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| Name | Class |
|---|---|
| Onze Lieve Vrouwe Gasthuis | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golimumab | Patients who are eligible for golimumab therapy. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients eligible for inclusion are patients (either outpatient or hospitalized) with moderate to severe UC refractory to corticosteroids and immunomodulators.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pleun S. van Egmond, MSc | Contact | 0205663874 | p.s.vanegmond@amc.nl | |
| Hanke Brandse, drs | Contact | 0205667805 | j.f.brandse@amc.nl |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze Lieve Vrouwe Gasthuis | Recruiting | Amsterdam | North Holland | 1091AC | Netherlands |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 30, 2019 | |
| Reset | Jul 26, 2019 | |
| Release | Jul 31, 2019 | |
| Reset | Sep 6, 2019 | |
| Release | Sep 10, 2019 | |
| Reset | Oct 2, 2019 | |
| Release | Oct 9, 2019 | |
| Reset | Oct 30, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 30, 2019 | Jul 26, 2019 | |||
| Jul 31, 2019 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Stool samples and blood samples.
| 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 |
| Ron Mathot, Phd | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Academic Medical Center | Recruiting | Amsterdam | North Holland | 1100 DD | Netherlands |
|
| Sep 6, 2019 |
| Sep 10, 2019 | Oct 2, 2019 |
| Oct 9, 2019 | Oct 30, 2019 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |