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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 11 January 2021
Main ID:  NCT04655729
Date of registration: 30/11/2020
Prospective Registration: No
Primary sponsor: Massachusetts General Hospital
Public title: Biomarkers to Predict and Monitor Response to Infliximab
Scientific title: Detection of Serum Protein Biomarkers to Predict and Monitor Response to Infliximab Using SOMAscan
Date of first enrolment: November 18, 2019
Target sample size: 120
Recruitment status: Recruiting
Study type:  Observational
Study design:   
Countries of recruitment
United States
Name:     Harland Winter, MD
Telephone: 617-724-2004
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients between the ages of 3-20 years old

- Patient starting infliximab or infliximab biosimilar,

- Patients naïve to TNF inhibitor

Exclusion Criteria:

- Patients receiving infliximab or biosimilar infusions at home

- Patients already undergone significant bowel surgery relating to their Crohn's.

Age minimum: 3 Years
Age maximum: 20 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Drug: Infliximab
Primary Outcome(s)
Define pretreatment serum protein biomarkers that predict and monitor response to TNF inhibitors (Discovery Cohort) [Time Frame: 2 years]
Secondary Outcome(s)
Identify pathophysiological mechanisms associated with response or lack of response in patients receiving IFX using SOMAscan. [Time Frame: 2 years]
Use systems biology to map out pathways activated in those patients at week 14 that have clinical and laboratory response to infliximab [Time Frame: 2 years]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
The Crohn's and Colitis Foundation
Ethics review
Results available:
Date Posted:
Date Completed:
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