Trials / Unknown
UnknownNCT02277470
Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2014-10-29
- Last updated
- 2015-07-03
Locations
2 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02277470. Inclusion in this directory is not an endorsement.