Personalized dosing of ocrelizumab for treating relapsing remitting multiple sclerosis
Efficacy, Safety and Cost-effectiveness of B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple Sclerosis: a Randomized Controlled Trial
This study is testing if giving ocrelizumab at personalized times based on how quickly B cells come back can help adults with relapsing remitting multiple sclerosis feel better compared to the standard schedule.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 296 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Drugs / interventions | ocrelizumab, alemtuzumab |
| Locations | 1 site (Amsterdam, Noord-Holland) |
| Trial ID | NCT05296161 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy, safety, and cost-effectiveness of ocrelizumab administered at personalized intervals tailored to individual B cell repopulation rates in patients with relapsing remitting multiple sclerosis (RRMS). The study involves a national multicenter randomized controlled design with a follow-up period of 96 weeks, comparing standard dosing every 24 weeks to a personalized approach. A total of 296 adult patients who have been on ocrelizumab for at least 12 months will be included in the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with relapsing remitting multiple sclerosis who have been treated with ocrelizumab for a minimum of 48 weeks.
Not a fit: Patients who have received previous treatments with alemtuzumab, cladribine, or stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and individualized treatment plans for patients with RRMS.
How similar studies have performed: While personalized dosing approaches have been explored in other contexts, this specific method for ocrelizumab in RRMS is novel and has not been previously tested in a prospective setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A current diagnosis of relapsing remitting multiple sclerosis according to the 2017 McDonald criteria34 * EDSS score of 0 to 6.5 * Treatment with ocrelizumab for a minimum of 48 weeks (two 300 mg infusions and one 600 mg infusion) Exclusion Criteria: * Previous treatment with alemtuzumab, cladribine or stem cell transplantation * Relapse in the past 3 months prior to inclusion * Subsequent treatment with another DMT next to ocrelizumab in the past 6 months prior to inclusion * Inability to undergo regular MRI scanning * Women who are pregnant or expect to become pregnant during the study period
Where this trial is running
Amsterdam, Noord-Holland
- Amsterdam UMC, location VU — Amsterdam, Noord-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Joep Killestein, Prof. — Amsterdam UMC, location VU
- Study coordinator: Laura Hogenboom, Msc
- Email: l.hogenboom1@amsterdamumc.nl
- Phone: 01204440717
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.