ClinicalTrials.gg
Active, not recruitingNCT03251118TARGET-IBDUpdated Mar 17, 2026

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

An observational study in Inflammatory Bowel Diseases, Crohn's Disease and Ulcerative Colitis, sponsored by Target PharmaSolutions, Inc.. Active, not recruiting at 37 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by Target PharmaSolutions, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
15,000
Ages
2 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 463 studies in Inflammatory Bowel Diseases with a site in United States — 103 open to participants now, 124 under way, 6 of them phase 3. Inflammatory Bowel Diseases · United States.

Planned enrollment
4th of 132
15,000 · median 134
Started
2017
with 27 others
Observational
133 of 463
39 open now
Primary completion
2027-03
later than 41 of 121 live
Registered
218th of 463
by date

Among the 463 studies in Inflammatory Bowel Diseases with a site in United States, this one is the 4th largest by planned enrollment of the 132 observational ones that give a count, is one of 28 that started in 2017, is one of 133 observational ones, reaches primary completion later than 41 of the 121 other live ones, and was the 218th registered.

Inflammatory Bowel Diseases

1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.

Browse Inflammatory Bowel Diseases studies →

Open to participants now

103 of the 463 studies in Inflammatory Bowel Diseases with a site in United States are open now. Recruiting first, the newest first:

98 more — sign in →

All 103 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 278 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 118 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.

This study: 2 Years and older · all sexes · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Inflammatory Bowel Diseases
  • Crohn's Disease
  • Ulcerative Colitis
  • Indeterminate Colitis

Keywords

  • Crohn's Disease
  • Ulcerative colitis
  • Indeterminate colitis
  • Digestive System Diseases
04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Inability to provide written /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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
15,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

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

    Time frame: Up to 5 years

  2. Natural history of Inflammatory Bowel Disease: Participant demographics

    Time frame: Up to 5 years

  3. Natural history of Inflammatory Bowel Disease: Treatment use

    Time frame: Up to 5 years

  4. Natural history of Inflammatory Bowel Disease: Treatment response

    Time frame: Up to 5 years

  5. Natural history of Inflammatory Bowel Disease: Disease progression

    Time frame: Up to 5 years

Secondary outcomes

  1. Endoscopic measures of mucosal healing

    Time frame: Up to 5 years

  2. Adverse event frequency and severity

    Time frame: Every 3 months for 5 years

  3. Timepoint of clinical response

    Time frame: Every 3 months for 5 years

  4. Timepoint of endoscopic response

    Time frame: Up to 5 years

  5. Reasons for treatment discontinuation

    Time frame: Up to 5 years

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

    Time frame: Every 3 months for 5 years

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

    Time frame: Every 3 months for 5 years

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

    Time frame: Every 3 months for 5 years

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

    Time frame: Every 3 months for 5 years

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

    Time frame: Every 3 months for 5 years

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

    Time frame: Every 3 months for 5 years

  12. Timepoint of endoscopic remission

    Time frame: Up to 5 years

07

Study locations

37 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2017 (actual). Primary completion is estimated for Mar 2027, 116 months after the start.

Of 37 industry-sponsored observational studies under Inflammatory Bowel Diseases, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 44. This study's planned 116 months is above that.

Counting every sponsor, half of 280 studies reached it within 36 months; a quarter within 20 and three quarters within 122.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2017
First posted
Aug 16, 2017
StartActual
Jul 24, 2017
Primary completionEst.
Mar 2027
CompletionEst.
Mar 2027
Last update
Mar 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03251118
Lead sponsor
Target PharmaSolutions, Inc.
Responsible party
Sponsor
First posted
Aug 16, 2017
Start date
Jul 24, 2017
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Mar 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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