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

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ClinicalTrials.gov Identifier: NCT03952364
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
The Crohn's and Colitis Foundation
Information provided by (Responsible Party):
PredictImmune Ltd

Tracking Information
First Submitted Date May 14, 2019
First Posted Date May 16, 2019
Last Update Posted Date July 19, 2019
Estimated Study Start Date August 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2019)
To stratify patients at diagnosis into high and low- risk cohorts [ Time Frame: 12 month follow up ]
Stratifying patients into high or low risk of following an aggressive disease course requiring frequent treatment escalations.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03952364 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Following patient consent and recruitment to the study, a 2.5 ml blood sample will be collected in a PAXgene tube.
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.
Condition
  • Crohn Disease
  • Ulcerative Colitis
  • IBD
  • Inflammatory Bowel Diseases
Intervention Other: PredictSURE IBD™
To evaluate a test called PredictSURE IBD™ in the US population
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 14, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Karen Hills, PhD +44 (0) 1223 804195 khills@predictimmune.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03952364
Other Study ID Numbers The Precious Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party PredictImmune Ltd
Study Sponsor PredictImmune Ltd
Collaborators The Crohn's and Colitis Foundation
Investigators
Principal Investigator: James Lee, MD PredictImmune Ltd
PRS Account PredictImmune Ltd
Verification Date July 2019