NCT06663111

Rituximab and Ocrelizumab in Serum With Multiple Sclerosis

Rituximab and Ocrelizumab in Serum With Multiple Sclerosis (ROS-MS)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Blood samples for PK	Blood sampled for pharmacokinetic study
OTHER	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.

Timeline

• Start date: 2021-03-15
• Primary completion: 2025-12-01
• Completion: 2027-12-31
• First posted: 2024-10-29
• Last updated: 2024-10-29

Locations

1 site across 1 country: Norway