Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis (GO-KINETIC)

July 2, 2015 updated by: Hanke Brandse, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.

Study Overview

Status

Unknown

Conditions

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).

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord Holland
      • Amsterdam, Noord Holland, Netherlands, 1091AC
        • Recruiting
        • Onze Lieve Vrouwe Gasthuis
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeroen Jansen, MD
      • Amsterdam, Noord Holland, Netherlands, 1100 DD
        • Recruiting
        • Academic Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Golimumab
Patients who are eligible for golimumab therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Golimumab concentrations (peak/trough,AUC)
Time Frame: 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.
day 0,1,4,7,14,18, week 4,6,10,18,30,42,52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of Golimumab-antibodies
Time Frame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
Assessment of neutralizing antidrug-antibodies by radiomimmuno assay
day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
Endoscopic response
Time Frame: week 10, 52
defined by improvement in endoscopic Mayo score of at least 1 point
week 10, 52
Clinical response by SCCAI
Time Frame: week 10, 52
week 10, 52
Quality of Life by IBDQ, SF-36
Time Frame: week 10, 52
week 10, 52
fecal calprotectin
Time Frame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
fecal golimumab levels
Time Frame: day 1,4,7,14,18, week 4,6,8,18,30,42,52
day 1,4,7,14,18, week 4,6,8,18,30,42,52
serum CRP
Time Frame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
Clearance
Time Frame: day 1,4,7,14,18, week 4,6,10,18,30,42,52
calculated from primary outcome (concentrations)
day 1,4,7,14,18, week 4,6,10,18,30,42,52
serum Albumin
Time Frame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
day 0,1,4,7,14,18, week 4,6,10,18,30,42,52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Onze Lieve Vrouwe Gasthuis

Investigators

  • Principal Investigator: mark lowenberg, MD, Phd, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Principal Investigator: Geert R D'Haens, MD, Phd, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Principal Investigator: Ron Mathot, Phd, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 29, 2014

Study Record Updates

Last Update Posted (Estimate)

July 3, 2015

Last Update Submitted That Met QC Criteria

July 2, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL48785.018.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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