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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
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

Full criteria on ClinicalTrials.gov

Sites (44)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of New Mexico
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AlbuquerqueUnited StatesUnknown status
GI Alliance
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Arlington HeightsUnited StatesUnknown status
Kaiser Permanate of Colorado
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AuroraUnited StatesUnknown status
The University of Texas at Austin
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AustinUnited StatesUnknown status
GI Alliance - Baton Rouge
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Baton RougeUnited StatesUnknown status
Clinical Inquest Center Ltd
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BeavercreekUnited StatesUnknown status
GI Alliance
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BellevueUnited StatesUnknown status
Lahey Clinic Inc. - PARENT ACCOUNT
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BurlingtonUnited StatesUnknown status
Susquehanna Research Group, LLC
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Camp HillUnited StatesUnknown status
West Central Gastroenterology d/b/a Gastro Florida
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ClearwaterUnited StatesUnknown status
Iowa Digestive Disease Center
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CliveUnited StatesUnknown status
Gastro Center of Maryland
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ColumbiaUnited StatesUnknown status
Dayton Gastroenterology, Inc
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DaytonUnited StatesUnknown status
GCGA Physicians LLC
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FairfaxUnited StatesUnknown status
GI Alliance
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GurneeUnited StatesUnknown status
Medical Research Center of Connecticut, LLC
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HamdenUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
Grand Teton Research Group, PLL
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Idaho FallsUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
University of Iowa Hospitals & Clinics
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Iowa CityUnited StatesUnknown status
University of Kansas Medical Center Research Institute, Inc
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Kansas CityUnited StatesUnknown status
VA Loma Linda Healthcare System
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Loma LindaUnited StatesUnknown status
Gastroenterology Associates
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LynchburgUnited StatesUnknown status
United Medical Doctors
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MurrietaUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
University of Southern California Medical Center
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Newport BeachUnited StatesUnknown status
Lenox Hill Hospital
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New YorkUnited StatesUnknown status
Comprehensive Gastrointestinal Health
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NorthbrookUnited StatesUnknown status
Care Access Research Berkley
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OgdenUnited StatesUnknown status
Clinnova Research Solutions
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OrangeUnited StatesUnknown status
University of California at Irvine Medical Center
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OrangeUnited StatesUnknown status
Gastroenterology Associates of Pensacola, PA
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PensacolaUnited StatesUnknown status
Arizona Arthritis & Rheumatology Research, PLLC
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PhoenixUnited StatesUnknown status
University of Pittsburgh Medical Center Health System
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PittsburghUnited StatesUnknown status
Allegheny Center for Digestive Health
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PittsburghUnited StatesUnknown status
The Oregon Clinic, P.C.
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PortlandUnited StatesUnknown status
Rapid City Medical Center, LLC
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Rapid CityUnited StatesUnknown status
Rockford Gastroenterology Associates, Ltd.
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RockfordUnited StatesUnknown status
University of Utah
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Salt Lake CityUnited StatesUnknown status
Louisiana Research Center, LLC
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ShreveportUnited StatesUnknown status
GI Alliance - Southlake
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SouthlakeUnited StatesUnknown status
Palmetto Primary Care Physician Division of Gastroenterology
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SummervilleUnited StatesUnknown status
Frontier Clinical Research, LLC
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UniontownUnited StatesUnknown status
Umass Memorial Medical Center
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WorcesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.