A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease (TARGET-IBD)

March 16, 2026 updated by: Target PharmaSolutions, Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Lancaster, California, United States, 93534
        • Om Research
      • Mission Hills, California, United States, 91345
        • FACEY Medical Foundation
      • Sacramento, California, United States, 95817
        • University of California - Davis
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Florida
      • Clearwater, Florida, United States, 33762
        • Gastro Florida
      • Jacksonville, Florida, United States, 32207
        • University of Florida Health Jacksonville-Gastroenterology
      • Palm Harbor, Florida, United States, 34684
        • Advanced Gastroenterology Associates, LLC
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastro
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology Research Foundation
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gastroenterology Associates
      • Shreveport, Louisiana, United States, 71105
        • Louisiana Research Center, LLC
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota
    • Missouri
      • St Louis, Missouri, United States, 63104
        • Saint Louis University
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03755
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers, Robert Wood Johnson Medical School
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10029
        • Mount Sinai, Icahn School of Medicine
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley
      • The Bronx, New York, United States, 10467
        • The Children's Hospital at Montefiore
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Cary Gastroenterology Associates
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Healthcare System-Center for Digestive Health
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists, PA
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic/DIgestive Disease and Surgery Institute
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical CEnter
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
      • Tacoma, Washington, United States, 98405
        • MultiCare Institute for Research and Innovation
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Hospital & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Natural history of Inflammatory Bowel Disease: Characteristics of IBD
Time Frame: Up to 5 years
Up to 5 years
Natural history of Inflammatory Bowel Disease: Participant demographics
Time Frame: Up to 5 years
Up to 5 years
Natural history of Inflammatory Bowel Disease: Treatment use
Time Frame: Up to 5 years
Up to 5 years
Natural history of Inflammatory Bowel Disease: Treatment response
Time Frame: Up to 5 years
Up to 5 years
Natural history of Inflammatory Bowel Disease: Disease progression
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Endoscopic measures of mucosal healing
Time Frame: Up to 5 years
Up to 5 years
Adverse event frequency and severity
Time Frame: Every 3 months for 5 years
Every 3 months for 5 years
Timepoint of clinical response
Time Frame: Every 3 months for 5 years
Every 3 months for 5 years
Timepoint of endoscopic response
Time Frame: Up to 5 years
Up to 5 years
Reasons for treatment discontinuation
Time Frame: Up to 5 years
Up to 5 years
Self-reported patient health measures: EQ-5D
Time Frame: Every 3 months for 5 years
Every 3 months for 5 years
Self-reported patient health measures: PRO-2 for Crohn's Disease
Time Frame: Every 3 months for 5 years
Every 3 months for 5 years
Self-reported patient health measures: PRO-2 for Ulcerative colitis
Time Frame: Every 3 months for 5 years
Every 3 months for 5 years
Self-reported patient health measures: 2-question Adherence Measure
Time Frame: Every 3 months for 5 years
Every 3 months for 5 years
Self-reported patient health measures: Manitoba IBD Index (MIBDI)
Time Frame: Every 3 months for 5 years
Every 3 months for 5 years
Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI)
Time Frame: Every 3 months for 5 years
Every 3 months for 5 years
Timepoint of endoscopic remission
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Target PharmaSolutions, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2017

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

August 11, 2017

First Posted (Actual)

August 16, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TARGET-IBD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammatory Bowel Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe