Rituximab and Ocrelizumab in Serum With Multiple Sclerosis
NCT ID: NCT06663111
Last Updated: 2024-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2021-03-15
2027-12-31
Brief Summary
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Detailed Description
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In the patients enrolled in the clinical pharmacological substudy ROS-MS the serum concentrations of rituximab and ocrelizumab will be quantified using liquid chromatography tandem mass spectrometry (LC MS/MS) at predefined points during the dosing interval. Relevant biochemical parameters will also be analyzed in these samples.
Based on these measurements, the investigators will examine correlations between serum concentrations, biochemical parameters and the clinical outcomes in the OVERLORD-MS study. The objective is to evaluate whether clinical pharmacological tools, such as therapeutic drug monitoring (TDM) and pharmacokinetic pharmacodynamic models (PK-PD models), may be of value in the personalization of treatment with rituximab and ocrelizumab in patients with relapsing-remitting multiple sclerosis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Blood samples for PK
Blood sampled for pharmacokinetic study
Blood samples for PK
Blood samples before, shortly after infusion of already assigned/ongoing treatment as well as after 2, 4, 8, 12, 24 weeks for serum conc. measurements.
Eligibility Criteria
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Inclusion Criteria
* Willing to attend laboratory for blood sample collection at scheduled time points
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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University of Bergen
OTHER
Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Trond T. Serkland, M.D.
Role: PRINCIPAL_INVESTIGATOR
Haukeland University Hospital
Silje Skrede, M.D., PhD
Role: STUDY_DIRECTOR
University of Bergen
Locations
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Haukeland University Hospital, Deparment of medical biochemistry and pharmacology
Bergen, Vestland, Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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228768
Identifier Type: -
Identifier Source: org_study_id
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