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

Last updated: October 12, 2021
Sponsor: PredictImmune Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Crohn's Disease

Gastrointestinal Diseases And Disorders

Inflammatory Bowel Disease

Treatment

N/A

Clinical Study ID

NCT03952364
The Precious Study
  • Ages 16-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Active UC or CD with typical symptoms in conjunction with at least one objectivemeasure of disease activity: elevated CRP, calprotectin, endoscopic evidence.
  • Not currently receiving systemic therapy* with steroids, immunomodulators orbiologics, 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 notreceive biologics as first line therapy).
  • Aged 16-80 years old. Note, the ideal patients for this study are newly diagnosed patients who aretreatment-naïve.

Exclusion

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 afirst line therapy

Study Design

Total Participants: 200
Study Start date:
October 10, 2019
Estimated Completion Date:
June 30, 2022

Study 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.

Connect with a study center

  • University of Miami Crohn's and Colitis Center

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Washington University in St. Louis

    Saint Louis, Missouri 63130
    United States

    Active - Recruiting

  • Rutgers Robert Wood Johnson Medical School (Adult)

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Rutgers Robert Wood Johnson Medical School (Prediatric)

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Manhattan Clinical Research, LLC.

    New York, New York 10016
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Weill Cornell Medical Center

    New York, New York 10065
    United States

    Active - Recruiting

  • ClinSearch

    Chattanooga, Tennessee 37421
    United States

    Active - Recruiting

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