), or both. Researchers working with parents are exploring options which may be more effective at preventing the disease from spreading than usual care.

The Limit-JIA Clinical Trial is using abatacept (Orencia™), a biologic disease-modifying, anti-rheumatic drug used to treat JIA when it starts affecting joints. In this case, we believe using abatacept earlier in treatment will prevent JIA from spreading.

How is Limited JIA Treated?

Because limited JIA affects only a few joints, doctors often start treatment with injections of medicine into the swollen joints. These injections can be paired with other drugs to reduce swelling, such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Anaprox, Naprosyn), which are called non-steroidal anti-inflammatory drugs.

Some medications for oligoarticular JIA are: Non-steroidal, anti-inflammatory drugs (NSAIDs), such as ibuprofen, to ease pain and lower inflammation. These are taken in tablet or liquid form. Corticosteroids, such as prednisone, can lower swelling. These can be given as tablets, liquid, injection into the joint, or drops into the eye. Disease-modifying, anti-rheumatic drugs (DMARDs), such as methotrexate, may stop arthritis from spreading and can be taken in tablet form, liquid form, or by injection.

These are some of the most common treatments for oligoarticular JIA, meaning they are usual care. Even with usual care, JIA can still spread and get worse. About half of all oligoarticular JIA patients will experience disease spreading to more joints, uveitis (inflammation of the eyes), or both. Researchers working with parents are exploring options which may be more effective at preventing the disease from spreading than usual care.

The Limit-JIA Clinical Trial is using abatacept (Orencia™), a biologic disease-modifying, anti-rheumatic drug used to treat JIA when it starts affecting joints. In this case, we believe using abatacept earlier in treatment will prevent JIA from spreading.

Support Resources & Video Testimonials

PREPARING FOR INJECTIONS
Kid’s Perspective
THE DIAGNOSIS JOURNEY
Kerry’s Perspective
ONE APPROACH TO INJECTIONS
Catherine’s Story
THINKING THROUGH INJECTIONS
Kid’s Perspective
THE DIAGNOSIS JOURNEY
Laura’s Perspective
JIA IN A FEW WORDS
Young Adult Perspective
THE DIAGNOSIS JOURNEY
Marcela’s Story
INJECTION DISTRACTION TECHNIQUES
Kid’s Perspective

What is the Limit-JIA Clinical Trial?

The Limit-JIA trial lasts a total of 12 months. During that time, your child will be given six months of weekly abatacept injections followed by six months of usual care.

The study also involves a few scheduled visits. There will be one screening visit to see if your child is a good fit for the clinical trial, one check-up visit, four scheduled appointments (three months apart), and two to four ophthalmology (eye doctor) visits (depending on the participant). There may also be additional doctor’s visits, as needed. Finally, parents will be asked to complete surveys related to their child and keep record of all medications their child takes for their JIA.

Benefits and Disadvantages

If you choose to join the study, there are pros and cons related to participation. Let’s weigh the choices.

Benefits include: Education, support, and feeling good about helping researchers; Close follow-ups from the care staff; Access to treatment not available to others; Treatment provided at no cost; A chance to help other patients with JIA.

Disadvantages include: Chance of having side effects from taking the study drug abatacept; Chance the drug will not work; Taking additional time for activities like surveys, etc.

Discussion Guide

To learn more about the study, you can talk to study coordinators (people who help patients before and during the clinical trial. Here are some questions you may want to ask the coordinator. More questions—and answers!—can be found in the Frequently Asked Questions section.


How long is the trial?
How often do I have to visit the study site (doctor’s office)?
How long will each visit take?
What else do I have to do while in the study?
What are the short-term side effects of abatacept?
What are the long-term side effects of abatacept?
Are there other treatments for my child’s condition?
Will the lab tests cost me anything?
Will I get the results of the tests?
Will I get any money for joining the clinical trial?
Will I get the study drug once the trial is over?
What if I have a problem with how I am treated during the clinical trial?

What is Uveitis?

In addition to joint inflammation (arthritis), eye inflammation (called uveitis) can develop in children with JIA. If not treated, uveitis can cause vision loss or blindness. Children with uveitis often do not have symptoms, such as pain, redness, or trouble seeing, so regular eye exams by a pediatric eye doctor (ophthalmologist) are necessary.

Eye Exams

The eye doctor will use special equipment to magnify the structures in the eye to see if there is inflammation or damage. The eye doctor will perform a “slit-lamp” exam—a painless test where a green light is shined through a microscope to examine the inside of the eye. If there is inflammation, the doctor will report the number of cells that they see. The number of cells indicates the amount of eye inflammation present. Sometimes eye drops are used to enlarge the eye to make it easier to see inside.

