Clinical trial NCT03251118: A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
Official title: A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
Keywords: Crohn's Disease
Ulcerative colitis
Indeterminate colitis
Digestive System Diseases
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-16
Enrollment: 15000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Natural history of Inflammatory Bowel Disease: Characteristics of IBD
timeFrame: Up to 5 years
measure: Natural history of Inflammatory Bowel Disease: Participant demographics
timeFrame: Up to 5 years
measure: Natural history of Inflammatory Bowel Disease: Treatment use
timeFrame: Up to 5 years
measure: Natural history of Inflammatory Bowel Disease: Treatment response
timeFrame: Up to 5 years
measure: Natural history of Inflammatory Bowel Disease: Disease progression
timeFrame: Up to 5 years
Secondary outcomes:
measure: Endoscopic measures of mucosal healing
timeFrame: Up to 5 years
measure: Adverse event frequency and severity
timeFrame: Every 3 months for 5 years
measure: Timepoint of clinical response
timeFrame: Every 3 months for 5 years
measure: Timepoint of endoscopic response
timeFrame: Up to 5 years
measure: Reasons for treatment discontinuation
timeFrame: Up to 5 years
measure: Self-reported patient health measures: EQ-5D
timeFrame: Every 3 months for 5 years
measure: Self-reported patient health measures: PRO-2 for Crohn's Disease
timeFrame: Every 3 months for 5 years
measure: Self-reported patient health measures: PRO-2 for Ulcerative colitis
timeFrame: Every 3 months for 5 years
measure: Self-reported patient health measures: 2-question Adherence Measure
timeFrame: Every 3 months for 5 years
measure: Self-reported patient health measures: Manitoba IBD Index (MIBDI)
timeFrame: Every 3 months for 5 years
measure: Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI)
timeFrame: Every 3 months for 5 years
measure: Timepoint of endoscopic remission
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Om Research
state: California
city: Mission Hills
country: United States
facility: FACEY Medical Foundation
state: California
city: Sacramento
country: United States
facility: University of California - Davis
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville-Gastroenterology
state: Florida
city: Palm Harbor
country: United States
facility: Advanced Gastroenterology Associates, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastro
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Baton Rouge
country: United States
facility: Gastroenterology Associates
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New Brunswick
country: United States
facility: Rutgers, Robert Wood Johnson Medical School
state: New Jersey
city: Bronx
country: United States
facility: The Children's Hospital at Montefiore
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Mount Sinai, Icahn School of Medicine
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Cary
country: United States
facility: Cary Gastroenterology Associates
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Healthcare System-Center for Digestive Health
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic/DIgestive Disease and Surgery Institute
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research and Innovation
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
Study officials:
References: