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 |
|
| 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) |
| 48-week follow-up for primary outcome |
Project Information
Key Dates
Study Registration Information
^Arthur Weinstein, MD, was the prinicipal investigator when this project was initially awarded.