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

NCT ID: NCT03251118

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-24

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Diseases Crohn's Disease Ulcerative Colitis Indeterminate Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Target PharmaSolutions, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Om Research

Lancaster, California, United States

Site Status

FACEY Medical Foundation

Mission Hills, California, United States

Site Status

University of California - Davis

Sacramento, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

University of Colorado Denver

Aurora, Colorado, United States

Site Status

Gastro Florida

Clearwater, Florida, United States

Site Status

University of Florida Health Jacksonville-Gastroenterology

Jacksonville, Florida, United States

Site Status

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, United States

Site Status

Atlanta Gastro

Atlanta, Georgia, United States

Site Status

The University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Indianapolis Gastroenterology Research Foundation

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Gastroenterology Associates

Baton Rouge, Louisiana, United States

Site Status

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Site Status

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Saint Louis University

St Louis, Missouri, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

Mount Sinai, Icahn School of Medicine

New York, New York, United States

Site Status

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, United States

Site Status

The Children's Hospital at Montefiore

The Bronx, New York, United States

Site Status

Cary Gastroenterology Associates

Cary, North Carolina, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Carolinas Healthcare System-Center for Digestive Health

Charlotte, North Carolina, United States

Site Status

Digestive Health Specialists, PA

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic/DIgestive Disease and Surgery Institute

Cleveland, Ohio, United States

Site Status

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

UT Southwestern

Dallas, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

MultiCare Institute for Research and Innovation

Tacoma, Washington, United States

Site Status

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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TARGET-IBD

Identifier Type: -

Identifier Source: org_study_id

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