Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Juvenile idiopathic arthritis, or JIA, is a chronic illness of the immune system that causes children’s joints to become stiff and inflamed. JIA affects up to 300,000 children in the United States. More than half of these children have limited JIA, which affects fewer than five joints. Children with limited JIA may develop arthritis in more joints or inflammation in their eyes. Progressing disease can be hard to treat and can cause complications such as pain, increased joint damage, and growth problems.

In this study, the research team is comparing two ways to treat JIA. The first treatment is standard care. Standard care consists of steroid injections and an anti-inflammatory medicine like ibuprofen. Standard care is effective in relieving acute symptoms of JIA. The second way is standard care plus a medicine called abatacept. Abatacept acts on a part of the immune system that’s involved in the development of arthritis. Adding abatacept may keep the disease from getting worse in children with limited JIA.

Who can this research help?

Results may help doctors, patients, and families who are considering how to treat limited JIA. Results may also help researchers improve patients’ and families’ experiences with JIA trials.

What is the research team doing?

The research team is enrolling 306 children diagnosed with JIA who have not yet begun treatment. The patients are part of a rheumatic disease patient registry with sites across North America. Patient registries store data about people with a specific health problem. The team is assigning children by chance to receive standard care or standard care plus abatacept for 24 weeks. After 24 weeks, all children receive standard care. Eighteen months after the start of the study, the team is looking to see whether patients have inflammation in more than four joints or in the eyes. The team is also looking to see if patients have started a stronger type of medicine called a disease-modifying antirheumatic drug, or DMARD.

The research team is surveying patients and caregivers to learn about patients’ pain, fatigue, ability to function, anxiety, depression, well-being, quality of life, and side effects of medicine. For the youngest patients, only parents complete surveys. For older children, both the patient and a parent complete surveys.

The research team is also asking children with JIA and their parents about the experience of enrolling and taking part in a JIA clinical trial, so they can work to improve the experience.

Parents of children with JIA are helping to plan and conduct the study. An advisory group of parents, patients, a nurse, and a health insurer is also assisting with the study.

Research methods at a glance

Design Elements Description
Design Open label randomized controlled trial
Population 306 patients between the ages of 2 and 16.5 with juvenile idiopathic arthritis that affects 1 to 4 joints who were diagnosed within the past 6 months
Interventions/
Comparators
  • Standard care plus 6 months of abatacept
  • Standard care alone
Outcomes

Primary: extension of disease (5 or more affected joints, development of anterior uveitis, and/or treatment with a disease-modifying agent)

Secondary: patient- and caregiver-reported pain, fatigue, functional ability, anxiety, depression, overall well-being, and health-related quality of life; medicine side effects

Timeframe 18-month follow-up for primary outcomes

Project Information

Laura Schanberg, MD
Duke University
$7,313,586
Improving Outcomes in Limited Juvenile Idiopathic Arthritis

Key Dates

April 2018
October 2023
2018

Study Registration Information

Tags

Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022