Ulcerative Colitis
Conditions
Keywords
pharmacokinetics, Golimumab, IBD
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).
Interventions
None listed
Sponsors
Onze Lieve Vrouwe Gasthuis
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Contra-indication to golimumab: TBC, severe infections or congestive heart failure. * Imminent need for surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| serum Albumin | day 0,1,4,7,14,18, week 4,6,10,18,30,42,52 | — |
| Endoscopic response | week 10, 52 | defined by improvement in endoscopic Mayo score of at least 1 point |
| Clinical response by SCCAI | week 10, 52 | — |
| Quality of Life by IBDQ, SF-36 | week 10, 52 | — |
| Clearance | day 1,4,7,14,18, week 4,6,10,18,30,42,52 | calculated from primary outcome (concentrations) |
| fecal golimumab levels | day 1,4,7,14,18, week 4,6,8,18,30,42,52 | — |
| serum CRP | day 0,1,4,7,14,18, week 4,6,10,18,30,42,52 | — |
| 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 |
| fecal calprotectin | day 0,1,4,7,14,18, week 4,6,10,18,30,42,52 | — |
Countries
Netherlands
Contacts
Primary ContactPleun S. van Egmond, MSc
Backup ContactHanke Brandse, drs
Outcome results
None listed