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NCT07495800
Weight and BMI Patterns in Biological Based IBD Patients and Its Finacial Impact
Conditions: Inflammatory Bowel Diseases Weight Changes
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: Yes
Enrollment: 50
Sponsor: Assiut University
Summary
Primary Objective To determine the pattern of weight and body mass index (BMI) changes in biologic-treated patients with inflammatory bowel disease (IBD).
Secondary Objectives To evaluate the correlation between BMI and biologic drug dosing. To estimate the direct financial burden of biologic therapy according to BMI categories.
To assess whether higher BMI is associated with increased treatment requirements.
Eligibility Criteria
Inclusion Criteria:
* Patients must have received infliximab (IFX) therapy for at least 14 weeks and completed the on-label induction regimen (5 mg/kg IV at weeks 0, 2, and 6), regardless of the dose at the time of blood collection (patients receiving optimized doses are eligible).
* Patients may be on IFX monotherapy or in combination with one of the following medications at the time of selection: aminosalicylates, antibiotics, prednisone, azathioprine, 6-mercaptopurine, or methotrexate.
Exclusion Criteria:
* Patients receiving IFX in combination with tacrolimus, cyclosporine, sirolimus, mycophenolate mofetil, another immunobiological agent, or tofacitinib.
* Patients with insufficient data in their electronic medical records.
Source: ClinicalTrials.gov (NCT07495800). StuddyBuddy aggregates publicly available trial information.