Multiple Sclerosis, Relapsing-RemittingPhase 4BLOOMSNCT05296161
B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple Sclerosis
A Phase 4 study testing Ocrelizumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Rationale: B-cell depleting therapies like ocrelizumab are very effective in the treatment of relapsing remitting multiple sclerosis (RRMS). As B cell repopulation varies extensively between individuals (ranging from 27-175 weeks), using a treatment scheme with a fixed infusion interval may be suboptimal. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Ocrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Apr 2022to Mar 2027
- Phase
- Phase 4
- 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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, location VU
Amsterdam, North Holland, 1081 HV
About this study
Official title: Efficacy, Safety and Cost-effectiveness of B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple Sclerosis: a Randomized Controlled Trial
Rationale: B-cell depleting therapies like ocrelizumab are very effective in the treatment of relapsing remitting multiple sclerosis (RRMS). As B cell repopulation varies extensively between individuals (ranging from 27-175 weeks), using a treatment scheme with a fixed infusion interval may be suboptimal. So far personalized adapted treatment of ocrelizumab in RRMS has not been studied in a prospective setting.
Objective: Evaluating the efficacy, safety and cost-effectiveness of ocrelizumab when administered in personalized B cell tailored intervals in RRMS patients.
Read more
Study design: This is a national multicenter randomized controlled trial with 96 week follow-up.
Study population: The study population consists of 296 adult RRMS patients who have received ocrelizumab treatment for a minimum of 12 months (2x 300 mg infusion and 1x 600mg infusion).
Intervention: Patients will be randomized into the standard interval group (600 mg infusions every 24 weeks) or the personalized interval group in which the infusions will be extended as long as the serum CD19 B cell count is below 10 CD19 cells/µL, determined every 4 weeks.
Main study parameters: To conclude non-inferiority of personalized B cell tailored ocrelizumab there will be two co-primary endpoints: 1. the difference of percentage of confirmed relapse-free patients between the two groups after 96 weeks and 2. the difference of percentage of patients free from new/enlarging T2 lesions on MRI between the two groups after 96 weeks. Secondary study parameters are number of confirmed relapses, annualized relapse rate, number of new T2 lesions and brain atrophy on MRI, disability progression, no evidence of disease activity (NEDA), MS disease biomarkers (serum neurofilament light), quality of life, burden of treatment, immunoglobulin levels and (serious) adverse events including occurrence of infections and COVID-19. Furthermore, various immune cell subsets will be studied in relation to ocrelizumab concentration in a subgroup.
Nature and extent of the burden and risks: All patients will be subjected to visits every 24 weeks including clinical scoring and questionnaires. Blood samples and MRI scans will be taken and performed every 48 weeks. Continuous assessment of key stroke dynamics on the patients smartphone and monthly digital cognitive test and walk test will be performed in most patients. As CD19 B cells are kept near complete depletion, the estimated risk of recurrence of disease activity is very low.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Ocrelizumab
- Keywords
- ocrevus, ocrelizumab, personalised dosing
- 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.
OcrelizumabDrug
Also called ocrevus
Personalized B cell tailored ocrelizumab treatment
| Study group | Role | What they receive |
|---|---|---|
| Standard interval dosing | No intervention | The standard group will receive ocrelizumab every 24 weeks following the current label. |
| Personalized B cell tailored ocrelizumab treatment | Experimental | The personalized group will start with B cell measurements 24 weeks after the last infusion (baseline). The infusion interval will never be shorter than 24 weeks. The personalized group will start the study with a possible extension of the interval. The infusion will be postponed as long as CD19 B cell count stays below 10 cells/µL (determined every 4 weeks). When CD19 B cell count exceeds or is equal to 10 cells/µL, ocrelizumab infusion will be scheduled within two weeks Receives: Drug: Ocrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed relapse-free patients
Difference of percentage of confirmed relapse-free patients between the two treatment groups after 96 weeks follow-up.
