AzTrials
AzTrials

Inflammatory Bowel DiseasesTARGET-IBDNCT03251118

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

An observational study of Inflammatory Bowel Diseases and Crohn's Disease, run by Target PharmaSolutions, Inc. at 37 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 years and older
How many people
15,000 participants
Where
37 sitesUnited States
Study dates
24 Jul 2017to Mar 2027
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

United States37 sites

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • Atlanta Gastro

    Atlanta, Georgia, 30342

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Gastroenterology Associates

    Baton Rouge, Louisiana, 70809

  • Cary Gastroenterology Associates

    Cary, North Carolina, 27518

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Carolinas Healthcare System-Center for Digestive Health

    Charlotte, North Carolina, 28204

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Gastro Florida

    Clearwater, Florida, 33762

  • Cleveland Clinic/DIgestive Disease and Surgery Institute

    Cleveland, Ohio, 44195

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • UT Southwestern

    Dallas, Texas, 75390

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indianapolis Gastroenterology Research Foundation

    Indianapolis, Indiana, 46237

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Florida Health Jacksonville-Gastroenterology

    Jacksonville, Florida, 32207

  • Om Research

    Lancaster, California, 93534

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03755

  • University of Wisconsin Hospital & Clinics

    Madison, Wisconsin, 53705

  • University of Minnesota

    Minneapolis, Minnesota, 55454

  • FACEY Medical Foundation

    Mission Hills, California, 91345

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Rutgers, Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • NYU Langone Health

    New York, New York, 10016

  • Mount Sinai, Icahn School of Medicine

    New York, New York, 10029

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida, 34684

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601

  • University of California - Davis

    Sacramento, California, 95817

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Saint Louis University

    St Louis, Missouri, 63104

  • Stanford University

    Stanford, California, 94305

  • MultiCare Institute for Research and Innovation

    Tacoma, Washington, 98405

  • The Children's Hospital at Montefiore

    The Bronx, New York, 10467

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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.

Keywords
Crohn's Disease, Ulcerative colitis, Indeterminate colitis, Digestive System Diseases
Medical subject headings
Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Digestive System Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Natural history of Inflammatory Bowel Disease: Characteristics of IBD

    Measured: Up to 5 years

  2. Natural history of Inflammatory Bowel Disease: Participant demographics

    Measured: Up to 5 years

  3. Natural history of Inflammatory Bowel Disease: Treatment use

    Measured: Up to 5 years

  4. Natural history of Inflammatory Bowel Disease: Treatment response

    Measured: Up to 5 years

  5. Natural history of Inflammatory Bowel Disease: Disease progression

    Measured: Up to 5 years

Secondary outcomes (12)

  1. Endoscopic measures of mucosal healing

    Measured: Up to 5 years

  2. Adverse event frequency and severity

    Measured: Every 3 months for 5 years

  3. Timepoint of clinical response

    Measured: Every 3 months for 5 years

  4. Timepoint of endoscopic response

    Measured: Up to 5 years

  5. Reasons for treatment discontinuation

    Measured: Up to 5 years

  6. Self-reported patient health measures: EQ-5D

    Measured: Every 3 months for 5 years

  7. Self-reported patient health measures: PRO-2 for Crohn's Disease

    Measured: Every 3 months for 5 years

  8. Self-reported patient health measures: PRO-2 for Ulcerative colitis

    Measured: Every 3 months for 5 years

  9. Self-reported patient health measures: 2-question Adherence Measure

    Measured: Every 3 months for 5 years

  10. Self-reported patient health measures: Manitoba IBD Index (MIBDI)

    Measured: Every 3 months for 5 years

  11. Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI)

    Measured: Every 3 months for 5 years

  12. Timepoint of endoscopic remission

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2017
  2. Study start24 Jul 2017
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
15,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03251118
Sponsor's protocol ID
TARGET-IBD
Acronym
TARGET-IBD
Status last verified
Mar 2026
First submitted
28 Jul 2017
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases and Crohn's Disease, run by Target PharmaSolutions, Inc. at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Natural history of Inflammatory Bowel Disease: Characteristics of IBD (time frame: Up to 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03251118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in