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

NCT03251118 | Active Not Recruiting

• 1 other identifier: TARGET-IBD
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 37

Brief 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.

Conditions

Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis; Indeterminate Colitis

Keywords

Crohn's Disease; Ulcerative colitis; Indeterminate colitis; Digestive System Diseases

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (12)

• Endoscopic measures of mucosal healing

  Up to 5 years

• Adverse event frequency and severity

  Every 3 months for 5 years

• Timepoint of clinical response

  Every 3 months for 5 years

• Timepoint of endoscopic response

  Up to 5 years

• Reasons for treatment discontinuation

  Up to 5 years

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults and children (age 2 or older) with a diagnosis of Crohn's disease, Ulcerative colitis, or Indeterminate colitis having been prescribed any IBD treatment outside of a clinical trial

You may qualify if:

• 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.
• Have plans for future visits at the site for continued management of IBD.

You may not qualify if:

• Inability to provide written informed consent/assent.
• 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).
• Prior total abdominal colectomy for UC or IBDU.

Sponsors & Collaborators

• Target PharmaSolutions, Inc.: lead

Study Sites (37)

Om Research

Lancaster, California, 93534, United States

Location

FACEY Medical Foundation

Mission Hills, California, 91345, United States

Location

University of California - Davis

Sacramento, California, 95817, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Gastro Florida

Clearwater, Florida, 33762, United States

Location

University of Florida Health Jacksonville-Gastroenterology

Jacksonville, Florida, 32207, United States

Location

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684, United States

Location

Atlanta Gastro

Atlanta, Georgia, 30342, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indianapolis Gastroenterology Research Foundation

Indianapolis, Indiana, 46237, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Gastroenterology Associates

Baton Rouge, Louisiana, 70809, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03755, United States

Location

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Mount Sinai, Icahn School of Medicine

New York, New York, 10029, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12601, United States

Location

The Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

Cary Gastroenterology Associates

Cary, North Carolina, 27518, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Healthcare System-Center for Digestive Health

Charlotte, North Carolina, 28204, United States

Location

Digestive Health Specialists, PA

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic/DIgestive Disease and Surgery Institute

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

MultiCare Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53705, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patients enrolled in TARGET-IBD may be invited to participate in the Biorepository Bank (BSB). Blood samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the participant's unique study ID number and the date the sample was obtained. The link between the participant's study ID number and their name will be available only at the site where the samples were obtained.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Digestive System Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 16, 2017
• Study Start: July 24, 2017
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (37)