Biomarkers to Predict and Monitor Response to Infliximab

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04655729
Collaborator
Crohn's & Colitis Foundation (Other)
120
1
37.5
3.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Prospective, observational study will enroll 120 unique pediatric Crohn's disease patients between the ages of 3-20 years among multiple sites. Patients will be naïve to TNF inhibitor. If patient is going to start infliximab or infliximab biosimilar, patient may be enrolled in study. Study length will be from commencement of infliximab until the infusion visit given at least 1 year after initiation. During the study, if the patient fails infliximab or biosimilar, they will be complete study once failure is indicated and discontinued on infliximab or biosimilar. Patients may be on concurrent IBD therapy such as antibiotics, mesalamines, immunomodulators and may continue in study if non-standard induction schedule or changes made during induction or maintenance to dose or frequency. Excluded patients will be those receiving infliximab or biosimilar infusions at home due to need for blood collection at time of infusion, on systemic corticosteroids (topical preparations such as budesonide are allowed), and those who have already undergone significant bowel surgery relating to their Crohn's.

Study visits will take place in conjunction with previously scheduled routine clinic visits or infusion visits. At initial study visit, demographics, medical and surgical history, PARIS classification, PCDAI, weight and height, fecal calprotectin, labs, EGD and colonoscopy report and pathology report, cross-sectional imaging reports and concurrent medications will be obtained and entered. Parameters measured at each study visit will include any obtained labs, weight and height, PARIS classification, PCDAI, infliximab dose (mg/kg) and dose interval. There will be four study visits throughout the course of 1 year after initiating infliximab. At these four visits, blood will be obtained in PAXgene tubes for RNA analysis and serum for banking for SOMAscan analysis.

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Detection of Serum Protein Biomarkers to Predict and Monitor Response to Infliximab Using SOMAscan
Actual Study Start Date :
Nov 18, 2019
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Define pretreatment serum protein biomarkers that predict and monitor response to TNF inhibitors (Discovery Cohort) [2 years]

    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

Secondary Outcome Measures

  1. Identify pathophysiological mechanisms associated with response or lack of response in patients receiving IFX using SOMAscan. [2 years]

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

  2. Use systems biology to map out pathways activated in those patients at week 14 that have clinical and laboratory response to infliximab [2 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 20 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 MassGeneral for Children Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital
  • Crohn's & Colitis Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Harland S. Winter, MD, Director, Pediatric IBD Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT04655729
Other Study ID Numbers:
  • 2019p002322
First Posted:
Dec 7, 2020
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2022