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New tool helps predict Crohn's Flare-Ups years in advance

NCT ID NCT04809363

Knowledge-focused Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study looks at how a tool called CDPATH can help predict the risk of serious complications in people with Crohn's disease within the next three years. About 200 adults with Crohn's will use the tool to learn their risk level (low, medium, or high) and discuss treatment options with their doctor. The goal is to see if this tool helps guide treatment decisions and improve conversations about the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

Contacts and locations

Locations

  • Allegheny Center for Digestive Health

    Pittsburgh, Pennsylvania, 15212, United States

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, Arizona, 85032, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Care Access Research Berkley

    Ogden, Utah, 84403, United States

  • Clinical Inquest Center Ltd

    Beavercreek, Ohio, 45431, United States

  • Clinnova Research Solutions

    Orange, California, 92868, United States

  • Comprehensive Gastrointestinal Health

    Northbrook, Illinois, 60062, United States

  • Dayton Gastroenterology, Inc

    Dayton, Ohio, 45415, United States

  • Frontier Clinical Research, LLC

    Uniontown, Pennsylvania, 15401, United States

  • GCGA Physicians LLC

    Fairfax, Virginia, 22031, United States

  • GI Alliance

    Arlington Heights, Illinois, 60005, United States

  • GI Alliance

    Gurnee, Illinois, 60031, United States

  • GI Alliance

    Bellevue, Washington, 98405, United States

  • GI Alliance - Baton Rouge

    Baton Rouge, Louisiana, 70809, United States

  • GI Alliance - Southlake

    Southlake, Texas, 76092, United States

  • Gastro Center of Maryland

    Columbia, Maryland, 21045, United States

  • Gastroenterology Associates

    Lynchburg, Virginia, 24502, United States

  • Gastroenterology Associates of Pensacola, PA

    Pensacola, Florida, 32503, United States

  • Grand Teton Research Group, PLL

    Idaho Falls, Idaho, 83404, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325, United States

  • Kaiser Permanate of Colorado

    Aurora, Colorado, 80014, United States

  • Lahey Clinic Inc. - PARENT ACCOUNT

    Burlington, Massachusetts, 01805, United States

  • Lenox Hill Hospital

    New York, New York, 10075-1850, United States

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105, United States

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518, 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

  • Rockford Gastroenterology Associates, Ltd.

    Rockford, Illinois, 61107, United States

  • Susquehanna Research Group, LLC

    Camp Hill, Pennsylvania, 17011, United States

  • The Oregon Clinic, P.C.

    Portland, Oregon, 97220-9442, United States

  • The University of Texas at Austin

    Austin, Texas, 78712, United States

  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

  • United Medical Doctors

    Murrieta, California, 92563, United States

  • University of California at Irvine Medical Center

    Orange, California, 92868, 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

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001, United States

  • University of Pittsburgh Medical Center Health System

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Southern California Medical Center

    Newport Beach, California, 92663, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • VA Loma Linda Healthcare System

    Loma Linda, California, 92357, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37204, United States

  • West Central Gastroenterology d/b/a Gastro Florida

    Clearwater, Florida, 33762, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.