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

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ClinicalTrials.gov Identifier: NCT02277470
Recruitment Status : Unknown
Verified July 2015 by Hanke Brandse, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Recruiting
First Posted : October 29, 2014
Last Update Posted : July 3, 2015
Sponsor:
Collaborator:
Onze Lieve Vrouwe Gasthuis
Information provided by (Responsible Party):
Hanke Brandse, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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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.

Condition or disease
Ulcerative Colitis

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 Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis
Study Start Date : August 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Golimumab

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Endoscopic response [ Time Frame: week 10, 52 ]
    defined by improvement in endoscopic Mayo score of at least 1 point

  3. Clinical response by SCCAI [ Time Frame: week 10, 52 ]
  4. Quality of Life by IBDQ, SF-36 [ Time Frame: week 10, 52 ]
  5. fecal calprotectin [ Time Frame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52 ]
  6. fecal golimumab levels [ Time Frame: day 1,4,7,14,18, week 4,6,8,18,30,42,52 ]
  7. serum CRP [ Time Frame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52 ]
  8. Clearance [ Time Frame: day 1,4,7,14,18, week 4,6,10,18,30,42,52 ]
    calculated from primary outcome (concentrations)

  9. serum Albumin [ Time Frame: day 0,1,4,7,14,18, week 4,6,10,18,30,42,52 ]

Biospecimen Retention:   Samples With DNA
Stool samples and blood samples.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277470


Contacts
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Contact: Pleun S. van Egmond, MSc 0205663874 p.s.vanegmond@amc.nl
Contact: Hanke Brandse, drs 0205667805 j.f.brandse@amc.nl

Locations
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Netherlands
Onze Lieve Vrouwe Gasthuis Recruiting
Amsterdam, Noord Holland, Netherlands, 1091AC
Contact: Pleun S. van Egmond, MSc    020-5663874    p.s.vanegmond@amc.nl   
Contact: Toos Schakel    020-5992214    T.G.Schakel-vandenBerge@olvg.nl   
Principal Investigator: Jeroen Jansen, MD         
Academic Medical Center Recruiting
Amsterdam, Noord Holland, Netherlands, 1100 DD
Contact: Pleun S. van Egmond, MSc    020-5663874    p.s.vanegmond@amc.nl   
Contact: Hanke Brandse, Drs    020-5667850    j.f.brandse@amc.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Onze Lieve Vrouwe Gasthuis
Investigators
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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)
More Information
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Responsible Party: Hanke Brandse, drs., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02277470    
Other Study ID Numbers: NL48785.018.14
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015
Keywords provided by Hanke Brandse, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
pharmacokinetics, Golimumab, IBD
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases