A Study of CDPATH™ to Help Manage and Treat Crohn's Disease

Last updated: January 13, 2025
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

4

Condition

Ulcerative Colitis

Colic

Crohn's Disease

Treatment

Blood Draw

CDPATH™

Clinical Study ID

NCT04809363
Vedolizumab-4015
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Has an initial diagnosis of CD established within five years prior to screening byclinical and endoscopic evidence and corroborated by a histopathology report (ifavailable).

  2. Has agreed to use the CDPATH™ tool.

  3. Has reliable access to the internet and is willing to answer electronicpatient-reported outcomes (ePROs) throughout the study.

Exclusion

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 fistulaother than perianal fistula), non-perianal surgery, bowel resection, orstricturoplasty. A perianal fistula or abscess without other signs of penetratingdisease is allowed.

  2. Has had any non-CD-related abdominal surgery.

  3. Has received investigational biologic or nonbiologic agents for the treatment of CDin an investigational protocol. Approved biologic or nonbiologic agents for CD areallowed.

  4. Has previously used CDPATH™ or PROSPECT results to assess CD risk for complications.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Blood Draw
Phase: 4
Study Start date:
June 25, 2021
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Care Access Research LLC

    Berkeley, California 94705
    United States

    Site Not Available

  • University of Southern California Medical Center

    Irvine, California 92618
    United States

    Site Not Available

  • VA Loma Linda Healthcare System

    Loma Linda, California 92357
    United States

    Site Not Available

  • United Medical Doctors

    Los Alamitos, California 90720
    United States

    Site Not Available

  • UCLA Medical Center Gastro

    Los Angeles, California 90024
    United States

    Site Not Available

  • United Medical Doctors

    Murrieta, California 92563
    United States

    Site Not Available

  • University of Southern California Medical Center

    Newport Beach, California 92663
    United States

    Site Not Available

  • Clinnova Research

    Orange, California 92868
    United States

    Active - Recruiting

  • Clinnova Research Solutions

    Orange, California 92868
    United States

    Site Not Available

  • University of California at Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • Kaiser Permanate of Colorado

    Aurora, Colorado 80014
    United States

    Site Not Available

  • Kaiser Permanate of Colorado

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • West Central Gastroenterology d/b/a Gastro Florida

    Clearwater, Florida 33762
    United States

    Site Not Available

  • Gastroenterology Associates of Pensacola, PA

    Pensacola, Florida 32503
    United States

    Site Not Available

  • West Central Gastroenterology d/b/a Gastro Florida

    Tampa, Florida 33626
    United States

    Site Not Available

  • Emory Healthcare

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Grand Teton Research Group, PLL

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • GI Alliance

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • NorthShore University HealthSystem

    Evanston, Illinois 60201
    United States

    Site Not Available

  • GI Alliance

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Comprehensive Gastrointestinal Health

    Northbrook, Illinois 60062
    United States

    Site Not Available

  • Rockford Gastroenterology Associates, Ltd.

    Rockford, Illinois 61107
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Iowa Digestive Disease Center

    Clive, Iowa 50325
    United States

    Site Not Available

  • University Of Iowa Hospital and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242-1009
    United States

    Site Not Available

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • GI Alliance - Baton Rouge

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Louisiana Research Center, LLC

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • University of Maryland School of Medicine.

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Gastro Center of Maryland

    Columbia, Maryland 21045
    United States

    Site Not Available

  • Lahey Clinic Inc. - PARENT ACCOUNT

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • UMASS Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Digestive Health to Clinical Research Institute of Michigan (CRIM)

    Troy, Michigan 48098
    United States

    Site Not Available

  • Gastroenterology Associates of Western Michigan, P.L.C.

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • BVL Clinical Research

    Liberty, Missouri 64068
    United States

    Site Not Available

  • Atlantic Digestive Health Institute at Morristown

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • University of New Mexico

    Albuquerque, New Mexico 87131-0001
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York, New York 10075-1850
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Clinical Inquest Center Ltd

    Beavercreek, Ohio 45431
    United States

    Site Not Available

  • Dayton Gastroenterology, Inc

    Dayton, Ohio 45415
    United States

    Site Not Available

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Digestive Disease Specialists, Inc.

    Oklahoma City, Oklahoma 73122
    United States

    Site Not Available

  • Options Health Research, LLC

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • The Oregon Clinic, P.C.

    Portland, Oregon 97220-9442
    United States

    Site Not Available

  • Susquehanna Research Group, LLC

    Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Allegheny Center for Digestive Health

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • University of Pittsburgh Medical Center Health System

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania 15478
    United States

    Site Not Available

  • Frontier Clinical Research, LLC

    Uniontown, Pennsylvania 15401
    United States

    Site Not Available

  • Gastroenterology Associates, PA

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Palmetto Primary Care Physician Division of Gastroenterology

    Summerville, South Carolina 29486
    United States

    Site Not Available

  • Rapid City Medical Center, LLC

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37204
    United States

    Site Not Available

  • The University of Texas at Austin

    Austin, Texas 78712
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Pinnacle Clinical Research, PLLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • GI Alliance - Southlake

    Southlake, Texas 76092
    United States

    Site Not Available

  • Care Access Research Berkley

    Ogden, Utah 84403
    United States

    Site Not Available

  • Care Access Research LLC

    Ogden, Utah 84403
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • GCGA Physicians LLC

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Gastroenterology Associates

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Carilion Clinic

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • GI Alliance

    Bellevue, Washington 98405
    United States

    Site Not Available

  • Washington Gastroenterology

    Bellevue, Washington 98405
    United States

    Active - Recruiting

  • University of Washington School of Medicine

    Seattle, Washington 98195
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.