A Study of CDPATH™ to Help Manage and Treat Crohn's Disease
NCT ID: NCT04809363
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2021-06-25
2026-09-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
CDPATH™
Crohn's disease risk prediction tool.
Blood Draw
Three blood samples will be drawn.
Interventions
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CDPATH™
Crohn's disease risk prediction tool.
Blood Draw
Three blood samples will be drawn.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States
VA Loma Linda Healthcare System
Loma Linda, California, United States
United Medical Doctors
Murrieta, California, United States
University of Southern California Medical Center
Newport Beach, California, United States
Clinnova Research Solutions
Orange, California, United States
University of California at Irvine Medical Center
Orange, California, United States
Kaiser Permanate of Colorado
Aurora, Colorado, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, United States
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, United States
Grand Teton Research Group, PLL
Idaho Falls, Idaho, United States
GI Alliance
Arlington Heights, Illinois, United States
GI Alliance
Gurnee, Illinois, United States
Comprehensive Gastrointestinal Health
Northbrook, Illinois, United States
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Iowa Digestive Disease Center
Clive, Iowa, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
GI Alliance - Baton Rouge
Baton Rouge, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Gastro Center of Maryland
Columbia, Maryland, United States
Lahey Clinic Inc. - PARENT ACCOUNT
Burlington, Massachusetts, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, United States
University of New Mexico
Albuquerque, New Mexico, United States
Lenox Hill Hospital
New York, New York, United States
Clinical Inquest Center Ltd
Beavercreek, Ohio, United States
Dayton Gastroenterology, Inc
Dayton, Ohio, United States
The Oregon Clinic, P.C.
Portland, Oregon, United States
Susquehanna Research Group, LLC
Camp Hill, Pennsylvania, United States
Allegheny Center for Digestive Health
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, United States
Frontier Clinical Research, LLC
Uniontown, Pennsylvania, United States
Palmetto Primary Care Physician Division of Gastroenterology
Summerville, South Carolina, United States
Rapid City Medical Center, LLC
Rapid City, South Dakota, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The University of Texas at Austin
Austin, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
GI Alliance - Southlake
Southlake, Texas, United States
Care Access Research Berkley
Ogden, Utah, United States
University of Utah
Salt Lake City, Utah, United States
GCGA Physicians LLC
Fairfax, Virginia, United States
Gastroenterology Associates
Lynchburg, Virginia, United States
GI Alliance
Bellevue, Washington, United States
Countries
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Related Links
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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.
Other Identifiers
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Vedolizumab-4015
Identifier Type: -
Identifier Source: org_study_id
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