Relapsing Remitting Multiple SclerosisROS-MSNCT06663111
Rituximab and Ocrelizumab in Serum With Multiple Sclerosis
An observational study of Relapsing Remitting Multiple Sclerosis, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Blood samples for PK
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 15 Mar 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study 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.
Who may be able to join
- Included in OVERLORD-MS (NCT04578639)
- Willing to attend laboratory for blood sample collection at scheduled time points
Who cannot join
- Not willing to attend laboratory for blood sample collection at scheduled time points
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Silje Skrede, M.D., PhD contact
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital, Deparment of medical biochemistry and pharmacology
Bergen, Vestland, 5021
Trond T. Serkland, M.D., 004755975563, trond.tretteberg.serkland@helse-bergen.no
About this study
Official title: Rituximab and Ocrelizumab in Serum With Multiple Sclerosis (ROS-MS)
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.
Read the 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
- Being tested
- Blood samples for PK
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for PKOther
Blood sampled for pharmacokinetic study
Blood samples for PKOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 weeks (during one cycle of treatment, injection of rituximab or ocrelizumab is scheduled every 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start15 Mar 2021
- Primary completionDec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Trond T. Serkland, M.D., Principal investigator, Haukeland University HospitalSilje Skrede, M.D., PhD, Study director, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663111
- Sponsor's protocol ID
- 228768
- Acronym
- ROS-MS
- Status last verified
- Oct 2024
- First submitted
- 31 Jan 2022
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serkland TT, Oma AF, Hallin EI, Overas MH, Nygaard GO, Myhr KM, Torkildsen O, Roblitz S, Skrede S. Pharmacokinetic-Pharmacodynamic Modelling of Repeated Ocrelizumab Dosing in Relapsing-Remitting Multiple Sclerosis. Clin Pharmacokinet. 2026 Aug 28. doi: 10.1007/s40262-026-01692-8. Online ahead of print.
PubMed 42663866
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab and Ocrelizumab in Serum With Multiple Sclerosis (ROS-MS)
- ClinicalTrials.gov ID
- NCT06663111
- Acronym / sponsor ID
- ROS-MS / 228768
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study 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.
Key inclusion criteria (2 listed)
- Included in OVERLORD-MS (NCT04578639)
- Willing to attend laboratory for blood sample collection at scheduled time points
Key exclusion criteria (1 listed)
- Not willing to attend laboratory for blood sample collection at scheduled time points
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for PKBlood sampled for pharmacokinetic study | Other | – |
| Blood samples for PKBlood samples before, shortly after infusion of already assigned/ongoing treatment as well as after 2, 4, 8, 12, 24 weeks for serum conc. measurements. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Derived from this study: PubMed 42663866Serkland TT, Oma AF, Hallin EI, Overas MH, Nygaard GO, Myhr KM, Torkildsen O, Roblitz S, Skrede S. Pharmacokinetic-Pharmacodynamic Modelling of Repeated Ocrelizumab Dosing in Relapsing-Remitting Multiple Sclerosis. Clin Pharmacokinet. 2026 Aug 28. doi: 10.1007/s40262-026-01692-8. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silje Skrede, M.D., PhD contact
Trond T. Serkland, M.D. principal investigator
Haukeland University Hospital
Silje Skrede, M.D., PhD study director
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trond T. Serkland, M.D. (004755975563, trond.tretteberg.serkland@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06663111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.