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.
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
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis
- 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
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.
Natural history of Inflammatory Bowel Disease: Characteristics of IBD
Measured: Up to 5 years
Natural history of Inflammatory Bowel Disease: Participant demographics
Measured: Up to 5 years
Natural history of Inflammatory Bowel Disease: Treatment use
Measured: Up to 5 years
Natural history of Inflammatory Bowel Disease: Treatment response
Measured: Up to 5 years
Natural history of Inflammatory Bowel Disease: Disease progression
Measured: Up to 5 years
Secondary outcomes (12)
Endoscopic measures of mucosal healing
Measured: Up to 5 years
Adverse event frequency and severity
Measured: Every 3 months for 5 years
Timepoint of clinical response
Measured: Every 3 months for 5 years
Timepoint of endoscopic response
Measured: Up to 5 years
Reasons for treatment discontinuation
Measured: Up to 5 years
Self-reported patient health measures: EQ-5D
Measured: Every 3 months for 5 years
Self-reported patient health measures: PRO-2 for Crohn's Disease
Measured: Every 3 months for 5 years
Self-reported patient health measures: PRO-2 for Ulcerative colitis
Measured: Every 3 months for 5 years
Self-reported patient health measures: 2-question Adherence Measure
Measured: Every 3 months for 5 years
Self-reported patient health measures: Manitoba IBD Index (MIBDI)
Measured: Every 3 months for 5 years
Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI)
Measured: Every 3 months for 5 years
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.
- First posted16 Aug 2017
- Study start24 Jul 2017
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Target PharmaSolutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03251118
- Acronym / sponsor ID
- TARGET-IBD / TARGET-IBD
- Keywords
- Crohn's Disease, Ulcerative colitis, Indeterminate colitis, Digestive System Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Target PharmaSolutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Natural history of Inflammatory Bowel Disease: Characteristics of IBD
Time frame: Up to 5 years
Natural history of Inflammatory Bowel Disease: Participant demographics
Time frame: Up to 5 years
Natural history of Inflammatory Bowel Disease: Treatment use
Time frame: Up to 5 years
Natural history of Inflammatory Bowel Disease: Treatment response
Time frame: Up to 5 years
Natural history of Inflammatory Bowel Disease: Disease progression
Time frame: Up to 5 years
12 secondary outcomes
Endoscopic measures of mucosal healing
Time frame: Up to 5 years
Adverse event frequency and severity
Time frame: Every 3 months for 5 years
Timepoint of clinical response
Time frame: Every 3 months for 5 years
Timepoint of endoscopic response
Time frame: Up to 5 years
Reasons for treatment discontinuation
Time frame: Up to 5 years
Self-reported patient health measures: EQ-5D
Time frame: 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
Self-reported patient health measures: PRO-2 for Ulcerative colitis
Time frame: Every 3 months for 5 years
Self-reported patient health measures: 2-question Adherence Measure
Time frame: Every 3 months for 5 years
Self-reported patient health measures: Manitoba IBD Index (MIBDI)
Time frame: 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
Timepoint of endoscopic remission
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 1 country: see every site and its status.
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?
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.