Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— GO-KINETIC  

Official title:

Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02277470
• Other study ID #: NL48785.018.14
• Status: Recruiting
• Phase: N/A
• First received: October 17, 2014
• Last updated: July 2, 2015
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: July 2015
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Pleun S. van Egmond, MSc
• Phone: 0205663874
• Email: p.s.vanegmond[@]amc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord Holland
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam	Noord Holland

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Onze Lieve Vrouwe Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Golimumab concentrations (peak/trough,AUC)	By measuring golimumab concentrations at different time point during induction and maintenance therapy we can determine pharmacokinetic parameters of golimumab in ulcerative colitis patients.	day 0,1,4,7,14,18, week 4,6,10,18,30,42,52	No
Secondary	Development of Golimumab-antibodies	Assessment of neutralizing antidrug-antibodies by radiomimmuno assay	day 0,1,4,7,14,18, week 4,6,10,18,30,42,52	No
Secondary	Endoscopic response	defined by improvement in endoscopic Mayo score of at least 1 point	week 10, 52	No
Secondary	Clinical response by SCCAI		week 10, 52	No
Secondary	Quality of Life by IBDQ, SF-36		week 10, 52	No
Secondary	fecal calprotectin		day 0,1,4,7,14,18, week 4,6,10,18,30,42,52	No
Secondary	fecal golimumab levels		day 1,4,7,14,18, week 4,6,8,18,30,42,52	No
Secondary	serum CRP		day 0,1,4,7,14,18, week 4,6,10,18,30,42,52	No
Secondary	Clearance	calculated from primary outcome (concentrations)	day 1,4,7,14,18, week 4,6,10,18,30,42,52	No
Secondary	serum Albumin		day 0,1,4,7,14,18, week 4,6,10,18,30,42,52	No