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?
More than 3 million Americans have inflammatory bowel disease, or IBD, such as Crohn’s disease and ulcerative colitis. IBD can cause long-term diarrhea and stomach pain. It can also reduce quality of life and make it hard to go to work or school. Medicines can stop or reduce symptoms of IBD. But many patients who take medicine may still have inflammation in their digestive system. Healing inflammation can lower the risk of IBD flare-ups.
In this study, the research team is looking at whether switching medicine can help reduce inflammation, flare-ups, and the risk of a hospital stay and surgery among people with IBD.
Who can this research help?
Results may help patients and their doctors when considering ways to treat IBD.
What is the research team doing?
The research team is enrolling 478 patients with IBD who have inflammation but no other symptoms. Patients are receiving care at one of 20 health systems across the United States. The team is assigning patients by chance to one of two groups. In the first group, patients are staying on their current medicine. In the second group, patients are switching to another medicine that they choose with their doctor; their choice is based on treatment guidelines and their insurance coverage. In both groups, if patients’ symptoms come back or if the medicine causes unwanted side effects, then they can switch to another medicine.
Patients are answering surveys about their symptoms at the start of study and every three months for two years. Surveys ask about quality of life, treatment burden, and treatment satisfaction. The research team is also collecting data from electronic health records every six months.
Patients with IBD, doctors, and the Crohn’s & Colitis Foundation are helping to plan the study.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 478 adults ages 18–80 with IBD without symptoms who are receiving treatment and who have moderate to severe inflammation on endoscopy |
| Interventions/ Comparators |
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| Outcomes |
Primary: composite time to treatment failure Secondary: composite time to treatment failure, time to moderate to severe symptomatic relapse, time to need for rescue therapy, time to IBD-related hospitalization, time to IBD-related surgery, time to IBD-related structural complications, quality of life, IBD-related disability, treatment burden, treatment satisfaction, safety measured by treatment-related serious adverse events and serious infections |
| Timeframe | 2-year follow-up for primary outcome |