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

• Conditions: Crohn Disease; Ulcerative Colitis; IBD; Inflammatory Bowel Diseases

• Registration Number: NCT03952364
• Lead Sponsor: PredictImmune Ltd

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Study Start: 2019-10-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-14
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To stratify patients at diagnosis into high and low- risk cohorts	12 month follow up	Stratifying patients into high or low risk of following an aggressive disease course requiring frequent treatment escalations.

Trial Locations

Locations (8)

Rutgers Robert Wood Johnson Medical School (Prediatric); 🇺🇸 New Brunswick, New Jersey, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Rutgers Robert Wood Johnson Medical School (Adult); 🇺🇸 New Brunswick, New Jersey, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

ClinSearch; 🇺🇸 Chattanooga, Tennessee, United States

Manhattan Clinical Research, LLC.; 🇺🇸 New York, New York, United States

Weill Cornell Medical Center; 🇺🇸 New York, New York, United States

University of Miami Crohn's and Colitis Center; 🇺🇸 Miami, Florida, United States