Clinical trial NCT03952364: The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States
Official title: The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Ulcerative Colitis
IBD
Inflammatory Bowel Diseases
Keywords: Crohn's Disease
Ulcerative Colitis
IBD
Inflammatory Bowel Disease
Precious
Lead sponsor: PredictImmune Ltd
Sponsor class: INDUSTRY
Collaborators: name: Crohn's and Colitis Foundation
First posted: 2019-05-16
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

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).
* 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

Primary outcomes:
measure: To stratify patients at diagnosis into high and low- risk cohorts
timeFrame: 12 month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Crohn's and Colitis Center
state: Florida
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School (Adult)
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School (Prediatric)
state: New Jersey
city: New York
country: United States
facility: Manhattan Clinical Research, LLC.
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
Study officials:
affiliation: PredictImmune Ltd
name: James Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: