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?

Spondyloarthritis is a type of arthritis that affects the spine and joints. It affects one in three youth with arthritis. Spondyloarthritis can cause symptoms like joint pain, back pain, and eye problems.

Doctors often treat this type of arthritis with a type of medicine called a TNFi. A TNFi can help patients become symptom-free. Patients who don’t have symptoms for at least six months have inactive disease. Questions remain about whether patients should continue taking a TNFi once their disease has become inactive.

In this study, the research team is comparing three ways to treat inactive spondyloarthritis:

  • Continuing to take a standard TNFi.
  • Spacing out the time between TNFi doses.
  • Stopping the TNFi.

The research team is looking at the risk of a disease flare with each treatment approach. A disease flare occurs when patients with inactive disease start to have symptoms again.

Who can this research help?

Results may help doctors, patients, and caregivers considering medicines for children with spondyloarthritis who have inactive disease.

What is the research team doing?

The research team is enrolling 198 youth ages 8–21 from 21 clinics. Youth have spondyloarthritis and sustained inactive disease and are taking TNFi medicines. The team is assigning patients by chance to either continue taking a standard TNFi, increase time between TNFi doses, or stop taking the TNFi.

Patients are visiting their doctors every three months for up to one year. At each visit, patients have a routine physical exam and complete a survey. The survey asks about patients’ experiences including how well they move, feel, and interact with others. The team is also reviewing health records for one year after the study ends to see how often patients in each group have symptoms and what medicines they are taking.

Children and adolescents with spondyloarthritis, caregivers, clinicians, patient advocates, health insurers, and professional organizations are helping to design and conduct this study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 198 children and adolescents ages 8–21 who were diagnosed with spondyloarthritis, with symptom onset before age 16, are being treated with a TNFi, and who have reached a clinically inactive disease state
Interventions/
Comparators
  • Standard TNFi therapy
  • TNFi with longer dosing intervals
  • TNFi therapy withdrawal
Outcomes

Primary: disease flare

Secondary: pain interference

Timeframe Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 1-year follow-up for primary outcome

Project Information

Pamela Weiss, MD, AB
Children's Hospital of Philadelphia
$5,290,770
Biologic Abatement and Capturing Kids? Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)

Key Dates

November 2020
May 2026
2020

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
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: July 6, 2022