Relapsing Remitting Multiple Sclerosis
Conditions
Brief summary
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.
Detailed description
OVERLORD-MS is a 30 months prospective randomized double blinded multicenter non-inferiority study. The objective of OVERLORD-MS is to demonstrate if rituximab is non-inferior to ocrelizumab with regards to efficacy and safety in treatment naïve patients with relapsing-remitting multiple sclerosis (RRMS), diagnosed within the last 12 months. 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.
Interventions
OTHERBlood samples for PK
Blood sampled for pharmacokinetic study
Sponsors
University of Bergen
Haukeland University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Included in OVERLORD-MS (NCT04578639) * Willing to attend laboratory for blood sample collection at scheduled time points
Exclusion criteria
\* Not willing to attend laboratory for blood sample collection at scheduled time points
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum drug concentration measured using liquid chromatography tandem mass spectrometry (LC-MS/MS) | Up to 24 weeks (during one cycle of treatment, injection of rituximab or ocrelizumab is scheduled every 6 months) | The serum concentration of rituximab or ocrelizumab after drug infusion (maximum serum concentration (Cmax)) and 2, 4, 8, 12, 24 weeks thereafter. |
Countries
Norway
Contacts
Primary ContactTrond T. Serkland, M.D.
Backup ContactSilje Skrede, M.D., PhD
Outcome results
None listed