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Completed
NCT04809363
A Study of CDPATH™ to Help Manage and Treat Crohn's Disease
Conditions: Crohn's Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 241
Sponsor: Takeda
Location: Arizona Arthritis & Rheumatology Research, PLLC Phoenix Arizona
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 Criteria
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.
Source: ClinicalTrials.gov (NCT04809363). StuddyBuddy aggregates publicly available trial information.