Examining personalized treatment for multiple sclerosis with rituximab and ocrelizumab
Rituximab and Ocrelizumab in Serum With Multiple Sclerosis (ROS-MS)
Haukeland University Hospital · NCT06663111
This study is testing whether measuring the levels of two different medications, rituximab and ocrelizumab, can help doctors personalize treatment for people with relapsing-remitting multiple sclerosis who are just starting therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Haukeland University Hospital (other) |
| Drugs / interventions | rituximab, ocrelizumab |
| Locations | 1 site (Bergen, Vestland) |
| Trial ID | NCT06663111 on ClinicalTrials.gov |
What this trial studies
This observational study, known as ROS-MS, is a pharmacological substudy of the OVERLORD-MS study, which investigates the efficacy and safety of rituximab compared to ocrelizumab in treatment-naïve patients with relapsing-remitting multiple sclerosis. The study will quantify serum concentrations of both medications using advanced liquid chromatography tandem mass spectrometry at specific intervals. By analyzing these concentrations alongside biochemical parameters, researchers aim to explore the potential for personalized treatment approaches through therapeutic drug monitoring and pharmacokinetic-pharmacodynamic models. The overarching goal is to enhance treatment outcomes for patients with this condition.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with relapsing-remitting multiple sclerosis within the last 12 months who are participating in the OVERLORD-MS study.
Not a fit: Patients who are not willing to attend laboratory visits for blood sample collection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with relapsing-remitting multiple sclerosis.
How similar studies have performed: Other studies have shown promise in using therapeutic drug monitoring and pharmacokinetic models for personalized treatment, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bergen, Vestland
- Haukeland University Hospital, Deparment of medical biochemistry and pharmacology — Bergen, Vestland, Norway (RECRUITING)
Study contacts
- Principal investigator: Trond T. Serkland, M.D. — Haukeland University Hospital
- Study coordinator: Trond T. Serkland, M.D.
- Email: trond.tretteberg.serkland@helse-bergen.no
- Phone: 004755975563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Relapsing Remitting Multiple Sclerosis