Actively Recruiting
Rituximab and Ocrelizumab in Serum With Multiple Sclerosis (ROS-MS): Personalized Treatment Study in Relapsing-Remitting MS
Led by Haukeland University Hospital · Updated on 2024-10-29
60
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
H
Haukeland University Hospital
Lead Sponsor
U
University of Bergen
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates personalized treatment options using rituximab and ocrelizumab for patients with relapsing-remitting multiple sclerosis (RRMS) diagnosed within the last year. It is a substudy of the larger OVERLORD-MS trial, aiming to see if rituximab is as effective and safe as ocrelizumab in treatment-naïve RRMS patients. The study focuses on how measuring drug levels in the blood might help tailor treatments to individual needs. Participants receive either rituximab or ocrelizumab according to the main study's protocol. Blood samples are taken at specific times before and after infusions to measure the serum concentrations of these drugs using advanced laboratory methods called liquid chromatography tandem mass spectrometry (LC-MS/MS). This helps researchers understand how the drugs behave in the body and relate these levels to treatment outcomes. During the study, participants will provide blood samples at scheduled visits up to 24 weeks, covering one treatment cycle with infusions every six months. Researchers will analyze these samples alongside clinical data to explore the relationship between drug levels, biochemical markers, and patient responses. This approach aims to improve treatment personalization and monitoring in RRMS.
CONDITIONS
Brief Title
Rituximab and Ocrelizumab in Serum With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be included in the OVERLORD-MS study (NCT04578639)
- Willing to attend laboratory visits for blood sample collection at scheduled times
You will not qualify if you...
- Not willing to attend laboratory visits for blood sample collection at scheduled times
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks during one treatment cycle
Participants provide blood samples for pharmacokinetic measurements before, shortly after infusion, and at multiple time points up to 24 weeks during one treatment cycle.
Visits for blood sample collection at baseline, shortly after infusion, and at 2, 4, 8, 12, and 24 weeks
Trial Site Locations
Total: 1 location
1
Haukeland University Hospital, Deparment of medical biochemistry and pharmacology
Bergen, Vestland, Norway, 5021
Actively Recruiting
Research Team
T
Trond T. Serkland, M.D.
S
Silje Skrede, M.D., PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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