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 |
|
| Outcomes |
Primary: disease flare Secondary: pain interference |
| Timeframe | 1-year follow-up for primary outcome |