Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT02277470
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Age from 18 years, either male or female
- Moderate to severe UC (according to Mayo score (2 or 3) baseline endoscopy), both anti-TNF naïve and anti-TNF exposed patients will be included
- Baseline endoscopy
- Obtained written informed consent
- Contra-indication to golimumab: TBC, severe infections or congestive heart failure.
- Imminent need for surgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Golimumab concentrations (peak/trough,AUC) day 0,1,4,7,14,18, week 4,6,10,18,30,42,52 By measuring golimumab concentrations at different time point during induction and maintenance therapy we can determine pharmacokinetic parameters of golimumab in ulcerative colitis patients.
- Secondary Outcome Measures
Name Time Method fecal golimumab levels day 1,4,7,14,18, week 4,6,8,18,30,42,52 serum Albumin day 0,1,4,7,14,18, week 4,6,10,18,30,42,52 Quality of Life by IBDQ, SF-36 week 10, 52 fecal calprotectin day 0,1,4,7,14,18, week 4,6,10,18,30,42,52 Clinical response by SCCAI week 10, 52 Development of Golimumab-antibodies day 0,1,4,7,14,18, week 4,6,10,18,30,42,52 Assessment of neutralizing antidrug-antibodies by radiomimmuno assay
Clearance day 1,4,7,14,18, week 4,6,10,18,30,42,52 calculated from primary outcome (concentrations)
Endoscopic response week 10, 52 defined by improvement in endoscopic Mayo score of at least 1 point
serum CRP day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
Trial Locations
- Locations (2)
Academic Medical Center
🇳🇱Amsterdam, Noord Holland, Netherlands
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Noord Holland, Netherlands