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

Recruiting

This is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) undergoing IBD therapy designed to specifically address important clinical questions that remain incompletely answered from registration trials. Patients being prescribed medical therapy for IBD outside of a clinical trial will be eligible for enrollment. Treatment algorithms will follow each site’s local standard of care and no specific treatments, assessments, and or laboratory tests will be dictated by enrollment in TARGET-IBD. Enrolled patients will consent to the possibility of up to 3 years of retrospective, redacted medical record collection as well as prospective collection for up to 5 years. Medical records will include but will not be limited to: records of hospitalizations, laboratory reports, clinic notes, telephone contact reports, medication lists, reasons for medication initiation and/or discontinuation, endoscopy reports, biopsy results, and imaging results. Patients will also be asked to provide a blood sample for biomarker, anti-drug antibody, and DNA assays and complete patient reported outcome (PRO) surveys, although participation in these two portions of the study is not mandatory for study participation. Consent for linkage of patient health information (PHI) to external healthcare databases (such as patient support programs) will also be requested as an optional portion of the study.

I'm interested

All
2 Years and over
This study is NOT accepting healthy volunteers
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.

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

Crohn's Disease, Ulcerative colitis, Indeterminate colitis, Digestive System Diseases

Shannon Swim - riggs049@umn.edu
Boris Sudel
NA
STUDY00005662
NCT03251118
See this study on ClinicalTrials.gov

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