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Massive 5-Year IBD study aims to uncover how treatments really work

NCT ID NCT03251118

Knowledge-focused Sponsor: Target PharmaSolutions, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This 5-year observational study is following 15,000 adults and children with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, in real-world clinics. Researchers are collecting data on disease patterns, treatment use, and patient outcomes to better understand how current therapies perform outside of controlled trials. The study does not test a new drug but aims to build a registry that could improve future treatment strategies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could provide valuable insights into how inflammatory bowel disease progresses and how treatments work in everyday practice, potentially guiding future care.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may take years to analyze and may not lead to immediate changes in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 15,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2017

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease Digestive System Diseases indeterminate colitis inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease Indeterminate colitis Inflammatory bowel diseases Ulcerative colitis

Contacts and locations

Locations

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida, 34684, United States

  • Atlanta Gastro

    Atlanta, Georgia, 30342, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Carolinas Healthcare System-Center for Digestive Health

    Charlotte, North Carolina, 28204, United States

  • Cary Gastroenterology Associates

    Cary, North Carolina, 27518, United States

  • Cleveland Clinic/DIgestive Disease and Surgery Institute

    Cleveland, Ohio, 44195, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03755, United States

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina, 27103, United States

  • FACEY Medical Foundation

    Mission Hills, California, 91345, United States

  • Gastro Florida

    Clearwater, Florida, 33762, United States

  • Gastroenterology Associates

    Baton Rouge, Louisiana, 70809, United States

  • Indianapolis Gastroenterology Research Foundation

    Indianapolis, Indiana, 46237, United States

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105, United States

  • Mount Sinai, Icahn School of Medicine

    New York, New York, 10029, United States

  • MultiCare Institute for Research and Innovation

    Tacoma, Washington, 98405, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Om Research

    Lancaster, California, 93534, United States

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601, United States

  • Rutgers, Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901, United States

  • Saint Louis University

    St Louis, Missouri, 63104, United States

  • Stanford University

    Stanford, California, 94305, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • The Children's Hospital at Montefiore

    The Bronx, New York, 10467, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • UT Southwestern

    Dallas, Texas, 75390, United States

  • University of California - Davis

    Sacramento, California, 95817, United States

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

  • University of Florida Health Jacksonville-Gastroenterology

    Jacksonville, Florida, 32207, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55454, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Wisconsin Hospital & Clinics

    Madison, Wisconsin, 53705, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.