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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.
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:
Exclusion Criteria:
Study assay:
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 Serum levels will be withdrawn before the first dose and after the third dose.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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 90K | Diagnostic Test | Blood test |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the clinical usefulness of this new biomarker in the | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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
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