Measured: 96 weeks
Change of T2 lesions on brain MR
Difference of percentage of patients without new/enlarging T2 MRI lesions between the two treatment groups after 96 weeks follow-up.
Measured: 96 weeks
Secondary outcomes (15)
Annualized relapse rate
Clinical relapses during B-cell tailored dosing
Measured: Baseline, year 1, year 2
Total number of active (new and/or enlarging) T2 lesions on brain MRI
In comparison to the baseline MRI and number of active MRI scans.
Measured: Baseline, year 1, year 2
Disability progression during follow-up
Disability progression measured on the Expanded Disability Status Scale (EDSS)
Measured: Baseline, 6 months,12 months, 18 months, 24 months
Disability progression during follow-up
Disability progression measured on the Expanded Disability Status Scale (EDSS)
Measured: Baseline, year 1, year 2
Brain atrophy
Rate of brain atrophy comparing baseline MRI and MRI at 96 weeks.
Measured: Baseline, year 1, year 2
NEDA (no evidence of disease activity)
NEDA is defined as absence of confirmed relapses, MRI disease activity (new/enlarging T2 lesions) and confirmed disability progression.
Measured: 96 weeks
Change of neurofilament light
Measured in serum
Measured: 96 weeks
Change of quality of life
Measured by the Multiple Sclerosis Impact Scale (MSIS-29)
Measured: Baseline, year 1, year 2
Change of burden of treatment
measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
Measured: Baseline, year 1, year 2
Ocrelizumab wearing-off effect
Presence of a possible wearing-off effect measured by a questionnaire developed by the Amsterdam MS Center
Measured: Baseline, year 1, year 2
IgG levels
Change of IgG levels
Measured: Baseline, year 1, year 2
Cost analysis
Cost-utility analysis using EuroQol 5D (EQ-5D)
Measured: 96 weeks
Disability progression: decrease of hand mobility
Significant decrease of hand mobility measured by an app that analyses key stroke dynamics. The dynamics are measured continuously and analysed every 6 months.
Measured: Baseline, 6 months,12 months, 18 months, 24 months
Disability progression: two minute walking distance
Significant decrease of walking distance measured by an app that analyses distance using GPS signal. The test is taken monthly and analysed every 6 months.
Measured: Baseline, 6 months,12 months, 18 months, 24 months
Disability progression: cognitive impairment
Significant decrease of cognitive impairment measured by an app that is validated for a digital Symbol Digit Modalities Test (SDMT). The test is taken monthly and analysed every 6 months.
Measured: Baseline, 6 months,12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start20 Apr 2022
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter randomized controlled non-inferiority trial in The Netherlands
- Masking
- None (open label)
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoé van Kempen, Amsterdam UMC, location VUmc
- Investigators
- Joep Killestein, Prof., Principal investigator, Amsterdam UMC, location VU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296161
- Sponsor's protocol ID
- 2021.0639
- Acronym
- BLOOMS
- Status last verified
- Jun 2026
- First submitted
- 18 Feb 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Cost-effectiveness of B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple Sclerosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05296161
- Acronym / sponsor ID
- BLOOMS / 2021.0639
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- ocrevus, ocrelizumab, personalised dosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 25 Mar 2022 (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.
Rationale: B-cell depleting therapies like ocrelizumab are very effective in the treatment of relapsing remitting multiple sclerosis (RRMS). As B cell repopulation varies extensively between individuals (ranging from 27-175 weeks), using a treatment scheme with a fixed infusion interval may be suboptimal. So far personalized adapted treatment of ocrelizumab in RRMS has not been studied in a prospective setting.
Objective: Evaluating the efficacy, safety and cost-effectiveness of ocrelizumab when administered in personalized B cell tailored intervals in RRMS patients.
Study design: This is a national multicenter randomized controlled trial with 96 week follow-up.
Study population: The study population consists of 296 adult RRMS patients who have received ocrelizumab treatment for a minimum of 12 months (2x 300 mg infusion and 1x 600mg infusion).
Intervention: Patients will be randomized into the standard interval group (600 mg infusions every 24 weeks) or the personalized interval group in which the infusions will be extended as long as the serum CD19 B cell count is below 10 CD19 cells/µL, determined every 4 weeks.
Main study parameters: To conclude non-inferiority of personalized B cell tailored ocrelizumab there will be two co-primary endpoints: 1. the difference of percentage of confirmed relapse-free patients between the two groups after 96 weeks and 2. the difference of percentage of patients free from new/enlarging T2 lesions on MRI between the two groups after 96 weeks. Secondary study parameters are number of confirmed relapses, annualized relapse rate, number of new T2 lesions and brain atrophy on MRI, disability progression, no evidence of disease activity (NEDA), MS disease biomarkers (serum neurofilament light), quality of life, burden of treatment, immunoglobulin levels and (serious) adverse events including occurrence of infections and COVID-19. Furthermore, various immune cell subsets will be studied in relation to ocrelizumab concentration in a subgroup.
Nature and extent of the burden and risks: All patients will be subjected to visits every 24 weeks including clinical scoring and questionnaires. Blood samples and MRI scans will be taken and performed every 48 weeks. Continuous assessment of key stroke dynamics on the patients smartphone and monthly digital cognitive test and walk test will be performed in most patients. As CD19 B cells are kept near complete depletion, the estimated risk of recurrence of disease activity is very low.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter randomized controlled non-inferiority trial in The Netherlands
| Arm | Type | Receives |
|---|---|---|
| Standard interval dosing | No intervention | –The standard group will receive ocrelizumab every 24 weeks following the current label. |
| Personalized B cell tailored ocrelizumab treatment | Experimental | Drug: OcrelizumabThe personalized group will start with B cell measurements 24 weeks after the last infusion (baseline). The infusion interval will never be shorter than 24 weeks. The personalized group will start the study with a possible extension of the interval. The infusion will be postponed as long as CD19 B cell count stays below 10 cells/µL (determined every 4 weeks). When CD19 B cell count exceeds or is equal to 10 cells/µL, ocrelizumab infusion will be scheduled within two weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| OcrelizumabAlso: ocrevusPersonalized B cell tailored ocrelizumab treatment | Drug | Personalized B cell tailored ocrelizumab treatment |
Primary outcome
Confirmed relapse-free patients
Time frame: 96 weeks
Difference of percentage of confirmed relapse-free patients between the two treatment groups after 96 weeks follow-up.
Change of T2 lesions on brain MR
Time frame: 96 weeks
Difference of percentage of patients without new/enlarging T2 MRI lesions between the two treatment groups after 96 weeks follow-up.
15 secondary outcomes
Annualized relapse rate
Time frame: Baseline, year 1, year 2
Total number of active (new and/or enlarging) T2 lesions on brain MRI
Time frame: Baseline, year 1, year 2
Disability progression during follow-up
Time frame: Baseline, 6 months,12 months, 18 months, 24 months
Disability progression during follow-up
Time frame: Baseline, year 1, year 2
Brain atrophy
Time frame: Baseline, year 1, year 2
NEDA (no evidence of disease activity)
Time frame: 96 weeks
Change of neurofilament light
Time frame: 96 weeks
Change of quality of life
Time frame: Baseline, year 1, year 2
Change of burden of treatment
Time frame: Baseline, year 1, year 2
Ocrelizumab wearing-off effect
Time frame: Baseline, year 1, year 2
IgG levels
Time frame: Baseline, year 1, year 2
Cost analysis
Time frame: 96 weeks
Disability progression: decrease of hand mobility
Time frame: Baseline, 6 months,12 months, 18 months, 24 months
Disability progression: two minute walking distance
Time frame: Baseline, 6 months,12 months, 18 months, 24 months
Disability progression: cognitive impairment
Time frame: Baseline, 6 months,12 months, 18 months, 24 months
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 10 Jun 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Joep Killestein, Prof. principal investigator
Amsterdam UMC, location VU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ocrelizumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed relapse-free patients (time frame: 96 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2026.