Clinical trial NCT02277470: Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis
Official title: Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Keywords: pharmacokinetics, Golimumab, IBD
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Onze Lieve Vrouwe Gasthuis
First posted: 2014-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients eligible for inclusion are patients (either outpatient or hospitalized) with moderate to severe UC refractory to corticosteroids and immunomodulators.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Golimumab concentrations (peak/trough,AUC)
timeFrame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
Secondary outcomes:
measure: Development of Golimumab-antibodies
timeFrame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
measure: Endoscopic response
timeFrame: week 10, 52
measure: Clinical response by SCCAI
timeFrame: week 10, 52
measure: Quality of Life by IBDQ, SF-36
timeFrame: week 10, 52
measure: fecal calprotectin
timeFrame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
measure: fecal golimumab levels
timeFrame: day 1,4,7,14,18, week 4,6,8,18,30,42,52
measure: serum CRP
timeFrame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
measure: Clearance
timeFrame: day 1,4,7,14,18, week 4,6,10,18,30,42,52
measure: serum Albumin
timeFrame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Geert R D'Haens, MD, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: mark lowenberg, MD, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Ron Mathot, Phd
role: PRINCIPAL_INVESTIGATOR
References: