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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03952364
• Other study ID #: The Precious Study
• Status: Recruiting
• Start date: October 10, 2019
• Est. completion date: June 2022

Study information

• Verified date: October 2021
• Source: PredictImmune Ltd
• Contact: Karen Hills, PhD
• Phone: +44 (0) 1223 804195
• Email: khills[@]predictimmune.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• IBD
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
United States	ClinSearch	Chattanooga	Tennessee
United States	University of Miami Crohn's and Colitis Center	Miami	Florida
United States	Rutgers Robert Wood Johnson Medical School (Adult)	New Brunswick	New Jersey
United States	Rutgers Robert Wood Johnson Medical School (Prediatric)	New Brunswick	New Jersey
United States	Manhattan Clinical Research, LLC.	New York	New York
United States	NYU Langone Health	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
PredictImmune Ltd	The Crohn's and Colitis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 month follow up