A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease (TARGET-IBD)

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 Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis; Indeterminate Colitis

• Study Type: Observational
• Enrollment (Estimated): 15000

Contacts and Locations

• Study Contact: Name: Laura Dalfonso; Phone Number: 9842340268; Email: ldalfonso@targetpharmasolutions.com

Study Locations

• United States
  • California
    • Lancaster, California, United States, 93534
      • Terminated
      • OM Research
    • Mission Hills, California, United States, 91345
      • Terminated
      • Facey Medical Foundation
    • Sacramento, California, United States, 95817
      • Active, not recruiting
      • University of California - Davis
    • Stanford, California, United States, 94305
      • Active, not recruiting
      • Stanford University
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Active, not recruiting
      • University of Colorado Denver
  • Florida
    • Clearwater, Florida, United States, 33762
      • Active, not recruiting
      • Gastro Florida
    • Jacksonville, Florida, United States, 32207
      • Terminated
      • University of Florida Health Jacksonville-Gastroenterology
    • Palm Harbor, Florida, United States, 34684
      • Active, not recruiting
      • Advanced Gastroenterology Associates, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Active, not recruiting
      • Atlanta Gastro
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Active, not recruiting
      • The University of Chicago Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Terminated
      • Indianapolis Gastroenterology Research Foundation
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Active, not recruiting
      • University of Iowa Hospitals and Clinics
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Terminated
      • Gastroenterology Associates
    • Shreveport, Louisiana, United States, 71105
      • Terminated
      • Louisiana Research Center, LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Medical Center
      • Contact: Jermaine Bester; Phone Number: 734-647-1092; Email: jbester@med.umich.edu
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Terminated
      • University of Minnesota
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Terminated
      • Saint Louis University
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Active, not recruiting
      • University of Nebraska Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03755
      • Active, not recruiting
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Terminated
      • Rutgers, Robert Wood Johnson Medical School
  • New York
    • Bronx, New York, United States, 10467
      • Active, not recruiting
      • The Children's Hospital at Montefiore
    • New York, New York, United States, 10016
      • Active, not recruiting
      • NYU Langone Health
    • New York, New York, United States, 10029
      • Active, not recruiting
      • Mount Sinai, Icahn School of Medicine
    • Poughkeepsie, New York, United States, 12601
      • Terminated
      • Premier Medical Group of the Hudson Valley
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Terminated
      • Cary Gastroenterology Associates
    • Chapel Hill, North Carolina, United States, 27599
      • Active, not recruiting
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Active, not recruiting
      • Carolinas Healthcare System-Center for Digestive Health
    • Winston-Salem, North Carolina, United States, 27103
      • Terminated
      • Digestive Health Specialists, PA
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Active, not recruiting
      • Cleveland Clinic/DIgestive Disease and Surgery Institute
    • Columbus, Ohio, United States, 43210
      • Active, not recruiting
      • The Ohio State University Wexner Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Active, not recruiting
      • University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Active, not recruiting
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • Active, not recruiting
      • UT Southwestern
    • Houston, Texas, United States, 77030
      • Active, not recruiting
      • Baylor College of Medicine
  • Washington
    • Seattle, Washington, United States, 98122
      • Terminated
      • Swedish Medical Center
    • Tacoma, Washington, United States, 98405
      • Terminated
      • Multicare Institute for Research and Innovation
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Active, not recruiting
      • University of Wisconsin Hospital & Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• 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

Description

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:

1. Inability to provide written informed consent/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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Natural history of Inflammatory Bowel Disease: Characteristics of IBD	Up to 5 years
Natural history of Inflammatory Bowel Disease: Participant demographics	Up to 5 years
Natural history of Inflammatory Bowel Disease: Treatment use	Up to 5 years
Natural history of Inflammatory Bowel Disease: Treatment response	Up to 5 years
Natural history of Inflammatory Bowel Disease: Disease progression	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Endoscopic measures of mucosal healing	Up to 5 years
Adverse event frequency and severity	Every 3 months for 5 years
Timepoint of clinical response	Every 3 months for 5 years
Timepoint of endoscopic response	Up to 5 years
Reasons for treatment discontinuation	Up to 5 years
Self-reported patient health measures: EQ-5D	Every 3 months for 5 years
Self-reported patient health measures: PRO-2 for Crohn's Disease	Every 3 months for 5 years
Self-reported patient health measures: PRO-2 for Ulcerative colitis	Every 3 months for 5 years
Self-reported patient health measures: 2-question Adherence Measure	Every 3 months for 5 years
Self-reported patient health measures: Manitoba IBD Index (MIBDI)	Every 3 months for 5 years
Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI)	Every 3 months for 5 years
Timepoint of endoscopic remission	Up to 5 years

Collaborators and Investigators

• Sponsor: Target PharmaSolutions, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2017
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Digestive System Diseases; Ulcerative colitis; Crohn's Disease; Indeterminate colitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: TARGET-IBD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No