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

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byJames Lee, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: PredictImmune Ltd

No Placebo Group

Trial Summary

What is the purpose of this trial?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 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).

+2 more