Recruiting

Infliximab

Sponsor:

Massachusetts General Hospital

Code:

NCT04655729

Conditions

Crohn Disease

Eligibility Criteria

Sex: All

Age: 3 - 20

Healthy Volunteers: Not accepted

Interventions

Infliximab

Study Details

Brief summary:

The aim of the study is to generate novel minimally-invasive serum protein signatures and biomarkers in children and adolescents with Crohn's Disease (CD) that correlate with and can predict and monitor patients who will have a prolonged response to Infliximab so that personalized medicine can be applied to patients with CD.

Conditions

Crohn Disease

Study ID

NCT04655729

Start date

Nov 18, 2019

Status verified date

Apr, 2022

Completion date

Jan 1, 2023

Anticipated

Primary completion date

Nov 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 20

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Interventions

Infliximab

Blood collection

Primary outcome measure

  • Define pretreatment serum protein biomarkers that predict and monitor response to TNF inhibitors (Discovery Cohort) [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

MassGeneral for Children

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Harland Winter, MD

617-724-2004hwinter@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 13, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2022-04-13.