NCT03765450

Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis

Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Alimentiv Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, prospective, observational study with the primary objective to characterize the pharmacokinetics of infliximab in patients with Acute Severe Ulcerative Colitis.

Detailed description

In Acute Severe Ulcerative Colitis (ASUC), drug exposure may be affected by intestinal protein loss leading to hypoalbuminemia and rapid clearance of infliximab (IFX). Importantly, 2 studies have associated the loss of IFX in stool with poor outcomes. Multiple observational studies have identified that patients with faster IFX clearance have worse clinical outcomes and higher rates of antidrug antibody formation. To better understand optimal dosing of IFX in ASUC, the pharmacokinetics of IFX in association with outcomes must be better defined in this setting.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Infliximab	Patients will receive infliximab at the discretion of their physician as part of standard of care.

Timeline

• Start date: 2018-12-21
• Primary completion: 2023-12-22
• Completion: 2026-03-02
• First posted: 2018-12-05
• Last updated: 2025-05-16

Locations

3 sites across 2 countries: United States, Canada