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

Ulcerative Colitis Clinical Trial

— TARGET-IBD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03251118
• Other study ID #: TARGET-IBD
• Status: Recruiting
• Start date: July 24, 2017
• Est. completion date: July 2025

Study information

• Verified date: July 2023
• Source: Target PharmaSolutions, Inc.
• Contact: Laura Dalfonso
• Phone: 9842340268
• Email: ldalfonso[@]targetpharmasolutions.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Atlanta Gastro	Atlanta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Gastroenterology Associates	Baton Rouge	Louisiana
United States	The Children's Hospital at Montefiore	Bronx	New York
United States	Cary Gastroenterology Associates	Cary	North Carolina
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Carolinas Healthcare System-Center for Digestive Health	Charlotte	North Carolina
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	Gastro Florida	Clearwater	Florida
United States	Cleveland Clinic/DIgestive Disease and Surgery Institute	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Florida Health Jacksonville-Gastroenterology	Jacksonville	Florida
United States	Om Research	Lancaster	California
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Wisconsin Hospital & Clinics	Madison	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	FACEY Medical Foundation	Mission Hills	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Rutgers, Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Mount Sinai, Icahn School of Medicine	New York	New York
United States	NYU Langone Health	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Advanced Gastroenterology Associates, LLC	Palm Harbor	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	University of California - Davis	Sacramento	California
United States	Saint Louis University	Saint Louis	Missouri
United States	Swedish Medical Center	Seattle	Washington
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Stanford University	Stanford	California
United States	MultiCare Institute for Research and Innovation	Tacoma	Washington
United States	Digestive Health Specialists, PA	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Target PharmaSolutions, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural history of Inflammatory Bowel Disease: Characteristics of IBD		Up to 5 years
Primary	Natural history of Inflammatory Bowel Disease: Participant demographics		Up to 5 years
Primary	Natural history of Inflammatory Bowel Disease: Treatment use		Up to 5 years
Primary	Natural history of Inflammatory Bowel Disease: Treatment response		Up to 5 years
Primary	Natural history of Inflammatory Bowel Disease: Disease progression		Up to 5 years
Secondary	Endoscopic measures of mucosal healing		Up to 5 years
Secondary	Adverse event frequency and severity		Every 3 months for 5 years
Secondary	Timepoint of clinical response		Every 3 months for 5 years
Secondary	Timepoint of endoscopic response		Up to 5 years
Secondary	Reasons for treatment discontinuation		Up to 5 years
Secondary	Self-reported patient health measures: EQ-5D		Every 3 months for 5 years
Secondary	Self-reported patient health measures: PRO-2 for Crohn's Disease		Every 3 months for 5 years
Secondary	Self-reported patient health measures: PRO-2 for Ulcerative colitis		Every 3 months for 5 years
Secondary	Self-reported patient health measures: 2-question Adherence Measure		Every 3 months for 5 years
Secondary	Self-reported patient health measures: Manitoba IBD Index (MIBDI)		Every 3 months for 5 years
Secondary	Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI)		Every 3 months for 5 years
Secondary	Timepoint of endoscopic remission		Up to 5 years