How Often

Children with oligoarticular JIA have the highest chance of developing uveitis and need to be checked by the eye doctors most often, however uveitis happens in all forms of JIA. Depending on your child’s JIA type, age, and antinuclear antibody (ANA) status, they may need to be checked every three months. Eye exams can detect inflammation early, so that treatment can start before permanent damage and vision loss.

Treatment

If the eye doctor finds uveitis, your child will need treatment. Common treatments include prescription eye drops and medications similar to those used to treat arthritis. Your eye screening interval will be determined by your rheumatologist.

If you have concerns about your child’s eyes or vision do not wait until your next visit. Contact your eye doctor immediately.

What is the Limit-JIA Clinical Trial?

The Limit-JIA trial lasts a total of 12 months. During that time, your child will be given six months of weekly abatacept injections followed by six months of usual care.

The study also involves a few scheduled visits. There will be one screening visit to see if your child is a good fit for the clinical trial, one check-up visit, four scheduled appointments (three months apart), and two to four ophthalmology (eye doctor) visits (depending on the participant). There may also be additional doctor’s visits, as needed. Finally, parents will be asked to complete surveys related to their child and keep record of all medications their child takes for their JIA.

Benefits and Disadvantages

If you choose to join the study, there are pros and cons related to participation. Let’s weigh the choices.

Benefits include: Education, support, and feeling good about helping researchers; Close follow-ups from the care staff; Access to treatment not available to others; Treatment provided at no cost; A chance to help other patients with JIA.

Disadvantages include: Chance of having side effects from taking the study drug abatacept; Chance the drug will not work; Taking additional time for activities like surveys, etc.

Discussion Guide

To learn more about the study, you can talk to study coordinators (people who help patients before and during the clinical trial. Here are some questions you may want to ask the coordinator. More questions—and answers!—can be found in the Frequently Asked Questions section.


How long is the trial?
How often do I have to visit the study site (doctor’s office)?
How long will each visit take?
What else do I have to do while in the study?
What are the short-term side effects of abatacept?
What are the long-term side effects of abatacept?
Are there other treatments for my child’s condition?
Will the lab tests cost me anything?
Will I get the results of the tests?
Will I get any money for joining the clinical trial?
Will I get the study drug once the trial is over?
What if I have a problem with how I am treated during the clinical trial?

What is Uveitis?

In addition to joint inflammation (arthritis), eye inflammation (called uveitis) can develop in children with JIA. If not treated, uveitis can cause vision loss or blindness. Children with uveitis often do not have symptoms, such as pain, redness, or trouble seeing, so regular eye exams by a pediatric eye doctor (ophthalmologist) are necessary.

Eye Exams

The eye doctor will use special equipment to magnify the structures in the eye to see if there is inflammation or damage. The eye doctor will perform a “slit-lamp” exam—a painless test where a green light is shined through a microscope to examine the inside of the eye. If there is inflammation, the doctor will report the number of cells that they see. The number of cells indicates the amount of eye inflammation present. Sometimes eye drops are used to enlarge the eye to make it easier to see inside.

How Often

Children with oligoarticular JIA have the highest chance of developing uveitis and need to be checked by the eye doctors most often, however uveitis happens in all forms of JIA. Depending on your child’s JIA type, age, and antinuclear antibody (ANA) status, they may need to be checked every three months. Eye exams can detect inflammation early, so that treatment can start before permanent damage and vision loss.

Treatment

If the eye doctor finds uveitis, your child will need treatment. Common treatments include prescription eye drops and medications similar to those used to treat arthritis. Your eye screening interval will be determined by your rheumatologist.

If you have concerns about your child’s eyes or vision do not wait until your next visit. Contact your eye doctor immediately.

Frequently Asked Questions

Why are we doing the Limit-JIA clinical trial?

Treatment for JIA has come a long way in the last 20 years, with many medications available now to slow or stop the disease. But, usual care of oligoarticular JIA still results in JIA getting worse for about half the children. After JIA gets worse by spreading to more joints or the eyes, children are given a medication like abatacept (Orencia). We want to learn if we can prevent JIA from getting worse by using abatacept (Orencia) as soon as they are diagnosed with oligoarticular JIA.

What is a clinical trial?

A clinical trial is designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. In Limit-JIA, our question is, “Can we prevent oligoarticular JIA from getting worse by using abatacept (Orencia™) in the beginning?”

Why is abatacept (Orencia™) being used in this clinical trial?

Abatacept (Orencia™) is approved by the Food and Drug Administration (FDA) to treat moderate to severe JIA. We are testing to see if using it earlier (or, shortly following diagnosis) can help prevent JIA from getting worse, which happens to about half the children who receive usual care.

What other drugs can be used to treat JIA?

Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, can be used to ease pain and lower inflammation. These are taken in tablet or liquid form. Corticosteroids, such as prednisone, can also be used to lower swelling. These can be given as tablets, liquid, injection into the joint, or drops into the eye. Disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate, can be used to stop arthritis from spreading and can be taken in tablet or liquid form or by injection.

