A Study of CDPATH™ to Help Manage and Treat Crohn's Disease
COMPASS-CD
A Phase 4 Study Evaluating Real-World Use of CDPATH™, a Crohn's Disease Risk Prediction Tool
1 other identifier
interventional
200
1 country
44
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2021
Longer than P75 for phase_4
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2021
CompletedFirst Posted
Study publicly available on registry
March 22, 2021
CompletedStudy Start
First participant enrolled
June 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 12, 2026
July 23, 2026
July 1, 2026
5.2 years
March 19, 2021
July 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results
The risk profile of an individual participant with CD is the output of the CDPATH™ tool. Categories for CD includes low, medium, high risk of developing a CD complication within 3 years.
Baseline (Day 1)
Secondary Outcomes (8)
Percentage of Participants with Specific Treatment Path and Choice Based on CDPATH™ Tool, Stratified According to Risk Category
Up to 36 months
Change From Baseline in Decisional Conflict Scale (DCS) Score
Baseline, then every 6 months up to 36 months
Change From Baseline in Work Productivity and Activity Impairment Questionnaire - CD Version (WPAI-CD) Score
Baseline, then every 6 months up to 36 months
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Score
Baseline, then every 6 months up to 36 months
Patient-Reported Satisfaction and Experience Score with the CDPATH™ Tool
Up to 36 months
- +3 more secondary outcomes
Study Arms (1)
CDPATH™
EXPERIMENTALParticipants with CD will be using CDPATH™ tool. Clinical data will be collected via an ongoing registry. Participants and health care provider (HCP)-reported outcomes data will be collected periodically once every 6 months for up to 36 months via electronic surveys. Two baseline blood samples will be collected at screening for CDPATH™ analysis. 1 additional sample will be collected for future potential biomarker analysis.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (44)
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85032, United States
VA Loma Linda Healthcare System
Loma Linda, California, 92357, United States
United Medical Doctors
Murrieta, California, 92563, United States
University of Southern California Medical Center
Newport Beach, California, 92663, United States
Clinnova Research Solutions
Orange, California, 92868, United States
University of California at Irvine Medical Center
Orange, California, 92868, United States
Kaiser Permanate of Colorado
Aurora, Colorado, 80014, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, 33762, United States
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, 32503, United States
Grand Teton Research Group, PLL
Idaho Falls, Idaho, 83404, United States
GI Alliance
Arlington Heights, Illinois, 60005, United States
GI Alliance
Gurnee, Illinois, 60031, United States
Comprehensive Gastrointestinal Health
Northbrook, Illinois, 60062, United States
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, 61107, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Iowa Digestive Disease Center
Clive, Iowa, 50325, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242-1009, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160, United States
GI Alliance - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Gastro Center of Maryland
Columbia, Maryland, 21045, United States
Lahey Clinic Inc. - PARENT ACCOUNT
Burlington, Massachusetts, 01805, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of New Mexico
Albuquerque, New Mexico, 87131-0001, United States
Lenox Hill Hospital
New York, New York, 10075-1850, United States
Clinical Inquest Center Ltd
Beavercreek, Ohio, 45431, United States
Dayton Gastroenterology, Inc
Dayton, Ohio, 45415, United States
The Oregon Clinic, P.C.
Portland, Oregon, 97220-9442, United States
Susquehanna Research Group, LLC
Camp Hill, Pennsylvania, 17011, United States
Allegheny Center for Digestive Health
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213, United States
Frontier Clinical Research, LLC
Uniontown, Pennsylvania, 15401, United States
Palmetto Primary Care Physician Division of Gastroenterology
Summerville, South Carolina, 29486, United States
Rapid City Medical Center, LLC
Rapid City, South Dakota, 57701, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37204, United States
The University of Texas at Austin
Austin, Texas, 78712, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
GI Alliance - Southlake
Southlake, Texas, 76092, United States
Care Access Research Berkley
Ogden, Utah, 84403, United States
University of Utah
Salt Lake City, Utah, 84132, United States
GCGA Physicians LLC
Fairfax, Virginia, 22031, United States
Gastroenterology Associates
Lynchburg, Virginia, 24502, United States
GI Alliance
Bellevue, Washington, 98405, United States
Related Links
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2021
First Posted
March 22, 2021
Study Start
June 25, 2021
Primary Completion (Estimated)
September 12, 2026
Study Completion (Estimated)
September 12, 2026
Last Updated
July 23, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.