RecruitingNot ApplicableNCT05230173

Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission


Sponsor

University of California, San Diego

Enrollment

250 participants

Start Date

Oct 5, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to compare the effectiveness and safety of a strategy of switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis \[UC\]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether achieving complete healing of the gut lining (called endoscopic remission) in patients with inflammatory bowel disease (IBD) who feel well on their current medication leads to better long-term outcomes — compared to just managing symptoms. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) for at least 6 months - You are currently on an approved biologic or small molecule medication for IBD (such as infliximab, adalimumab, ustekinumab, vedolizumab, or a JAK inhibitor) - Your symptoms are currently in remission (you feel well) **You may NOT be eligible if...** - You are currently pregnant or breastfeeding - You have active symptoms or a recent flare of IBD - You have already had complete surgical removal of the affected bowel segment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPragmatic

Patients randomized to a strategy of switching TIM will be switched to one of the preferred agents recommended by clinical guidelines and covered by the patients' insurance formulary as part of routine care, and at the discretion of the site investigator and treating provider. No study-related medications will be provided. Patients (and their providers) in either treatment arm will be allowed to stop or start new TIMs and other IBD-directed therapies in case of symptomatic relapse or intolerance to therapies, at the discretion of the treating provider-patient team.


Locations(22)

Hoag Hospital

Irvine, California, United States

UC San Diego Health

La Jolla, California, United States

Cedars-Sinai

Los Angeles, California, United States

Sutter Health

Palo Alto, California, United States

University of Colorado

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

University of Chicago Medicine

Chicago, Illinois, United States

Dartmouth Hitchcock

Lebanon, New Hampshire, United States

Saratoga Schenectady Gastroenterology Associates

Burnt Hills, New York, United States

NYU Langone Health

New York, New York, United States

Cornell University

New York, New York, United States

University of Rochester

Rochester, New York, United States

Hightower Clinical

Oklahoma City, Oklahoma, United States

Oregon Clinic

Portland, Oregon, United States

Gastroenterology Associates

Providence, Rhode Island, United States

GastroOne

Germantown, Tennessee, United States

University of Texas Southwestern

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

University of Utah Health

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05230173


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