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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Ulcerative Colitis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Golimumab<br>Patients who are eligible for golimumab therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Endoscopic response | defined by improvement in endoscopic Mayo score of at least 1 point | 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 | 
| fecal golimumab levels |  | day 1,4,7,14,18, week 4,6,8,18,30,42,52 | 
| serum CRP |  | day 0,1,4,7,14,18, week 4,6,10,18,30,42,52 | 
| Clearance | calculated from primary outcome (concentrations) | day 1,4,7,14,18, week 4,6,10,18,30,42,52 | 
| serum Albumin |  | day 0,1,4,7,14,18, week 4,6,10,18,30,42,52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, Golimumab, IBD