Long-term observation of patients with inflammatory bowel disease
A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
Target PharmaSolutions, Inc. · NCT03251118
This study is tracking adults and children with inflammatory bowel disease over five years to see how well their treatments are working in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15000 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Target PharmaSolutions, Inc. (industry) |
| Locations | 37 sites (Lancaster, California and 36 other locations) |
| Trial ID | NCT03251118 on ClinicalTrials.gov |
What this trial studies
TARGET-IBD is a 5-year longitudinal observational study focusing on adult and pediatric patients aged 2 and above who are being treated for inflammatory bowel disease (IBD). The study aims to create a comprehensive research registry that captures real-world data on the safety and effectiveness of current and future IBD therapies. Participants will be managed in both academic and community settings, allowing for a diverse representation of treatment outcomes. The study will track patients over time to gather insights into their health and treatment experiences.
Who should consider this trial
Good fit: Ideal candidates include adults and children aged 2 or older diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis who are receiving IBD treatment outside of clinical trials.
Not a fit: Patients who have undergone total abdominal colectomy for ulcerative colitis or indeterminate colitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable data to improve treatment strategies and outcomes for patients with inflammatory bowel disease.
How similar studies have performed: Other observational studies in similar contexts have shown success in gathering meaningful data on treatment outcomes for inflammatory bowel diseases.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lancaster, California and 36 other locations
- Om Research — Lancaster, California, United States (TERMINATED)
- FACEY Medical Foundation — Mission Hills, California, United States (TERMINATED)
- University of California - Davis — Sacramento, California, United States (RECRUITING)
- Stanford University — Stanford, California, United States (TERMINATED)
- University of Colorado Denver — Aurora, Colorado, United States (RECRUITING)
- Gastro Florida — Clearwater, Florida, United States (RECRUITING)
- University of Florida Health Jacksonville-Gastroenterology — Jacksonville, Florida, United States (TERMINATED)
- Advanced Gastroenterology Associates, LLC — Palm Harbor, Florida, United States (RECRUITING)
- Atlanta Gastro — Atlanta, Georgia, United States (TERMINATED)
- The University of Chicago Medical Center — Chicago, Illinois, United States (RECRUITING)
- Indianapolis Gastroenterology Research Foundation — Indianapolis, Indiana, United States (TERMINATED)
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (RECRUITING)
- Gastroenterology Associates — Baton Rouge, Louisiana, United States (TERMINATED)
- Louisiana Research Center, LLC — Shreveport, Louisiana, United States (TERMINATED)
- University of Michigan Medical Center — Ann Arbor, Michigan, United States (RECRUITING)
- University of Minnesota — Minneapolis, Minnesota, United States (TERMINATED)
- Saint Louis University — Saint Louis, Missouri, United States (TERMINATED)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (RECRUITING)
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (RECRUITING)
- Rutgers, Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (TERMINATED)
- The Children's Hospital at Montefiore — Bronx, New York, United States (TERMINATED)
- NYU Langone Health — New York, New York, United States (RECRUITING)
- Mount Sinai, Icahn School of Medicine — New York, New York, United States (RECRUITING)
- Premier Medical Group of the Hudson Valley — Poughkeepsie, New York, United States (TERMINATED)
- Cary Gastroenterology Associates — Cary, North Carolina, United States (TERMINATED)
- University of North Carolina — Chapel Hill, North Carolina, United States (TERMINATED)
- Carolinas Healthcare System-Center for Digestive Health — Charlotte, North Carolina, United States (RECRUITING)
- Digestive Health Specialists, PA — Winston-Salem, North Carolina, United States (TERMINATED)
- Cleveland Clinic/DIgestive Disease and Surgery Institute — Cleveland, Ohio, United States (TERMINATED)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (TERMINATED)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (TERMINATED)
- UT Southwestern — Dallas, Texas, United States (TERMINATED)
- Baylor College of Medicine — Houston, Texas, United States (TERMINATED)
- Swedish Medical Center — Seattle, Washington, United States (TERMINATED)
- MultiCare Institute for Research and Innovation — Tacoma, Washington, United States (TERMINATED)
- University of Wisconsin Hospital & Clinics — Madison, Wisconsin, United States (RECRUITING)
Study contacts
- Study coordinator: Laura Dalfonso
- Email: ldalfonso@targetpharmasolutions.com
- Phone: 9842340268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, Ulcerative colitis, Indeterminate colitis, Digestive System Diseases