All studies
Active not recruitingOBSERVATIONAL

An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

This study is gathering information about the long-term safety of a medication known as Abatacept, which is used to treat Juvenile Idiopathic Arthritis (JIA) in children and teenagers. JIA is a type of arthritis that affects young people. The main goal is to carefully watch for any serious side effects that might happen over a long period. Researchers are especially interested in whether patients experience serious infections, other autoimmune conditions (where the body's immune system attacks itself), or certain types of cancer. By collecting this information, doctors can better understand how safe Abatacept is for young people with JIA over many years.

At a glance

Status
Active not recruiting
Sponsor
Bristol-Myers Squibb
Enrolment target
800
Start
30 Jan 2013
Estimated completion
02 Jan 2029

What is this study about?

This is an observational study, which means doctors will be watching and collecting information about children and teenagers who are already taking a medication called Abatacept for their Juvenile Idiopathic Arthritis (JIA). JIA is a condition where a child's immune system mistakenly attacks their own joints, causing pain, swelling, and stiffness.

The main purpose of this study is to understand the long-term safety of Abatacept. When a new medicine is first approved, doctors have a good idea of its short-term effects. However, it's really important to keep learning about what happens over many years. This study will specifically look to see if taking Abatacept over a long time is linked to serious infections, other problems with the immune system (called autoimmune disorders), or certain cancers. By gathering this detailed information from a large group of patients, doctors can build a clearer picture of the medicine's safety profile.

This kind of research is important because it helps medical professionals make better decisions about how to treat JIA, ensuring that the treatments are as safe and effective as possible for young patients over their lifetime. It helps improve our understanding of how medicines work in the real world outside of very controlled drug trials.

Key takeaways

  • This study looks at the long-term safety of Abatacept for children with JIA.
  • It's an observational study, meaning researchers will collect information from children already taking the medicine.
  • The main focus is on serious infections, other immune problems, and cancer over time.
  • Participation helps doctors understand Abatacept's safety over many years.
  • You won't receive new medicines as part of the study, only data collection.

Who may be eligible?

To be part of this study, a child or teenager must have been diagnosed with Juvenile Idiopathic Arthritis (JIA). They also need to be under 18 years old when they join, unless they've been in another Abatacept study before.

Crucially, they must already be taking Abatacept for their JIA, either because their doctor decided it was the best treatment for them, or because they received it in an earlier study. A parent or legal guardian must be happy for them to take part and sign a consent form.

However, some children won't be able to join. This includes girls who are pregnant or breastfeeding. Also, anyone who has had certain types of cancer in the past five years, or has another serious ongoing health problem (apart from their JIA), especially a long-term infection, cannot participate. Finally, if it's known that a patient often misses clinic appointments, they won't be suitable for this study.

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.

  1. My child has been diagnosed with Juvenile Idiopathic Arthritis (JIA).
  2. My child is currently taking Abatacept for JIA, or has taken it in a previous study.
  3. My child is under 18 years old, or previously took Abatacept in a clinical trial.
  4. My child is not pregnant or breastfeeding.
  5. My child has not had certain cancers in the last five years and doesn't have other serious ongoing health issues beyond JIA.
Answer every question to see your result.

What does participation involve?

This is an observational study, so you generally won't be given new medicine or treatments as part of the study itself. Instead, the doctors will simply collect information about your child's health and the Abatacept they are already receiving from their own doctor. This means attending regular check-ups as recommended by your child's treating physician, just as you normally would. At these visits, the study team will collect data from your child's medical records. The total duration of participation isn't specified, but as it's a long-term safety study, it will likely involve collecting data over an extended period.

Potential risks and benefits

The main benefit of taking part is contributing to a better understanding of the long-term safety of Abatacept for children and teenagers with JIA. This knowledge can help improve care for future patients. Because this is an observational study and you'll be receiving treatment as usual, there are generally few additional risks directly from the study itself beyond those associated with your child's ongoing medical care and treatment. However, all medical treatments have potential side effects, and your child's doctor will discuss these with you. You and your child always have the right to withdraw from the study at any time, for any reason, without it affecting their medical care.

Locations (59)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Local Institution - 0060
    Verified postcode
    Little Rock, United States
  • Local Institution - 0001
    Verified postcode
    Princeton, United States
  • Local Institution - 0059
    Verified postcode
    Cincinnati, United States
  • Local Institution - 0025
    Verified postcode
    Bregenz, Austria
  • Local Institution - 0002
    Verified postcode
    Innsbruck, Austria
  • Local Institution - 0032
    Verified postcode
    Vienna, Austria
  • Local Institution - 0010
    Verified postcode
    Botucatu, Brazil
  • Local Institution - 0026
    Verified postcode
    Campinas, Brazil
  • Local Institution - 0028
    Verified postcode
    São Paulo, Brazil
  • Local Institution - 0027
    Verified postcode
    Rio de Janeiro, Brazil
  • Local Institution - 0029
    Verified postcode
    Calgary, Canada
  • Local Institution - 0011
    Verified postcode
    Montreal, Canada

Common questions

What is Juvenile Idiopathic Arthritis (JIA)?

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

What is Abatacept?

Abatacept is a medication used to treat JIA, helping to control the immune system's attack on the joints.

Will my child receive new treatment in this study?

No, this study only observes children already taking Abatacept as part of their regular care. No new treatments are given.

What kind of information will be collected?

Doctors will collect information about your child's health from their medical records, focusing on long-term safety, infections, and other health issues.

Can we stop participating at any time?

Yes, you and your child can choose to stop being part of the study at any time without it affecting their medical treatment.

How to find out more

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

Discussion

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