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

IBD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05960162
• Other study ID #: 04-2023-100093
• Status: Not yet recruiting
• Start date: July 17, 2023
• Est. completion date: July 17, 2024

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 17, 2024
• Est. primary completion date: July 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• IBD

Intervention

Diagnostic Test:
• 90K
Blood test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the clinical usefulness of this new biomarker in the		12 months