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CDPATH™ Management Tool for Crohn's Disease (COMPASS-CD Trial)

Phase 4
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, then every 6 months up to 36 months
Awards & highlights

COMPASS-CD Trial Summary

This trial is testing a tool to help predict Crohn's disease complications and to aid discussions with doctors about the disease.

Who is the study for?
This trial is for adults diagnosed with Crohn's Disease within the last five years, who have internet access to complete electronic surveys. Participants must not have had non-Crohn's abdominal surgery or used CDPATH™ before, and should not have severe complications from Crohn's like bowel strictures or abscesses.Check my eligibility
What is being tested?
The study tests CDPATH™, a tool designed to predict the risk of developing complications from Crohn's Disease over three years. It involves regular clinic visits and discussions about disease management based on the participant’s risk profile as determined by CDPATH™.See study design
What are the potential side effects?
Since this trial involves using a predictive tool and providing blood samples rather than testing a medication, there are no direct side effects associated with typical drug interventions.

COMPASS-CD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with Crohn's disease within the last 5 years, confirmed by clinical and endoscopic evidence.

COMPASS-CD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, then every 6 months up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, then every 6 months up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results
Secondary outcome measures
Change From Baseline in Decisional Conflict Scale (DCS) Score
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Score
Change From Baseline in Work Productivity and Activity Impairment Questionnaire - CD Version (WPAI-CD) Score
+5 more

COMPASS-CD Trial Design

1Treatment groups
Experimental Treatment
Group I: CDPATH™Experimental Treatment2 Interventions
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.

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,207 Previous Clinical Trials
4,187,696 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,218 Previous Clinical Trials
499,551 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree could CDPATH™ pose a risk to individuals?

"The safety of CDPATH™ is rated as a 3, indicating that this treatment has been approved after rigorous trials and assessments."

Answered by AI

Have any enrollees been accepted into this experiment yet?

"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial is currently recruiting, having been initially posted on June 25th 2021 and most recently modified on November 10th 2022. Two hundred participants are being sought out from 74 distinct sites."

Answered by AI

How many settings are being utilized to manage this survey?

"Presently, 74 medical centres are running this clinical trial. Including Murrieta, Baltimore and Baton Rouge; all of which offer convenient locations to minimise travel if you become a participant in the study."

Answered by AI

How many individuals are taking part in the experiment?

"This medical research requires 200 individuals to satisfy the eligibility requirements. Patients have the option of joining at United Medical Doctors in Murrieta, California or University of Maryland School of Medicine located in Baltimore, Maryland."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Illinois
Texas
How old are they?
18 - 65
What site did they apply to?
University of Chicago Medical Center
Baylor College of Medicine
Lahey Clinic Inc. - PARENT ACCOUNT
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
~51 spots leftby May 2025