CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 112 enrolled
Drug / intervention
Golimumabdrug
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/NCT03124121
NCT03124121Phase 4Completed
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Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels

Guy's and St Thomas' NHS Foundation Trust·interventional·Posted Apr 21, 2017·Updated Jul 6, 2021

In Brief

A Phase 4 clinical trial evaluating Golimumab for Ulcerative Colitis. Completed, enrolled 112 participants across 1 site.

Detailed Summary

The purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe Ulcerative Colitis (UC). Patients commencing induction therapy with golimumab will be enrolled into a prospective study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC disease activity as well as serum golimumab concentrations and the presence of anti-golimumab antibodies. Patients already established on stable golimumab maintenance therapy will be enrolled into a cross-sectional study with the same evaluations taken at a single time point.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesUnited Kingdom
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 21, 2017
Enrollment StartSep 5, 2017
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.2 years ago

Interventions

Golimumabdrug

A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha