CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 18 enrolled / 18 target
Drug / intervention
Infliximabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03765450
NCT03765450N/AActiveUpdate Overdue (0.2/mo)Completion was 30mo ago

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

Alimentiv Inc.·observational·Posted Dec 5, 2018·Updated Jun 2, 2026

In Brief

An observational study evaluating Infliximab for Ulcerative Colitis. Active but no longer recruiting, targeting 18 participants across 3 sites in 2 countries.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

N/AActive
2019202020212022202320242025202620272028
First PostedDec 5, 2018
Enrollment StartDec 21, 2018
Primary CompletionDec 22, 2023
Study CompletionDec 1, 2027
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 7.6 years ago

Arms & Interventions

Single Group Studyother

Patients with Acute Severe Ulcerative Colitis who are either a) biologic-naïve or b) biologic-experienced without a known history of anti-infliximab antibodies requiring infliximab infusion therapy as a part of standard of care.

Drug: Infliximab

Interventions

Infliximabdrug

Patients will receive infliximab at the discretion of their physician as part of standard of care.