ClinicalTrials.gov
Cure8 trial brief
A Study of CDPATH™ to Help Manage and Treat Crohn's Disease
Tests and monitoring
Biomarkers
Biomarker
Abscess
Fistula
Phase 3 clinical trial
Adult patients
Clinicians
Why This Matters
Risk-prediction tools like CDPATH™ could help people with Crohn’s disease and their doctors identify higher or lower short-term risk of complications and guide treatment conversations. This study tests how the tool performs and is used in routine clinical practice.
Who Should Pay Attention
Adults with recently diagnosed Crohn’s disease; clinicians treating CD; researchers in biomarkers and risk prediction; patients considering treatment strategy informed by risk stratification.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment200 participants
Study statusActive_not_recruiting
Source depthTrial registry record
What To Know
This is a registered interventional Phase 4 study testing CDPATH™, a risk-prediction tool that uses clinical, serologic, and genetic variables to estimate an individual with Crohn’s disease (CD) risk of developing CD-related complications within three years. About 200 adults diagnosed with CD within the past five years will be enrolled at multiple U.S.
centers; participants will have blood draws for CDPATH™ analysis and one additional sample for potential future biomarker work. Clinical data and patient- and provider-reported outcomes will be collected approximately every six months for up to 36 months as part of routine care.
The study’s main aims are to categorize participants into low/medium/high 3-year complication risk with CDPATH™ at baseline and to evaluate real-world use, satisfaction, and whether CDPATH™ informs treatment discussions.
The protocol excludes people with prior CD complications such as strictures, intra-abdominal abscesses, internal penetrating disease (other than perianal fistula), or prior CD-related bowel surgery.
Keep In Mind
Registered on ClinicalTrials.gov as an interventional Phase 4 study (active, not recruiting). This is a trial record describing planned enrollment, procedures, and outcomes; it does not present efficacy or outcome data.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorTakeda
Trial IDNCT04809363
Study typeInterventional
Trial phasePhase 4
Enrollment200 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedJul 23, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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