Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Nimisha Parekh

Description

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.

Official Title

A Phase 4 Study Evaluating Real-World Use of CDPATH™, a Crohn's Disease Risk Prediction Tool

Details

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 three years, leveraging known participant risk factors based on clinical, serologic and genetic variables to help people categorize risk who have CD. This study will gather data on the use of the tool in real-world settings to inform practical use of CDPATH™. The study will enroll approximately 200 patients. Participants and health care providers (HCPs) will be surveyed to understand their satisfaction with the CDPATH™ process and with their treatment choice. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 36 months. Participants will make multiple visits to the HCP's clinic, and data will be collected approximately every six months up to 3 years, based on the timing of routine follow-up appointments for assessment.

Keywords

Crohn's Disease Drug Therapy Crohn Disease CDPATH™ Blood Draw

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • University of California at Irvine Medical Center not yet accepting patients
    Orange California 92868 United States
  • University of Southern California Medical Center not yet accepting patients
    Irvine California 92618 United States

Lead Scientist at UC Irvine

  • Nimisha Parekh
    Health Sciences Professor, Medicine. Authored (or co-authored) 18 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
Links
To obtain more information on the study, click here/on this link
ID
NCT04809363
Phase
Phase 4
Study Type
Interventional
Last Updated