CDPATH™ for Crohn Disease

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Crohn Disease+1 More
CDPATH™ - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Crohn Disease

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Baseline, then every 6 months up to 36 months

Baseline (Day 1)
Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results
Month 36
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
Month 36
Change from First Assessment in Health Care Provider (HCP)-reported Assessment of the Feasibility and Usability of the CDPATH™ Tool
Up to 36 months
Number of Participants with Clinical Outcomes
Patient-Reported Satisfaction and Experience Score with the CDPATH™ Tool
Percentage of Participants with Healthcare Resource Utilization
Percentage of Participants with Specific Treatment Path and Choice Based on CDPATH™ Tool, Stratified According to Risk Category

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

CDPATH™
1 of 1

Experimental Treatment

200 Total Participants · 1 Treatment Group

Primary Treatment: CDPATH™ · No Placebo Group · Phase 4

CDPATH™Experimental Group · 2 Interventions: CDPATH™, Blood Draw · Intervention Types: Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, then every 6 months up to 36 months

Who is running the clinical trial?

TakedaLead Sponsor
1,108 Previous Clinical Trials
4,042,585 Total Patients Enrolled
69 Trials studying Crohn Disease
58,159 Patients Enrolled for Crohn Disease
Study DirectorStudy DirectorTakeda
1,056 Previous Clinical Trials
473,393 Total Patients Enrolled
38 Trials studying Crohn Disease
25,001 Patients Enrolled for Crohn Disease

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of CD established within five years prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report (if available).
You are willing to answer ePROs throughout the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Illinois100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Chicago Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
3+100.0%