Rituximab and Ocrelizumab in Serum With Multiple Sclerosis
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Registration Number
- NCT06663111
- Lead Sponsor
- Haukeland University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Haukeland University Hospital, Deparment of medical biochemistry and pharmacology
🇳🇴Bergen, Vestland, Norway