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
  • Switching targeted immunomodulator treatment
  • Continuing index targeted immunomodulator treatment

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 Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 2-year follow-up for primary outcome

Project Information

Siddharth Singh, MD, MS
Jason Hou, MD, MS
University of California San Diego
Treat-to-Target of Endoscopic Remission in Patients with Inflammatory Bowel Diseases in Symptomatic Remission: A Pragmatic Randomized Controlled Trial

Key Dates

July 2021
April 2028

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
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: September 26, 2023