The purpose of this study is to gain insights in the pharmacokinetics of golimumab in moderate to severe Ulcerative Colitis after subcutaneous administration, during induction and maintenance treatment the investigators will collect blood and stool samples at different time points.
The pharmacokinetic characteristics of golimumab will be assessed by using blood and stool samples; collected during induction and maintenance treatment Patients will undergo 13-16 blood sample collections, 13-16 stool sample collections and 3 endoscopies during 16 hospital visits in 1 year. They are also asked to fill in a short questionnaire (9x). At endoscopy visits a questionnaire regarding quality of life will be taken.The population pharmacokinetics of golimumab will be assessed using nonlinear mixed-effects modelling (NON-MEM).
Study Type
OBSERVATIONAL
Enrollment
20
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, Netherlands
RECRUITINGAcademic Medical Center
Amsterdam, North Holland, Netherlands
RECRUITINGGolimumab concentrations (peak/trough,AUC)
By measuring golimumab concentrations at different time point during induction and maintenance therapy we can determine pharmacokinetic parameters of golimumab in ulcerative colitis patients.
Time frame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
Development of Golimumab-antibodies
Assessment of neutralizing antidrug-antibodies by radiomimmuno assay
Time frame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
Endoscopic response
defined by improvement in endoscopic Mayo score of at least 1 point
Time frame: week 10, 52
Clinical response by SCCAI
Time frame: week 10, 52
Quality of Life by IBDQ, SF-36
Time frame: week 10, 52
fecal calprotectin
Time frame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
fecal golimumab levels
Time frame: day 1,4,7,14,18, week 4,6,8,18,30,42,52
serum CRP
Time frame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
Clearance
calculated from primary outcome (concentrations)
Time frame: day 1,4,7,14,18, week 4,6,10,18,30,42,52
serum Albumin
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Time frame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52