drugset / Trial / NCT02687724
Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Golimumab | Monoclonal antibody | 50 mg | — |
| Subject | Golimumab | Monoclonal antibody | 100 mg | — |