Crohn Disease, IBD, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Keywords
Crohn's Disease, Ulcerative Colitis, IBD, Inflammatory Bowel Disease, Precious
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.
Interventions
OTHERPredictSURE IBD™
To evaluate a test called PredictSURE IBD™ in the US population
Sponsors
Crohn's and Colitis Foundation
PredictImmune Ltd
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To stratify patients at diagnosis into high and low- risk cohorts | 12 month follow up | Stratifying patients into high or low risk of following an aggressive disease course requiring frequent treatment escalations. |
Countries
United States
Contacts
Primary ContactKaren Hills, PhD
Outcome results
None listed