Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655729
Status:
UNKNOWN
Last Update Posted:
2022-04-13
First Post:
2020-11-30
Brief Title:
Biomarkers to Predict and Monitor Response to Infliximab
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Detection of Serum Protein Biomarkers to Predict and Monitor Response to Infliximab Using SOMAscan
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to generate novel minimally-invasive serum protein signatures and biomarkers in children and adolescents with Crohns 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
Detailed Description:
Prospective observational study will enroll 120 unique pediatric Crohns 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 Crohns
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 mgkg 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 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 mgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None