Biomarkers to Predict and Monitor Response to Infliximab

NCT04655729 | Unknown DMC FDA Drug

• 1 other identifier: 2019p002322
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Define pretreatment serum protein biomarkers that predict and monitor response to TNF inhibitors (Discovery Cohort)

  Run 120 pediatric Crohn's patients' serum at baseline, week 14, and week 54 on SOMAscan; Develop predictor model for protein biomarkers that predict response from baseline serum

  2 years

Secondary Outcomes (2)

• Identify pathophysiological mechanisms associated with response or lack of response in patients receiving IFX using SOMAscan.

  2 years

• Use systems biology to map out pathways activated in those patients at week 14 that have clinical and laboratory response to infliximab

  2 years

Interventions

Infliximab DRUG

Blood collection

Eligibility Criteria

• Age: 3 Years - 20 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients 3-20 years old diagnosed with Crohn's Disease starting infliximab

You may qualify if:

• Patients between the ages of 3-20 years old
• Patient starting infliximab or infliximab biosimilar,
• Patients naïve to TNF inhibitor

You may not qualify if:

• Patients receiving infliximab or biosimilar infusions at home
• Patients already undergone significant bowel surgery relating to their Crohn's.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (1)

MassGeneral for Children

Boston, Massachusetts, 02114, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

SOMAscan analysis Inflammatory bowel disease serum biomarkers

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric IBD Program

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: November 18, 2019
• Primary Completion: November 30, 2022
• Study Completion: January 1, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)