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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.

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Who is running the clinical trial?

TakedaLead Sponsor
1,208 Previous Clinical Trials
4,187,717 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,221 Previous Clinical Trials
499,774 Total Patients Enrolled
~51 spots leftby Jun 2025
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