What is biosample collection and why is it necessary?

Collecting additional blood samples for research helps doctors and scientists answer questions about why kids get JIA and how best to treat each child. You do not have to agree to biosample collection to be part of the Limit-JIA trial. If you do participate, a few extra teaspoons of blood will be drawn around the time of your first appointment, then again at 6 months and 12 months. These blood samples will be studied after the trial is completed to see what changes happened in the blood after receiving the medication and again after stopping it. To learn more about biosample collection, download the brochure.

Are there any costs or payments if my child participates in the clinical trial?

Any usual care costs will be covered by you or your insurance company, as normal. Costs associated with the trial will be paid for by the study. This includes abatacept (Orencia™), study visits, and study lab tests.

What are the risks?

Because abatacept (Orencia™) is approved by the FDA and has been used to treat JIA since 2008, the risks are well understood. Infection (primarily upper respiratory tract) and reactions at the injection site are the most common side effects.

What happens if I decide to withdraw my child after the clinical trial begins?

If you decide to discontinue participation in the study, your child will stop receiving abatacept (Orencia™) but will continue to receive usual care.

What happens if my child needs to stop taking abatacept (Orencia™)?

There may be a reason for your child to stop taking the drug. If this happens, we will make sure your child continues to receive time and attention associated with the trial. During this time, we will still collect important safety and clinical data.

Frequently Asked Questions

Why are we doing the Limit-JIA clinical trial?

Treatment for JIA has come a long way in the last 20 years, with many medications available now to slow or stop the disease. But, usual care of oligoarticular JIA still results in JIA getting worse for about half the children. After JIA gets worse by spreading to more joints or the eyes, children are given a medication like abatacept (Orencia). We want to learn if we can prevent JIA from getting worse by using abatacept (Orencia) as soon as they are diagnosed with oligoarticular JIA.

What is a clinical trial?

A clinical trial is designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. In Limit-JIA, our question is, “Can we prevent oligoarticular JIA from getting worse by using abatacept (Orencia™) in the beginning?”

Can a patient still enroll in the clinical trial?

The enrollment period for the Limit-JIA clinical trial has closed and is no longer able to accept new patients. If you are interested in the results of the trial, please provide your contact information at the bottom of this page, and you’ll receive notifications when additional information is added.

When are the results of the trial expected?

The Limit-JIA clinical trial period includes at least one year of observation for each patient enrolled. Additionally, reviewing the data and understanding the results take time. To receive a notification as more information becomes available, please sign up at the bottom of this page.

How do I receive the results of the Limit-JIA clinical trial?

Please share your contact information in the form at the bottom of this page. You will receive a notification any time more information becomes available. Thank you for your interest in the Limit-JIA clinical trial!

Why is abatacept (Orencia™) being used in this clinical trial?

Abatacept (Orencia™) is approved by the Food and Drug Administration (FDA) to treat moderate to severe JIA. We are testing to see if using it earlier (or, shortly following diagnosis) can help prevent JIA from getting worse, which happens to about half the children who receive usual care.

What other drugs can be used to treat JIA?

Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, can be used to ease pain and lower inflammation. These are taken in tablet or liquid form. Corticosteroids, such as prednisone, can also be used to lower swelling. These can be given as tablets, liquid, injection into the joint, or drops into the eye. Disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate, can be used to stop arthritis from spreading and can be taken in tablet or liquid form or by injection.

What is biosample collection and why is it necessary?

Collecting additional blood samples for research helps doctors and scientists answer questions about why kids get JIA and how best to treat each child. You do not have to agree to biosample collection to be part of the Limit-JIA trial. If you do participate, a few extra teaspoons of blood will be drawn around the time of your first appointment, then again at 6 months and 12 months. These blood samples will be studied after the trial is completed to see what changes happened in the blood after receiving the medication and again after stopping it. To learn more about biosample collection, download the brochure.

Are there any costs or payments if my child participates in the clinical trial?

Any usual care costs will be covered by you or your insurance company, as normal. Costs associated with the trial will be paid for by the study. This includes abatacept (Orencia™), study visits, and study lab tests.

What are the risks?

Because abatacept (Orencia™) is approved by the FDA and has been used to treat JIA since 2008, the risks are well understood. Infection (primarily upper respiratory tract) and reactions at the injection site are the most common side effects.

What happens if I decide to withdraw my child after the clinical trial begins?

If you decide to discontinue participation in the study, your child will stop receiving abatacept (Orencia™) but will continue to receive usual care.

What happens if my child needs to stop taking abatacept (Orencia™)?

There may be a reason for your child to stop taking the drug. If this happens, we will make sure your child continues to receive time and attention associated with the trial. During this time, we will still collect important safety and clinical data.