What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease include biologics like infliximab and adalimumab, thiopurines such as azathioprine and 6-mercaptopurine, and corticosteroids. Biologics can cause side effects like increased risk of infections, infusion reactions, and potential development of antibodies against the medication. Thiopurines may lead to bone marrow suppression, liver toxicity, and increased risk of infections. Corticosteroids are associated with side effects such as weight gain, osteoporosis, hypertension, and increased susceptibility to infections. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several biologic therapies for the treatment of Crohn's Disease, particularly for moderate to severe cases. Infliximab (Remicade) and adalimumab (Humira) are anti-TNF agents that have shown efficacy in inducing and maintaining remission. Certolizumab pegol (Cimzia) is another anti-TNF agent used as a second- or third-line treatment. Ustekinumab (Stelara) and vedolizumab (Entyvio) are other biologics approved for patients who do not respond to anti-TNF therapies. These treatments are relevant to the CDPATH™ study, which aims to predict the risk of complications in Crohn's Disease.

What other types of research exist?

Promising alternatives to CDPATH™ for Crohn's Disease patients include: 1) Machine learning-based prediction models that utilize routinely collected clinical data to predict disease outcomes and surgical needs. 2) Validated risk stratification tools designed to detect high-risk small bowel Crohn's Disease earlier. 3) Advanced imaging techniques like MRI, which are increasingly used for diagnosis and monitoring without ionizing radiation. These tools can help in early detection and personalized management of Crohn's Disease.

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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

Must not have

Has had any non-CD-related abdominal surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, then every 6 months up to 36 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

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.

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™.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had abdominal surgery not related to Crohn's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, then every 6 months up to 36 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results

Secondary study objectives

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Crohn's Disease include glucocorticoids, thiopurines, biologics, and antidiarrheal agents. Glucocorticoids, such as prednisone, reduce inflammation by suppressing the immune system. Thiopurines, like azathioprine and 6-mercaptopurine, inhibit DNA synthesis in immune cells, reducing their activity. Biologics, such as infliximab, target specific proteins involved in the inflammatory process, like TNF-alpha, to reduce inflammation. Antidiarrheal agents, such as loperamide, help manage symptoms by slowing bowel movements. These treatments are crucial for managing inflammation, preventing complications, and improving quality of life for Crohn's Disease patients. The CDPATH™ tool helps predict the risk of complications, allowing for more personalized and effective treatment plans.

The Role of Epidemiological Evidence from Prospective Population Studies in Shaping Dietary Approaches to Therapy in Crohn's Disease.