A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease

NCT03251118 · tracked via the Priya Life Science USA tracker

Sponsor

Target PharmaSolutions, Inc.

Phase

Observational

Started

2017-07-24

Last updated

2026-03-17

Condition(s) studied

Inflammatory Bowel DiseasesCrohn's DiseaseUlcerative ColitisIndeterminate Colitis

Study summary

TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Eligibility

Sex

ALL

Min age

2 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Adults and children (age 2 or older) with a diagnosis of Crohn's disease (CD), Ulcerative colitis (UC), or Indeterminate colitis (IBDU) having been prescribed any IBD treatment (initial or subsequent) outside of a clinical trial. 2. Have plans for future visits at the site for continued management of IBD. Exclusion Criteria: 1. Inability to provide written informed consent/assent. 2. Being enrolled in any interventional study or trial for IBD treatment. Note: Patient may be enrolled in other registries or studies where IBD treatment outcomes are observed and/or reported (such as center-based registries). 3. Prior total abdominal colectomy for UC or IBDU.

Primary outcome measure(s)

Natural history of Inflammatory Bowel Disease: Characteristics of IBD — Up to 5 years
Natural history of Inflammatory Bowel Disease: Participant demographics — Up to 5 years
Natural history of Inflammatory Bowel Disease: Treatment use — Up to 5 years
Natural history of Inflammatory Bowel Disease: Treatment response — Up to 5 years
Natural history of Inflammatory Bowel Disease: Disease progression — Up to 5 years

Trial sites (37)

Facility	City	Region
Om Research	Lancaster	California
FACEY Medical Foundation	Mission Hills	California
University of California - Davis	Sacramento	California
Stanford University	Stanford	California
University of Colorado Denver	Aurora	Colorado
Gastro Florida	Clearwater	Florida
University of Florida Health Jacksonville-Gastroenterology	Jacksonville	Florida
Advanced Gastroenterology Associates, LLC	Palm Harbor	Florida
Atlanta Gastro	Atlanta	Georgia
The University of Chicago Medical Center	Chicago	Illinois
Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana
University of Iowa Hospitals and Clinics	Iowa City	Iowa
Gastroenterology Associates	Baton Rouge	Louisiana
Louisiana Research Center, LLC	Shreveport	Louisiana
University of Michigan Medical Center	Ann Arbor	Michigan
University of Minnesota	Minneapolis	Minnesota
Saint Louis University	St Louis	Missouri
University of Nebraska Medical Center	Omaha	Nebraska
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
Rutgers, Robert Wood Johnson Medical School	New Brunswick	New Jersey
NYU Langone Health	New York	New York
Mount Sinai, Icahn School of Medicine	New York	New York
Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
The Children's Hospital at Montefiore	The Bronx	New York
Cary Gastroenterology Associates	Cary	North Carolina
University of North Carolina	Chapel Hill	North Carolina
Carolinas Healthcare System-Center for Digestive Health	Charlotte	North Carolina
Digestive Health Specialists, PA	Winston-Salem	North Carolina
Cleveland Clinic/DIgestive Disease and Surgery Institute	Cleveland	Ohio
The Ohio State University Wexner Medical Center	Columbus	Ohio
University of Pennsylvania	Philadelphia	Pennsylvania
Vanderbilt University Medical Center	Nashville	Tennessee
UT Southwestern	Dallas	Texas
Baylor College of Medicine	Houston	Texas
Swedish Medical Center	Seattle	Washington
MultiCare Institute for Research and Innovation	Tacoma	Washington
University of Wisconsin Hospital & Clinics	Madison	Wisconsin

More Target PharmaSolutions, Inc. trials in the USA

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An Observational Study of Patients With Dermatologic Disease Starting soon

An Observational Study of Patients With Chronic Liver Disease Enrolling by invitation

Other trials for the same condition

A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease Active, not recruiting

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease Recruiting

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis Active, not recruiting

A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA) Active, not recruiting

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03251118 on ClinicalTrials.gov ↗ ← All trials in the USA