A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
- Conditions
- Inflammatory Bowel DiseasesCrohn's DiseaseUlcerative ColitisIndeterminate Colitis
- Registration Number
- NCT03251118
- Lead Sponsor
- Target PharmaSolutions, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15000
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Natural history of Inflammatory Bowel Disease: Treatment response 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: Characteristics of IBD Up to 5 years Natural history of Inflammatory Bowel Disease: Disease progression Up to 5 years
- Secondary Outcome Measures
Name Time Method 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 Reasons for treatment discontinuation Up to 5 years Self-reported patient health measures: PRO-2 for Ulcerative colitis Every 3 months for 5 years Self-reported patient health measures: Manitoba IBD Index (MIBDI) Every 3 months for 5 years Timepoint of endoscopic response Up to 5 years Self-reported patient health measures: 2-question Adherence Measure Every 3 months for 5 years Timepoint of endoscopic remission Up to 5 years 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 Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI) Every 3 months for 5 years
Trial Locations
- Locations (37)
Om Research
🇺🇸Lancaster, California, United States
FACEY Medical Foundation
🇺🇸Mission Hills, California, United States
University of California - Davis
🇺🇸Sacramento, California, United States
Stanford University
🇺🇸Stanford, California, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Gastro Florida
🇺🇸Clearwater, Florida, United States
University of Florida Health Jacksonville-Gastroenterology
🇺🇸Jacksonville, Florida, United States
Advanced Gastroenterology Associates, LLC
🇺🇸Palm Harbor, Florida, United States
Atlanta Gastro
🇺🇸Atlanta, Georgia, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Gastroenterology Associates
🇺🇸Baton Rouge, Louisiana, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Rutgers, Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
The Children's Hospital at Montefiore
🇺🇸Bronx, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
Mount Sinai, Icahn School of Medicine
🇺🇸New York, New York, United States
Premier Medical Group of the Hudson Valley
🇺🇸Poughkeepsie, 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
Digestive Health Specialists, PA
🇺🇸Winston-Salem, North Carolina, United States
Cleveland Clinic/DIgestive Disease and Surgery Institute
🇺🇸Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
MultiCare Institute for Research and Innovation
🇺🇸Tacoma, Washington, United States
University of Wisconsin Hospital & Clinics
🇺🇸Madison, Wisconsin, United States