Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT04131504
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 22 Years
Healthy Volunteers
Accepted

Interventions

  • Infliximab — DRUG
    No standard dosing regimen will be used and the dose will be determined by the treating physician
  • Adalimumab — DRUG
    No standard dosing regimen will be used and the dose will be determined by the treating physician

Study Details

Crohn's disease and ulcerative colitis affect about 1.6 to 3 million people in the United States with many of those being young children and adolescents. Physicians need better ways to inform decisions on therapy selection and recognize ongoing intestinal injury while on treatment. The main reason for this research study is to see if a blood test or stool test, which measures specific proteins, taken just before starting a new treatment for Crohn's disease can predict a patient's ability to achieve complete intestinal healing. The investigators also want to see if the intensity of gut inflammation can be detected by measuring a separate set of proteins in the blood.

Key Dates

Start date
Oct 16, 2019
Status verified
Jan 2024
Primary completion
Oct 31, 2023
Completion
Oct 31, 2023

Study Design

Enrollment
239 participants (actual)

Arms

  • Arm: Phase I - Cross-sectional Study (CD and Suspected IBD)
    150 children and young adults who have been previously diagnosed with CD (anti-TNF naïve) or suspected of having IBD (based on clinical symptoms and laboratory testing) who are scheduled for a clinically-indicated colonoscopy are eligible to be enrolled in this cohort.
  • Arm: Phase I - Cross-sectional Study (healthy volunteers)
    20 healthy controls will be enrolled at Cincinnati Children's Hospital only. Once demographics, past medical/surgical history and biospecimens (blood/stool) are collected, controls will complete participation.
  • Arm: Phase II - Longitudinal Study of Participants with CD
    70 children and young adults who have been diagnosed with CD (anti-TNF naïve) and are scheduled to receive infliximab (or adalimumab) are eligible to be enrolled in this cohort.

Primary Outcome Measure

Sustained Deep Remission [ Time Frame: 1 year ]

Locations (4)

FacilityCityStateZIPSite coordinators
Connecticut Children's Medical CenterHartfordConnecticut06016-
Cincinnati Children's HospitalCincinnatiOhio45229-
Nationwide Children's HospitalColumbusOhio43205-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Hartford, CT

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Connecticut Children's Medical Center· Hartford, CTCincinnati Children's Hospital· Cincinnati, OHNationwide Children's Hospital· Columbus, OHMedical College of Wisconsin· Milwaukee, WI

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