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

Status unconfirmed

Conditions studied: Crohn Disease, Ulcerative Colitis, IBD, Inflammatory Bowel Diseases

In brief

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.

Key facts

Study ID

NCT03952364

Run by

PredictImmune Ltd

People needed

200

Starts

2019-10-10

Expected to finish

2022-06-01

Last updated by the study team

2021-10-14

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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