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

NCT04131504 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 239

Last updated 2024-01-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Infliximab

No standard dosing regimen will be used and the dose will be determined by the treating physician

DRUG

Adalimumab

No standard dosing regimen will be used and the dose will be determined by the treating physician

Sponsors & Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Phillip Minar, MD, MS · Children's Hospital Medical Center, Cincinnati

Eligibility

Min Age
1 Year
Max Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-16
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04131504 on ClinicalTrials.gov