drugset / Trial / NCT02687724

Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis

NCT02687724

Phase 4 Unknown 136 enrolled University College Dublin
RandomizedParallel-groupOpen-labelTreatment

Summary

GLM dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A nationwide multi-centred randomised controlled trial (RCT) investigating the use of GLM dose adjustment in ulcerative colitis (UC). The primary objective is to ascertain if dose adjustment of GLM based on GLM drug levels and FCP levels results in higher response and remission rates than standard SmPC dosing.

Timeline

Start
2016-06
Primary completion
2020-02
Completion
2020-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Golimumab Monoclonal antibody 50 mg
Subject Golimumab Monoclonal antibody 100 mg

Indications