Recruiting

Observational Study

Sponsor:

PredictImmune Ltd

Code:

NCT03952364

Conditions

Crohn Disease

Ulcerative Colitis

IBD

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

PredictSURE IBD™

Study Details

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.

Conditions

Crohn Disease

Ulcerative Colitis

IBD

Inflammatory Bowel Diseases

Study ID

NCT03952364

Start date

Oct 10, 2019

Status verified date

Oct, 2021

Completion date

Jun, 2022

Anticipated

Primary completion date

Jun, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

PredictSURE IBD™

To evaluate a test called PredictSURE IBD™ in the US population

Primary outcome measure

  • To stratify patients at diagnosis into high and low- risk cohorts [ Time Frame: 12 month follow up ]

Central Contacts and Locations

Central contacts

Karen Hills, PhD

+44 (0) 1223 804195khills@predictimmune.com

Locations

University of Miami Crohn's and Colitis Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Mills Grechen

305-243-6405gmills@med.miami.edu

Principal Investigator:

Oriana Damas, MD

Washington University in St. Louis

Recruiting

Saint Louis, Missouri, United States, 63130

Contacts

Baylee Kinnett

kinnettb@wustl.edu

Principal Investigator:

Deepak Parakkal, MD

Rutgers Robert Wood Johnson Medical School (Adult)

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Roohi Patel, MD

rp583@rwjms.rutgers.edu

Principal Investigator:

Lea Ann Chen, MD

Rutgers Robert Wood Johnson Medical School (Prediatric)

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Lisa Cerracchio

732-235-5976cerracli@rwjms.rutgers.edu

Principal Investigator:

Melissa Weidner, MD

Manhattan Clinical Research, LLC.

Recruiting

New York, New York, United States, 10016

Contacts

Resmi Varughese

212-889-5544rvarughese@vanguardgi.com

Principal Investigator:

Caterina Oneto, MD

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Ghoncheh Ghiasian

646-501-7822ghoncheh.ghiasian@nyulangone.org

Principal Investigator:

Jordan Axelrad, MD

Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Laura Cvetkovski

646-697-0985lac4009@med.cornell.edu

Principal Investigator:

Dana Lukin, MD

ClinSearch

Recruiting

Chattanooga, Tennessee, United States, 37421

Contacts

Misti Earwood

423-698-4584mearwood@clinsearch-us.com

Principal Investigator:

Mark McKenzie, MD

More Information

Sponsor

PredictImmune Ltd

Last update posted

Oct 14, 2021

Last verified

Oct, 2021

Keywords

  • Crohn's Disease
  • Ulcerative Colitis
  • IBD
  • Inflammatory Bowel Disease
  • Precious

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by PredictImmune Ltd on 2021-10-14.