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

NCT03952364 | Unknown DMC

• 1 other identifier: The Precious Study
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 8

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.

Conditions

Crohn Disease; Ulcerative Colitis; IBD; Inflammatory Bowel Diseases

Keywords

Crohn's Disease; Ulcerative Colitis; IBD; Inflammatory Bowel Disease; Precious

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

PredictSURE IBD™ OTHER

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

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target patient populations are newly diagnosed, active CD or UC in patients who are immunomodulator and anti-TNFα treatment naïve.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PredictImmune Ltd: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (8)

University of Miami Crohn's and Colitis Center

Miami, Florida, 33136, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63130, United States

RECRUITING

Rutgers Robert Wood Johnson Medical School (Adult)

New Brunswick, New Jersey, 08901, United States

RECRUITING

Rutgers Robert Wood Johnson Medical School (Prediatric)

New Brunswick, New Jersey, 08901, United States

RECRUITING

Manhattan Clinical Research, LLC.

New York, New York, 10016, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Weill Cornell Medical Center

New York, New York, 10065, United States

RECRUITING

ClinSearch

Chattanooga, Tennessee, 37421, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Following patient consent and recruitment to the study, a 2.5 ml blood sample will be collected in a PAXgene tube.

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• James Lee, MD

  PredictImmune Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Hills, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 16, 2019
• Study Start: October 10, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)