A Study of CDPATH™ to Help Manage and Treat Crohn's Disease
About this clinical trial
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.
At a glance
What medical conditions were being studied?
What was the clinical trial testing?
CDPATH™, Blood Draw
How many participants were enrolled?
200
Were placebos part of the clinical trial?
No
When was the clinical trial conducted?
Jun 2021 - Jun 2026
Key requirements
Sexes
All
Age
18+ Years
Healthy volunteers?
No
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.