MS treatment gets personal: could tailored infusions be just as effective?
NCT ID NCT05296161
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares the standard fixed-interval dosing of ocrelizumab (every 24 weeks) with a personalized approach where infusions are given only when B cell levels rise above a certain threshold. The goal is to see if the personalized schedule is just as good at preventing relapses and new brain lesions, while potentially reducing side effects and costs. The trial involves 296 adults with relapsing-remitting MS who have already been on ocrelizumab for at least a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ocrelizumab (Ocrevus)
- What this could lead to
- If successful, this could lead to a more personalized, safer, and cheaper way to manage relapsing-remitting MS by tailoring infusion intervals to each patient's immune response.
- What could go wrong
- This is a Phase 4 trial, so the drug is already approved. The main question is whether personalized dosing is as effective as standard dosing; there is a small risk of increased disease activity if intervals are extended too far.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 296 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2022
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Amsterdam UMC, location VU
Amsterdam, North Holland, 1081 HV, Netherlands
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