Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis
GO-KINETIC
1 other identifier
observational
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 17, 2014
CompletedFirst Posted
Study publicly available on registry
October 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedJuly 3, 2015
July 1, 2015
2 years
October 17, 2014
July 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (9)
Development of Golimumab-antibodies
day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
Endoscopic response
week 10, 52
Clinical response by SCCAI
week 10, 52
Quality of Life by IBDQ, SF-36
week 10, 52
fecal calprotectin
day 0,1,4,7,14,18, week 4,6,10,18,30,42,52
- +4 more secondary outcomes
Study Arms (1)
Golimumab
Patients who are eligible for golimumab therapy.
Eligibility Criteria
Patients eligible for inclusion are patients (either outpatient or hospitalized) with moderate to severe UC refractory to corticosteroids and immunomodulators.
You may qualify if:
- 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
You may not qualify if:
- Contra-indication to golimumab: TBC, severe infections or congestive heart failure.
- Imminent need for surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1091AC, Netherlands
Academic Medical Center
Amsterdam, North Holland, 1100 DD, Netherlands
Biospecimen
Stool samples and blood samples.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geert R D'Haens, MD, Phd
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- PRINCIPAL INVESTIGATOR
mark lowenberg, MD, Phd
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- PRINCIPAL INVESTIGATOR
Ron Mathot, Phd
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- drs.
Study Record Dates
First Submitted
October 17, 2014
First Posted
October 29, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
July 3, 2015
Record last verified: 2015-07