The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States

PredictImmune Ltd200 enrolled

Overview

A multi-center observational study based at referral centers and community hospitals within the US. Patients' blood will be collected at enrollment for testing with PredictSURE IBD™, which will occur at a later date. Patients will be prospectively followed up for 12 months with clinicians treating according to local standard of care, with a step-up or accelerated step-up regimen. Clinicians and patients will be blinded to the biomarker results.

This is a multi-center, observational study of newly diagnosed IBD (CD or UC) patients. The Study aims to assess whether a prognostic biomarker can stratify IBD patients in the US.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Crohn Disease Ulcerative Colitis IBD Inflammatory Bowel Diseases

Interventions

PredictSURE IBD™OTHER

To evaluate a test called PredictSURE IBD™ in the US population

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Active UC or CD with typical symptoms in conjunction with at least one objective measure of disease activity: elevated CRP, calprotectin, endoscopic evidence. * Not currently receiving systemic therapy\* with steroids, immunomodulators or biologics, and at least 7 days since the last steroid dose. * Due to be managed using a "step-up" or "accelerated step-up" approach (so will not receive biologics as first line therapy). * Aged 16-80 years old. Note, the ideal patients for this study are newly diagnosed patients who are treatment-naïve. Exclusion Criteria: * The presence of any of the following will preclude patient inclusion: * Patients with fistulating peri-anal Crohn's disease or active perianal sepsis. * Obstructive symptoms and evidence of a fixed stricture on radiology or colonoscopy. * Patients who are scheduled to start on "top-down" therapy or receive biologics as a first line therapy

Locations (8)

University of Miami Crohn's and Colitis Center

Miami, Florida, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, United States

RECRUITING

Rutgers Robert Wood Johnson Medical School (Adult)

Outcomes

Primary Outcomes

To stratify patients at diagnosis into high and low- risk cohorts

Stratifying patients into high or low risk of following an aggressive disease course requiring frequent treatment escalations.

Time frame: 12 month follow up

Central Contacts

Karen Hills, PhD

CONTACT

+44 (0) 1223 804195 khills@predictimmune.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.