Status:
ACTIVE_NOT_RECRUITING
A Study of CDPATH™ to Help Manage and Treat Crohn's Disease
Lead Sponsor:
Takeda
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 CD...
Detailed Description
The tool being tested in this study is called CDPATH™. CDPATH™ is being used to provide a graphical representation of an individual participant's risk of developing a CD-related complication within th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 12 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04809363
Start Date
June 25 2021
End Date
September 12 2026
Last Update
November 5 2025
Active Locations (44)
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1
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States, 85032
2
VA Loma Linda Healthcare System
Loma Linda, California, United States, 92357
3
United Medical Doctors
Murrieta, California, United States, 92563
4
University of Southern California Medical Center
Newport Beach, California, United States, 92663