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Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels — GO-LEVEL  

Ulcerative Colitis Clinical Trial

Official title:
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels

Clinical Trial 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.

Clinical Trial Description

The study will involve two study groups designed to offer insights into the pharmacokinetics of golimumab during induction and maintenance therapy: Cohort 1: Patients commencing golimumab induction therapy will be included in a prospective, observational study. Cohort 2: Patients receiving golimumab maintenance therapy will be included in a cross-sectional, observational study. Primary objective: To define a week 6 serum golimumab concentration that predicts response at week 14. Secondary objective: To define serum golimumab concentrations at weeks 6, 10 and 14 that predict response at each time point, respectively and at week 14. Exploratory objectives: Correlations between serum golimumab concentrations and novel disease activity indices (PRO2), biochemical markers of disease activity (CRP, faecal calprotectin) and quality of life indices (IBD-Q and IBD-Control). Correlations between the presence of anti-golimumab antibodies, serum golimumab concentrations and UC disease activity. This study will also generate data that can be used to validate a commercially available golimumab assay as well as a novel patient reported outcome (PRO) assessment of clinical UC disease activity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03124121
Study type Interventional
Source Guy's and St Thomas' NHS Foundation Trust
Contact
Status Completed
Phase Phase 4
Start date September 5, 2017
Completion date September 30, 2019
View Details
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