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)
  • Starting a non-TNFi biologic including abatacept, rituximab, sarilumab, or tocilizumab with current methotrexate treatment
  • Starting a tsDMARD including tofacitinib, baricitinib, or upadacitinib with current methotrexate treatment

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

Project Information

Jasvinder Singh, MD, MPH
The University of Alabama at Birmingham
A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients with Rheumatoid Arthritis -- The RA-PRO PRagmatic Trial (RA-PROPR)

Key Dates

November 2020
May 2026

Study Registration Information


Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
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: April 12, 2024