Status:
UNKNOWN
Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Onze Lieve Vrouwe Gasthuis
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
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 treatmen...
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 collec...
Eligibility Criteria
Inclusion
- 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
- Contra-indication to golimumab: TBC, severe infections or congestive heart failure.
- Imminent need for surgery
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02277470
Start Date
August 1 2014
End Date
August 1 2016
Last Update
July 3 2015
Active Locations (2)
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1
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, Netherlands, 1091AC
2
Academic Medical Center
Amsterdam, North Holland, Netherlands, 1100 DD