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NCT04131504 · ClinicalTrials.gov registry record
Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)
A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- 239
- Enrollment target
NCT04131504: Completed study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04131504 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 239 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04131504 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- 239 participants
- Enrollment target
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.
Primary Outcome
Sustained Deep Remission, defined as meeting all of the following at 1 year (check all that apply): * no wPCDAI score of ≥12.5 on two consecutive visits between week 30-52 * wPCDAI at week 52 is \<12.5 * off prednisone between weeks 30-52 * endoscopic remission (SES-CD\<3)
Interventions
- DRUG Adalimumab
- DRUG Infliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2019-10-16 |
| Est. Completion | 2023-10-31 |
What the finished NCT04131504 record still lists
NCT04131504 is an observational study that tracks outcomes without assigning an intervention. The registered 239 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Adalimumab is the first listed.
NCT04131504 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04131504 about?
NCT04131504 is a clinical study titled "Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)". 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 ...
What is the current status of trial NCT04131504?
This trial is currently completed. The enrollment target is 239 participants. The study started on 2019-10-16. Estimated completion is 2023-10-31.
What interventions are being tested in trial NCT04131504?
The interventions under investigation include: Adalimumab (DRUG), Infliximab (DRUG).
Who is sponsoring clinical trial NCT04131504?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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