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

Running, not enrolling · Phase 4

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT04809363

Run by

Takeda

People needed

200

Starts

2021-06-25

Expected to finish

2026-09-12

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona, United States
• VA Loma Linda Healthcare System — Loma Linda, California, United States
• United Medical Doctors — Murrieta, California, United States
• University of Southern California Medical Center — Newport Beach, California, United States
• Clinnova Research Solutions — Orange, California, United States
• University of California at Irvine Medical Center — Orange, California, United States
• Kaiser Permanate of Colorado — Aurora, Colorado, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• West Central Gastroenterology d/b/a Gastro Florida — Clearwater, Florida, United States
• Gastroenterology Associates of Pensacola, PA — Pensacola, Florida, United States
• Grand Teton Research Group, PLL — Idaho Falls, Idaho, United States
• GI Alliance — Arlington Heights, Illinois, United States
• GI Alliance — Gurnee, Illinois, United States
• Comprehensive Gastrointestinal Health — Northbrook, Illinois, United States
• Rockford Gastroenterology Associates, Ltd. — Rockford, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Iowa Digestive Disease Center — Clive, Iowa, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States
• GI Alliance - Baton Rouge — Baton Rouge, Louisiana, United States
• Louisiana Research Center, LLC — Shreveport, Louisiana, United States
• Gastro Center of Maryland — Columbia, Maryland, United States
• Lahey Clinic Inc. - PARENT ACCOUNT — Burlington, Massachusetts, United States
• UMASS Memorial Medical Center — Worcester, Massachusetts, United States
• University of New Mexico — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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