CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 11 enrolled
Drug / intervention
Infliximabdrug
Likely dose
Infliximab 10mg/kgfrom 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/NCT01971814
NCT01971814Phase 1Completed
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Early Serum Infliximab Levels in Severe Ulcerative Colitis

University of California, San Francisco·interventional·Posted Oct 29, 2013·Updated May 29, 2015

In Brief

A Phase 1 clinical trial evaluating Infliximab for Ulcerative Colitis (UC) and Inflammatory Bowel Disease. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The aim of this study is to a.) evaluate whether early serum infliximab levels are predictive of avoidance of colectomy, b) evaluate whether serum albumin levels correlate with serum infliximab levels, and c) evaluate whether serum tumor necrosis factor levels are inversely correlated with serum infliximab levels. In patients hospitalized for severe ulcerative colitis and treated with high-dose infliximab, we predict that early serum infliximab levels (24, 48, and 72 hour) will be positively associated with clinical response and avoidance of colectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis (UC), Inflammatory Bowel Disease
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 29, 2013
Enrollment StartNov 1, 2013
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.7 years ago

Interventions

Infliximabdrug

All patients meeting inclusion criteria will receive the infliximab 10mg/kg IV as part of standard care of the hospitalized patient with severe ulcerative colitis at UCSF Medical Center.