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NCT Number: NCT06663111

Rituximab and Ocrelizumab in Serum With Multiple Sclerosis

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.

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Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital, Deparment of medical biochemistry and pharmacology

Bergen, Vestland, 5021, Norway

Location status: Recruiting

Location contact

Trond T. Serkland, M.D.

CONTACT

[email protected]

004755975563

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood samples for PK

Other

Blood sampled for pharmacokinetic study

Primary outcomes

  1. Serum drug concentration measured using liquid chromatography tandem mass spectrometry (LC-MS/MS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Silje Skrede, M.D., PhD

CONTACT

[email protected]

Trond T. Serkland, M.D.

CONTACT

[email protected]

004755975563

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • University of Bergen

Registry information

Official study title

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

Acronym: ROS-MS

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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