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NCT05230173 · ClinicalTrials.gov registry record · NA

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

A NA study of Ulcerative Colitis and Crohn Disease, sponsored by University of California, San Diego.

Recruiting
Registry status
NA
Development phase
250
Enrollment target
20
Study locations

NCT05230173: Recruiting NA study of Ulcerative Colitis and Crohn Disease, sponsored by University of California, San Diego.

NCT05230173 is a NA study of Ulcerative Colitis and Crohn Disease that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 250 participants, below the 2,055-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05230173, a NA study of Ulcerative Colitis and Crohn Disease, is actively recruiting participants, sponsored by University of California, San Diego.

RECRUITING
Registry status
NA
Development phase
250 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Time to treatment failure, as a composite of: (1) moderate severe symptomatic relapse based on PRO2, with objective confirmation of inflammation within 2 months of event (FC \>250 mcg/g, or CRP \>5mg/L, or endoscopy showing moderate-severe inflammation, or MRE/CTE/IUS showing active inflammation) with need for escalation of therapy; (2) need for rescue therapy with corticosteroids for a documented symptomatic IBD flare; (3) IBD related hospitalization; (4) IBD-related surgery; (5) IBD-related st

Conditions Studied

Ulcerative Colitis Crohn Disease

Interventions

  • OTHER Pragmatic

Study Locations (20)

California

  • Hoag Hospital - Irvine
  • UC San Diego Health - La Jolla
  • Cedars-Sinai - Los Angeles
  • Sutter Health - Palo Alto

New York

  • Saratoga Schenectady Gastroenterology Associates - Burnt Hills
  • NYU Langone Health - New York
  • Cornell University - New York
  • University of Rochester - Rochester

Texas

  • University of Texas Southwestern - Dallas
  • Baylor College of Medicine - Houston

Colorado

  • University of Colorado - Aurora

Connecticut

  • Yale University - New Haven

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.

Florida

  • Mayo Clinic Jacksonville - Jacksonville

Illinois

  • University of Chicago Medicine - Chicago

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2022-10-05
Est. Completion 2028-06-01
Phase NA
University of California, San Diego

775 total trials

What NCT05230173 shows while recruiting

NCT05230173 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 2,055-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (88% lower).

The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Pragmatic is the first listed.

NCT05230173 names 20 study sites across 13 states, led by California, New York, Texas.

Frequently Asked Questions

What is clinical trial NCT05230173 about?

NCT05230173 is a clinical study titled "Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission". 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 ulc...

What is the current status of trial NCT05230173?

This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2022-10-05. Estimated completion is 2028-06-01.

What conditions does trial NCT05230173 study?

This clinical trial studies the following conditions: Ulcerative Colitis, Crohn Disease.

What interventions are being tested in trial NCT05230173?

The interventions under investigation include: Pragmatic (OTHER).

Who is sponsoring clinical trial NCT05230173?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05230173 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Ulcerative Colitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05230173's enrollment target sits among peer trials

250 38th of 122 higher than 85 of 122 other Ulcerative Colitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05230173

Source: ClinicalTrials.gov NCT05230173, the US trial registry maintained by the National Library of Medicine. NCT05230173 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.