Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis
Status:
Not yet recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
Partial response or loss of response to golimumab is observed in a significant proportion of
patients started on golimumab for active ulcerative colitis. The current dosing regimen in
European Union is based on patients' body weight as maintenance treatment for patients with ≥
80 kg is 100 mg q4 weeks and for patients with <80 kg 50 mg q4 weeks. The investigators
recent observations in a golimumab pharmacokinetics study of 24 patients however, show large
interindividual variations in golimumab trough concentrations. Furthermore, it seems that
patients with continuous response have higher golimumab trough levels at several time points
during treatment compared to patients who lose response. Higher induction/maintenance dose of
golimumab increases golimumab trough levels, therefore it is likely that higher
induction/maintenance dose of golimumab would increase efficacy of golimumab treatment.