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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Crohn's Disease
• Intervention / Treatment: Other: CDPATH™; Other: Blood Draw

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Arizona Arthritis & Rheumatology Research, PLLC
  • California
    • Loma Linda, California, United States, 92357
      • VA Loma Linda Healthcare System
    • Murrieta, California, United States, 92563
      • United Medical Doctors
    • Newport Beach, California, United States, 92663
      • University of Southern California Medical Center
    • Orange, California, United States, 92868
      • University of California at Irvine Medical Center
    • Orange, California, United States, 92868
      • Clinnova Research Solutions
  • Colorado
    • Aurora, Colorado, United States, 80014
      • Kaiser Permanate of Colorado
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Medical Research Center of Connecticut, LLC
  • Florida
    • Clearwater, Florida, United States, 33762
      • West Central Gastroenterology d/b/a Gastro Florida
    • Pensacola, Florida, United States, 32503
      • Gastroenterology Associates of Pensacola, PA
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Grand Teton Research Group, PLL
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • GI Alliance
    • Gurnee, Illinois, United States, 60031
      • GI Alliance
    • Northbrook, Illinois, United States, 60062
      • Comprehensive Gastrointestinal Health
    • Rockford, Illinois, United States, 61107
      • Rockford Gastroenterology Associates, Ltd.
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Iowa
    • Clive, Iowa, United States, 50325
      • Iowa Digestive Disease Center
    • Iowa City, Iowa, United States, 52242-1009
      • University of Iowa Hospitals & Clinics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center Research Institute, Inc.
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • GI Alliance - Baton Rouge
    • Shreveport, Louisiana, United States, 71105
      • Louisiana Research Center, LLC
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Gastro Center of Maryland
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Inc. - PARENT ACCOUNT
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131-0001
      • University of New Mexico
  • New York
    • New York, New York, United States, 10075-1850
      • Lenox Hill Hospital
  • Ohio
    • Beavercreek, Ohio, United States, 45431
      • Clinical Inquest Center Ltd
    • Dayton, Ohio, United States, 45415
      • Dayton Gastroenterology, Inc
  • Oregon
    • Portland, Oregon, United States, 97220-9442
      • The Oregon Clinic, P.C.
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Susquehanna Research Group, LLC
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center Health System
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Center for Digestive Health
    • Uniontown, Pennsylvania, United States, 15401
      • Frontier Clinical Research, LLC
  • South Carolina
    • Summerville, South Carolina, United States, 29486
      • Palmetto Primary Care Physician Division of Gastroenterology
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Medical Center, LLC
  • Tennessee
    • Nashville, Tennessee, United States, 37204
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78712
      • The University of Texas at Austin
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Southlake, Texas, United States, 76092
      • GI Alliance - Southlake
  • Utah
    • Ogden, Utah, United States, 84403
      • Care Access Research Berkley
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • GCGA Physicians LLC
    • Lynchburg, Virginia, United States, 24502
      • Gastroenterology Associates
  • Washington
    • Bellevue, Washington, United States, 98405
      • GI Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CDPATH™; Participants 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.

Other: CDPATH™; Crohn's disease risk prediction tool.; Other Names: PROSPECT; Other: Blood Draw; Three blood samples will be drawn.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Specific Treatment Path and Choice Based on CDPATH™ Tool, Stratified According to Risk Category	Treatment path (i.e., sequence over time) and choice, by low, medium and high risk, will be chosen to characterize treatment path and choice based on risk stratification.	Up to 36 months
Change From Baseline in Decisional Conflict Scale (DCS) Score	DCS is a validated electronic patient-reported outcome (ePRO) collected via electronically administered patient surveys. It measures personal perceptions of the following responses: uncertainty in choosing options, modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making, and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. DCS involves answering 11 questions of PRO, of which 10 questions can be answered as yes (score = 0) or unsure (score = 2) or no (score =4). The total score will range from 0 to 40. Higher score indicates higher decisional conflict.	Baseline, then every 6 months up to 36 months
Change From Baseline in Work Productivity and Activity Impairment Questionnaire - CD Version (WPAI-CD) Score	WPAI-CD is a validated ePRO collected via electronically administered patient surveys. It consists of six questions that evaluate 4 domain scores: absenteeism (i.e., work time missed), presenteeism (i.e., reduced work productivity), overall work impairment, and activity impairment. Scores are expressed as a percentage of impairment, where higher scores indicate greater impairment and reduced productivity. The total score ranges from 0 (no impairment) to 100% (total loss of work productivity).	Baseline, then every 6 months up to 36 months
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Score	PROMIS Global Health scale is a validated ePRO collected via electronically administered patient surveys. It is a 10-item PRO measuring the overall evaluation of one's physical and mental health. The total score ranges from 0 to 100. The final score will be represented by the T-score metric, in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. A higher PROMIS T-score represents more of the concept being measured (higher Global Health score indicate better health).	Baseline, then every 6 months up to 36 months
Patient-Reported Satisfaction and Experience Score with the CDPATH™ Tool	Participant's satisfaction and experience with the CDPATH™ tool will be assessed based on 15 questions. Negative responses/lower score to/in these questions indicates less satisfaction whereas positive responses/higher score indicates satisfaction with the tool.	Up to 36 months
Number of Participants with Clinical Outcomes	Participants with clinical outcomes describing the disease burden based on treatment path and controlling for risk strata will be reported.	Up to 36 months
Percentage of Participants with Healthcare Resource Utilization	Healthcare resource includes healthcare provider (HCP) visits/referrals, visit to emergency room, hospitalizations, surgery, new CD-related complications, and diagnostic evaluations (e.g., imaging, colonoscopy, etc.).	Up to 36 months
Change from First Assessment in Health Care Provider (HCP)-reported Assessment of the Feasibility and Usability of the CDPATH™ Tool	HCP-reported CDPATH™ satisfaction data will be collected directly from HCPs via electronically administered HCP surveys and entered into the eCRF. HCPs will be queried regarding their satisfaction and experience with the general process, the ease of incorporating the tool in their everyday practice, and the impact of the tool on their treatment recommendations and participant communications. For the 6 questions, HCP will rate on 1-5 scale where, 1=strongly disagree and 5=strongly agree. For remaining 4 questions, written feedback from HCP will be consider. Overall positive responses will indicate higher feasibility and usability.	First assessment (6 months after HCPs first enrolled participant) up to HCP leaves the study or the study ends (up to 36 months)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): September 12, 2026

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: Vedolizumab-4015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No