CDPATH™ Management Tool for Crohn's Disease

(COMPASS-CD Trial)

Not currently recruiting at 78 trial locations

Overseen By Patrick Green

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Takeda

Must not be taking: Investigational agents

Disqualifiers: Bowel stricture, Abdominal surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a tool called CDPATH™ to help predict complications in people with Crohn's disease. The goal is to use this tool to assess a participant's risk and facilitate discussions with their doctor about managing their condition over time. The trial seeks participants diagnosed with Crohn's disease within the past five years who have not experienced major complications. Participants should be comfortable using the internet to complete health surveys. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved tool benefits more patients, offering participants a chance to contribute to broader insights on managing Crohn's disease.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, you can continue using approved medications for Crohn's disease.

What is the safety track record for CDPATH™?

Research shows that CDPATH™ predicts the risk of developing complications from Crohn's disease. Studies have confirmed its effectiveness in assessing individual risk. As a Phase 4 study, CDPATH™ has undergone earlier trials, which indicate it is generally safe for use. No reports of negative effects have emerged from using the CDPATH™ tool itself, as it primarily involves analyzing blood samples and providing risk assessments. Participants can therefore expect the tool to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CDPATH™ management tool for Crohn's Disease because it offers a personalized approach to managing the condition. Unlike traditional treatments that focus primarily on managing symptoms through medications like biologics or corticosteroids, CDPATH™ uses a predictive tool to assess the risk of disease complications. This tool relies on clinical data and specific blood biomarkers, allowing healthcare providers to tailor treatment plans more effectively. By potentially identifying risks earlier, CDPATH™ aims to improve long-term outcomes for patients with Crohn's Disease.

What evidence suggests that the CDPATH™ tool is effective for managing Crohn's disease?

Research shows that CDPATH™ helps predict the risk of complications from Crohn's disease using blood tests and a special formula. Studies have demonstrated that this tool provides personalized results, aiding patients and doctors in understanding potential future health issues. It evaluates a person's risk of developing complications related to Crohn's disease over three years. Although not a treatment, it aids decision-making by offering valuable insights into disease progression. By knowing their risk, patients can engage in more informed conversations with healthcare providers about managing their condition. Participants in this trial will use the CDPATH™ tool, with clinical data collected through an ongoing registry. ^{1 2 3 5 6}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are willing to answer ePROs throughout the study.

I was diagnosed with Crohn's disease within the last 5 years, confirmed by clinical and endoscopic evidence.

Has agreed to use the CDPATH™ tool.

Exclusion Criteria

I have Crohn's disease with complications like bowel issues or abscesses, but not perianal fistula alone.

I have taken experimental treatments for Crohn's disease.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline Assessment

Baseline data collection including two blood samples for CDPATH™ analysis

1 day

1 visit (in-person)

Ongoing Data Collection

Participants and HCPs complete surveys every 6 months to assess satisfaction and treatment choices

36 months

Every 6 months (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CDPATH™

Trial Overview 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™.

How Is the Trial Designed?

Group I: CDPATH™ Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Citations

1. cdpath.com cdpath.com/

CDPATH Blood Test to Predict Crohn's Disease Complications Learn more about CDPATH, an innovative tool that utilizes blood tests to predict your potential risk for developing serious Crohn's disease complications.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9802159/

Performance Characteristics of a Clinical Decision Support ... CDPATH (formerly called the Personalized Risk and Outcome Prediction Tool [PROSPECT]) was developed to assess individual risk of CD complications.

3. cdpath.com cdpath.com/hcp

CDPATH For Healthcare Providers CDPATH is a data-driven prognostic tool that uses a novel algorithm to deliver individualized results that can help predict a patient's risk of disease ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04809363

A Study of CDPATH™ to Help Manage and Treat Crohn's ... CDPATH™ is a tool to help predict the potential for developing Crohn's disease related complications in certain adult participants within 3 years.

5. cdpath.com cdpath.com/hcp/crohns-biomarker-test

About CDPATH - Crohn's Disease Biomarker Blood Test The Lémann index is a tool under evaluation designed to assess bowel damage with respect to cumulative damage, progression of damage, and identification of ...

6. cdpath.com cdpath.com/content/pdf/cdpath-development-and-validation-details-hcp.pdf

Model Development and Validation CDPATH is a validated* risk assessment tool that helps adult patients living with Crohn's disease (CD) understand their potential risk for developing ...