NCT04809363CompletedPhase 4
A Study of CDPATH™ to Help Manage and Treat Crohn's Disease
A Phase 4 Study Evaluating Real-World Use of CDPATH™, a Crohn's Disease Risk Prediction Tool
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
CDPATH™ is a tool to help predict the potential for developing Crohn's disease related complications in certain adult participants within 3 years. The main aim of the study is to explore the use of CDPATH™ to describe a participant's risk profile and to have discussions with their doctor about the potential path of their Crohn's disease. The number of visits will be decided by the study clinic according to their standard practice.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 241 (actual)
- First submitted
- 19 Mar 2021
- Start date
- Jun 2021
- Primary completion date
- Aug 2026
- Lead sponsor
- Takeda
- Diseases
- Crohn's disease
- NCT number
- NCT04809363
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 241
- From Jun 2021 to the primary completion date, Aug 2026
- 44 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has had any non-CD-related abdominal surgery.
- Has received investigational biologic or nonbiologic agents for the treatment of CD in an investigational protocol. Approved biologic or nonbiologic agents for CD are allowed.
- Has previously used CDPATH™ or PROSPECT results to assess CD risk for complications.
Other illness
- Has had known complications from CD including but not limited to: bowel stricture, CD-related intra-abdominal abscess, internal penetrating disease (known fistula other than perianal fistula), non-perianal surgery, bowel resection, or stricturoplasty. A perianal fistula or abscess without other signs of penetrating disease is allowed.
Who the study is looking for
- Has an initial diagnosis of CD established within five years prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report (if available).
- Has agreed to use the CDPATH™ tool.
- Has reliable access to the internet and is willing to answer electronic patient-reported outcomes (ePROs) throughout the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of New Mexico Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| GI Alliance Coordinator of this site? Confirm its status | Arlington Heights | United States | Unknown status |
| Kaiser Permanate of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| The University of Texas at Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| GI Alliance - Baton Rouge Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Clinical Inquest Center Ltd Coordinator of this site? Confirm its status | Beavercreek | United States | Unknown status |
| GI Alliance Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Lahey Clinic Inc. - PARENT ACCOUNT Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Susquehanna Research Group, LLC Coordinator of this site? Confirm its status | Camp Hill | United States | Unknown status |
| West Central Gastroenterology d/b/a Gastro Florida Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Iowa Digestive Disease Center Coordinator of this site? Confirm its status | Clive | United States | Unknown status |
| Gastro Center of Maryland Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Dayton Gastroenterology, Inc Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| GCGA Physicians LLC Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| GI Alliance Coordinator of this site? Confirm its status | Gurnee | United States | Unknown status |
| Medical Research Center of Connecticut, LLC Coordinator of this site? Confirm its status | Hamden | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Grand Teton Research Group, PLL Coordinator of this site? Confirm its status | Idaho Falls | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Iowa Hospitals & Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of Kansas Medical Center Research Institute, Inc Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| VA Loma Linda Healthcare System Coordinator of this site? Confirm its status | Loma Linda | United States | Unknown status |
| Gastroenterology Associates Coordinator of this site? Confirm its status | Lynchburg | United States | Unknown status |
| United Medical Doctors Coordinator of this site? Confirm its status | Murrieta | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| University of Southern California Medical Center Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Lenox Hill Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Comprehensive Gastrointestinal Health Coordinator of this site? Confirm its status | Northbrook | United States | Unknown status |
| Care Access Research Berkley Coordinator of this site? Confirm its status | Ogden | United States | Unknown status |
| Clinnova Research Solutions Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| University of California at Irvine Medical Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Gastroenterology Associates of Pensacola, PA Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Arizona Arthritis & Rheumatology Research, PLLC Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| University of Pittsburgh Medical Center Health System Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Allegheny Center for Digestive Health Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| The Oregon Clinic, P.C. Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Rapid City Medical Center, LLC Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
| Rockford Gastroenterology Associates, Ltd. Coordinator of this site? Confirm its status | Rockford | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Louisiana Research Center, LLC Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| GI Alliance - Southlake Coordinator of this site? Confirm its status | Southlake | United States | Unknown status |
| Palmetto Primary Care Physician Division of Gastroenterology Coordinator of this site? Confirm its status | Summerville | United States | Unknown status |
| Frontier Clinical Research, LLC Coordinator of this site? Confirm its status | Uniontown | United States | Unknown status |
| Umass Memorial Medical Center Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.