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 (RA) is a disease that causes joint swelling and stiffness, especially in the fingers, wrists, feet, and ankles. RA affects about 1.3 million people in the United States. Doctors often prescribe anti-tumor necrosis factor (anti-TNF) medicine for RA, in addition to standard treatment, to help reduce joint swelling. In some patients, using this medicine can lead to few or no symptoms and normal blood tests, called remission. However, anti-TNF medicine is costly and increases the risk of infection and cancer.

In this study, the research team wants to know if patients with RA who have been in long-term remission while taking anti-TNF medicine are at risk of having symptoms come back if they stop taking the medicine. Researchers are comparing patients who stop taking the medicine with patients who continue taking it. The team also wants to know if disability and joint damage occur more often for patients who stop taking anti-TNF medicine than for patients who keep taking the medicine.

Who can this research help?

Results of this study may help doctors and patients decide whether to continue or stop taking anti-TNF medicine.

What is the research team doing?

The research team is enrolling about 300 patients ages 18 and older who have RA and who have been in remission for at least six months. These patients are taking standard therapy as well as anti-TNF medicine. Participants are continuing to take their standard medicine and either their anti-TNF medicine or a placebo, a formula with no active ingredients. The participants and their doctors do not know whether each patient is receiving the medicine or a placebo.

The team is closely following study participants to check for a flare up of arthritis. Every three months for one year, participants are completing a health survey about joint pain, fatigue, and physical problems. Participants also have a full joint exam and blood tests. After one year passes, the research team is asking participants to complete the health survey every four months for another year. Participants return for a final visit about two years after the study starts.

The research team is looking to see if patients can stop taking anti-TNF medicine without having a flare up of arthritis. The team is also comparing joint damage and ability to do normal daily activities for patients who stop taking the anti-TNF medicine and for patients who continue taking it.

Doctors who treat arthritis are helping to plan the study. Patients and caregivers are helping to make sure the study is focusing on questions that matter to patients.

Research methods at a glance

Design Elements Description
Study Design Randomized controlled trial
Population Adults ages 18 and older who have rheumatoid arthritis controlled with a tumor necrosis factor inhibitor and who have been in remission for at least 6 months
Interventions/
Comparators
  • Anti-tumor necrosis factor agent
  • Placebo
Outcomes

Primary: 48-week remission status (assessed by Disease Activity Score 28)

Secondary: ability to perform daily activities (assessed by the Health Assessment Questionnaire Disability Index), joint damage (assessed by Sharp/van der Heijde radiographic score)

Timeframe 48-week follow-up for primary outcome

Project Information

Florina Constantinescu, MD, PhD^
Georgetown University
$1,793,777
Stopping Anti-Tumor Necrosis Factor Agents in Rheumatoid Arthritis (STARA) Clinical Trial

Key Dates

September 2014
September 2022
2014

Study Registration Information

^Arthur Weinstein, MD, was the prinicipal investigator when this project was initially awarded.

Tags

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: March 4, 2022