A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease (TARGET-IBD)
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ClinicalTrials.gov Identifier: NCT03251118 |
Recruitment Status :
Recruiting
First Posted : August 16, 2017
Last Update Posted : May 4, 2022
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Condition or disease |
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Inflammatory Bowel Diseases Crohn's Disease Ulcerative Colitis Indeterminate Colitis |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 15000 participants |
Observational Model: | Cohort |
Time Perspective: | Other |
Target Follow-Up Duration: | 5 Years |
Official Title: | A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease |
Actual Study Start Date : | July 24, 2017 |
Estimated Primary Completion Date : | July 2025 |
Estimated Study Completion Date : | July 2025 |

- 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 ]
- 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 ]
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251118
Contact: Laura Dalfonso | 9842340268 | ldalfonso@targetpharmasolutions.com |

Responsible Party: | Target PharmaSolutions, Inc. |
ClinicalTrials.gov Identifier: | NCT03251118 |
Other Study ID Numbers: |
TARGET-IBD |
First Posted: | August 16, 2017 Key Record Dates |
Last Update Posted: | May 4, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Crohn's Disease Ulcerative colitis Indeterminate colitis Digestive System Diseases |
Crohn Disease Colitis Colitis, Ulcerative Intestinal Diseases Inflammatory Bowel Diseases Ulcer |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes |