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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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