Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
Status:
Completed
Trial end date:
2019-09-30
Target enrollment:
Participant gender:
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.