An observational study in Ulcerative Colitis, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Status unknown at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-03.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
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).
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's planned enrollment of 20 is below the median of 105 across 247 observational studies indexed under Colitis.
Browse Colitis studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients eligible for inclusion are patients (either outpatient or hospitalized) with moderate to severe UC refractory to corticosteroids and immunomodulators.
Exclusion Criteria:
Patients who are eligible for golimumab therapy.
Golimumab 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
Time frame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)