Clinical Trial

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

Study acronym: PROTOS
Active, Not Recruiting
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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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2018-12-04; most recent amendment 2026-05-29.
Status change: Recruiting → Active, Not Recruiting 2023-02-01
Status change: Not Yet Recruiting → Recruiting 2019-03-22
Trial Details
NCT Number NCT03765450
Lead Sponsor Alimentiv Inc.
Conditions Ulcerative Colitis
Enrollment 18 participants
Start Date 2018-12-21
Primary Completion 2023-12-22 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-02