Role of 90K/Mac-2 BP as an Indicator of Early Response to Infliximab Therapy in IBD Patients

July 18, 2023 updated by: Ahmed Abdelsattar Mohammed Madani, Assiut University
The aim of this study is to analyze the relationship between 90K serum levels measured at baseline and after induction in IBD patient undergoing infliximab therapy, in order to clarify the role of serum 90K as an adjuvant biomarker for IBD patients in the active phase. Furthermore, the study aims to evaluate the clinical usefulness of this new biomarker in the management of IBD patients undergoing infliximab therapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Type of the Study: The current work will be single cohort study.

Study settings: IBD outpatient clinic at Rajhy gastroenterology and Hepatology Hospital at Assiut University Hospital.

Study Duration: June 2023- June 2024 Study population: Participants will be 50 patients were recently diagnosed with Inflammatory Bowel Disease (IBD), Crohn's disease (CD) and Ulcerative Colitis (UC), undergoing the anti-TNF drug infliximab. Infliximab therapy will be administered intravenously initially at a dose of 5 mg/kg/ dose, and then after two and six weeks after the first dose, and fulfill the following inclusion criteria

Inclusion Criteria:

  1. Adult male and female patients aged 18-60 years old.
  2. IBD patients, diagnosis was confirmed by biopsy and histopathology, scheduled for treatment with anti-TNF therapy, Infliximab, and no previous treatment with anti-TNF therapy.

Exclusion Criteria:

  1. Comorbidities (assessed with the Charlson Comorbidity Index).
  2. Ongoing immunosuppressive or immunomodulatory therapy.
  3. A malignant neoplasm in the last 10 years.
  4. Pregnancy or breast feeding.
  5. The need for artificial nutrition.

Study assay:

  1. History taking and clinical examination, including the time and duration of diagnosis, manifestations of disease severity, and previous treatment received.
  2. Laboratory investigations:

A. Routine investigations: such as complete blood count, liver function test (including serum albumin, liver enzymes, bilirubin), kidney function test (serum urea and creatinine, GFR), ESR and C - reactive protein.

B. The concentration of serum 90K glycoprotein is determined by ELISA assay, according to the manufacturer's instruction. Serum levels will be withdrawn before the first dose and after the third dose.

Statistical Tests:

Statistical tests will be performed with frequency and cross tabulations for categorical variables. Data will be reported as Mean+/- Standard Deviation (M +/- SD) for all numerical variables.

Study Type

Observational

Enrollment (Estimated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be 50 patients were recently diagnosed with Inflammatory Bowel Disease (IBD), Crohn's disease (CD) and Ulcerative Colitis (UC), undergoing the anti-TNF drug infliximab. Infliximab therapy will be administered intravenously initially at a dose of 5 mg/kg/ dose, and then after two and six weeks after the first dose, and fulfill the following inclusion criteria

Description

Inclusion Criteria:

  1. Adult male and female patients aged 18-60 years old.
  2. IBD patients, diagnosis was confirmed by biopsy and histopathology, scheduled for treatment with anti-TNF therapy, Infliximab, and no previous treatment with anti-TNF therapy.

Exclusion Criteria:

  • 1. Comorbidities (assessed with the Charlson Comorbidity Index). 2. Ongoing immunosuppressive or immunomodulatory therapy. 3. A malignant neoplasm in the last 10 years. 4. Pregnancy or breast feeding. 5. The need for artificial nutrition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evaluate the clinical usefulness of this new biomarker in the
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 17, 2023

Primary Completion (Estimated)

July 17, 2024

Study Completion (Estimated)

July 17, 2024

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 04-2023-100093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe