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

NCT05230173 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-04-15

No results posted yet for this 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.

Conditions

Interventions

OTHER

Pragmatic

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.

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • Crohn's and Colitis Foundation

    collaborator OTHER

  • Western University

    collaborator OTHER

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • University of California, San Diego

    lead OTHER

Principal Investigators

  • Siddharth Singh, MD · UC San Diego Health

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2028-03-01
Completion
2028-06-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05230173 on ClinicalTrials.gov