A Study of CDPATH™ to Help Manage and Treat Crohn's Disease

NCT04809363 · tracked via the Priya Life Science USA tracker

Sponsor

Takeda

Phase

Phase 4

Started

2021-06-25

Last updated

2026-07-23

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

CDPATH™Blood Draw

CDPATH™: Crohn's disease risk prediction tool.

Blood Draw: Three blood samples will be drawn.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. 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). 2. Has agreed to use the CDPATH™ tool. 3. Has reliable access to the internet and is willing to answer electronic patient-reported outcomes (ePROs) throughout the study. Exclusion Criteria: 1. 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. 2. Has had any non-CD-related abdominal surgery. 3. 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. 4. Has previously used CDPATH™ or PROSPECT results to assess CD risk for complications.

Primary outcome measure(s)

Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results — Baseline (Day 1)
The risk profile of an individual participant with CD is the output of the CDPATH™ tool. Categories for CD includes low, medium, high risk of developing a CD complication within 3 years.

Trial sites (44)

Facility	City	Region
Arizona Arthritis & Rheumatology Research, PLLC	Phoenix	Arizona
VA Loma Linda Healthcare System	Loma Linda	California
United Medical Doctors	Murrieta	California
University of Southern California Medical Center	Newport Beach	California
Clinnova Research Solutions	Orange	California
University of California at Irvine Medical Center	Orange	California
Kaiser Permanate of Colorado	Aurora	Colorado
Medical Research Center of Connecticut, LLC	Hamden	Connecticut
West Central Gastroenterology d/b/a Gastro Florida	Clearwater	Florida
Gastroenterology Associates of Pensacola, PA	Pensacola	Florida
Grand Teton Research Group, PLL	Idaho Falls	Idaho
GI Alliance	Arlington Heights	Illinois
GI Alliance	Gurnee	Illinois
Comprehensive Gastrointestinal Health	Northbrook	Illinois
Rockford Gastroenterology Associates, Ltd.	Rockford	Illinois
Indiana University	Indianapolis	Indiana
Iowa Digestive Disease Center	Clive	Iowa
University of Iowa Hospitals & Clinics	Iowa City	Iowa
University of Kansas Medical Center Research Institute, Inc.	Kansas City	Kansas
GI Alliance - Baton Rouge	Baton Rouge	Louisiana
Louisiana Research Center, LLC	Shreveport	Louisiana
Gastro Center of Maryland	Columbia	Maryland
Lahey Clinic Inc. - PARENT ACCOUNT	Burlington	Massachusetts
UMASS Memorial Medical Center	Worcester	Massachusetts
University of New Mexico	Albuquerque	New Mexico
Lenox Hill Hospital	New York	New York
Clinical Inquest Center Ltd	Beavercreek	Ohio
Dayton Gastroenterology, Inc	Dayton	Ohio
The Oregon Clinic, P.C.	Portland	Oregon
Susquehanna Research Group, LLC	Camp Hill	Pennsylvania
Allegheny Center for Digestive Health	Pittsburgh	Pennsylvania
University of Pittsburgh Medical Center Health System	Pittsburgh	Pennsylvania
Frontier Clinical Research, LLC	Uniontown	Pennsylvania
Palmetto Primary Care Physician Division of Gastroenterology	Summerville	South Carolina
Rapid City Medical Center, LLC	Rapid City	South Dakota
Vanderbilt University Medical Center	Nashville	Tennessee
The University of Texas at Austin	Austin	Texas
Baylor College of Medicine	Houston	Texas
GI Alliance - Southlake	Southlake	Texas
Care Access Research Berkley	Ogden	Utah

+ 4 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease Recruiting

A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease Recruiting

A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease Active, not recruiting

A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Disease or Ulcerative Colitis (SPECIFI-IBD-LTS) Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04809363 on ClinicalTrials.gov ↗ ← All trials in the USA