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?
Rheumatoid arthritis, or RA, is an illness in which the immune system attacks healthy tissue. RA can cause pain, damage joints, and limit people’s ability to do daily activities. Doctors first treat RA with a medicine called methotrexate. But for some patients, this medicine doesn’t work on its own. When this happens, doctors may add a medicine called a TNFi biologic. For some patients, adding a TNFi biologic doesn’t help; some patients have negative side effects. For these patients, doctors can add other types of medicine. One type is called a tsDMARD. Another type is called a non-TNFi biologic. But studies haven’t compared how these medicines affect patients’ ability to do daily activities and other outcomes that are important to patients, such as the ability to sleep and work.
In this study, the research team is comparing adding either a tsDMARD or a non-TNFi biologic to methotrexate when treating RA. The team is looking to see how well these medicines work for patients. Also, the team is looking at adverse events. An adverse event is when medical care causes harm, such as when a patient has an allergic reaction to a prescribed medicine.
Who can this research help?
Results may help patients and doctors when considering treatments for RA.
What is the research team doing?
The research team is enrolling 926 adults with RA from 33 sites across the United States and Canada. Patients were treated with a TNFi biologic for at least three months, but they still have symptoms or stopped the medicine because of side effects. The team is assigning patients by chance to start taking a non-TNFi biologic or a tsDMARD. Depending on their assignment, doctors and patients are choosing from one of four non-TNFi biologics or one of three tsDMARDs. After four months, patients can switch to the other type of medicine if their RA doesn’t get better.
Patients are filling out surveys at the start of the study and at regular intervals for a year. Surveys ask about:
- Daily activities such as dressing, eating, and walking
- Sleep
- Fatigue
- How satisfied patients are with treatment
- How productive patients are at work
At clinic visits throughout the year, the research team is asking patients if they had any adverse events.
People with RA, insurers, doctors, and patient advocates are helping to choose outcomes for the study.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 926 adults ages 18 and older with active RA despite treatment with a TNFi biologic (etanercept, infliximab, certolizumab, golimumab, or adalimumab) |
| Interventions/ Comparators |
|
| Outcomes |
Primary: functional limitations including difficulty dressing, arising, eating, walking, hygiene, reach, grip, and activities Secondary: sleep, fatigue, treatment satisfaction, work productivity, disease activity, c-reactive protein, adverse events, serious adverse events, withdrawal due to adverse events |
| Timeframe | 1-year follow-up for primary outcome |