CDPATH™ Management Tool for Crohn's Disease

(COMPASS-CD Trial)

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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing CDPATH™, a tool that predicts the risk of complications from Crohn's disease over time. It targets adults with Crohn's disease to help them and their doctors make informed treatment decisions. CDPATH™ uses health data to create a visual risk profile for each patient.

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.

How does the CDPATH™ Management Tool for Crohn's Disease differ from other treatments?

The CDPATH™ Management Tool is unique because it focuses on using eHealth strategies, like mobile apps, to monitor Crohn's disease activity remotely. This approach allows patients to self-assess their condition and communicate with healthcare providers, potentially reducing healthcare costs and improving disease management. ^{1 2 3 4 5}

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

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

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

Treatment Details

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™.

Participant Groups

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

References

1. England pubmed.ncbi.nlm.nih.gov

Crohn's Disease Patient Experiences and Preferences With Disease Monitoring: An International Qualitative Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Circulating cytokines reflect mucosal inflammatory status in patients with Crohn's disease. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The Harvey-Bradshaw Index Adapted to a Mobile Application Compared with In-Clinic Assessment: The MediCrohn Study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Factors predicting the outcome of disease activity assessment in Crohn's disease. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

Using eHealth strategies in delivering dietary and other therapies in patients with irritable bowel syndrome and inflammatory bowel disease. [2022]