Rituximab and Ocrelizumab in Serum With Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorHaukeland University Hospital
About this trial
ROS-MS is a clinical pharmacological substudy to the OVERLORD-MS study (NCT04578639), designed to examine the possibilities of personalized treatment with rituximab and ocrelizumab in patients with relapsing-remitting multiple sclerosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Included in OVERLORD-MS (NCT04578639)
Willing to attend laboratory for blood sample collection at scheduled time points
Disqualifiers
None
Trial population
In OVERLORD-MS, treatment-naïve male and female patients aged 18-60 years, with newly diagnosed multiple sclerosis, are randomized 2:1 to treatment with rituximab or ocrelizumab. In the sub-study ROS-MS, patients are recruited from the patients included i OVERLORD-MS.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood samples for PK
Other interventionBlood sampled for pharmacokinetic study
Blood samples for PK
Other interventionBlood samples before, shortly after infusion of already assigned/ongoing treatment as well as after 2, 4, 8, 12, 24 weeks for serum conc. measurements.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Serum drug concentration measured using liquid chromatography tandem mass spectrometry (LC-MS/MS)
The serum concentration of rituximab or ocrelizumab after drug infusion (maximum serum concentration (Cmax)) and 2, 4, 8, 12, 24 weeks thereafter.
Time frame
Up to 24 weeks (during one cycle of treatment, injection of rituximab or ocrelizumab is scheduled every 6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Haukeland University Hospital
Lead sponsor
University of Bergen
Collaborator
Source ClinicalTrials.gov