This page shows what was measured, who it was measured in, and what that does not settle.
What Ocrelizumab does in the body
OCREVUS is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults Primary progressive MS, in adults Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more.
From the FDA-approved label: The precise mechanism by which ocrelizumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ocrelizumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.
Why people take it. OCREVUS is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults Primary progressive MS, in adults Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · A10SJL62JY · read 2026-08-29
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 163 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 32 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Energy
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer1 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Energy
modified fatigue impact scale
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
… Waiting for a reviewer
1 registered symptom measure.
— Not recorded
Harms were not a registered measure for this goal.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0
✗ The study did not show it
Who was studied
NCT05269004
How many people
1300
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 Weeks and 48 Weeks as Measured Using Expanded Disability Status Scale (EDSS)
✗ The study did not show it
Who was studied
NCT03085810
How many people
1225
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Time to onset of CDP sustained for at least 24 weeks and for at least 48 weeks
✗ The study did not show it
Who was studied
NCT03599245
How many people
1055
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24
✗ The study did not show it
Who was studied
NCT00406419
How many people
1015
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS
✗ The study did not show it
Who was studied
NCT04035005
How many people
1013
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Time to Onset of Composite 12-week Confirmed Disability Progression (cCDP12)
✗ The study did not show it
Who was studied
NCT04544449
How many people
985
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.2 registered measures of this kind. 3 written-up studies measured this and did not show a benefit.
■What a body can do day to dayEvidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
■Measured performanceEvidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
modified fatigue impact scale
Measured
Things only a test, a scale or a device shows.
area under the concentration time curve
Meaningful
Things that change how a life goes, not only a number.
multiple sclerosis relapse free survival
relapse free
expanded disability status scale
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (27)
american college of rheumatology 20 response at week 24
american college of rheumatology 20 response at week 48
adverse events
american college of rheumatology 20 responses
modified total sharp at week 52
major clinical response
partial clinical response
non responders
who achieved complete renal response
who achieved overall response
american college of rheumatology 20 response
acr20 response
das28 at week 20
adverse events or serious aes
dose limiting toxicity
cortical atrophy 24
thalamic atrophy 12
thalamic atrophy 24
brain volume loss baseline to month 36
edss+ month 48 to month 108
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 26 days
Read from the label, which states: “The terminal elimination half-life was 26 days.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
OCREVUS is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults Primary progressive MS, in adults Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness of OCREVUS have not been established in pediatric patients less than 10 years of age or who weigh less than 25 kg.”
US prescribing information · 9da42362-3bb5-4b83-b4bb-b59fd4e55f0d · read 2026-08-30
On older people, the label states: “Clinical studies of OCREVUS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”
US prescribing information · 9da42362-3bb5-4b83-b4bb-b59fd4e55f0d · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary OCREVUS is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier.”
US prescribing information · 9da42362-3bb5-4b83-b4bb-b59fd4e55f0d · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of ocrelizumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.”
US prescribing information · 9da42362-3bb5-4b83-b4bb-b59fd4e55f0d · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1.
No source is stored against this line.
What is in the pack
Sold as injectable, injection, solution, injection, given by the injection, subcutaneous, intravenous route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Ocrelizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 5075 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
4 products list this as an active ingredient in the United States drug directory. 3 of them contain it and nothing else.
FDA National Drug Code directory · 67643-7001 · read 2026-08-29
They are sold as injection, injection, solution and liquid, taken intravenous and subcutaneous.
FDA National Drug Code directory · 67643-7001 · read 2026-08-29
The regulator's established pharmacologic class for it is antibodies, cd20-directed antibody interactions [moa] and cd20-directed cytolytic antibody [epc].
FDA National Drug Code directory · 67643-7001 · read 2026-08-29
2 published labels name it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · b216af61-99d0-42a3-afc2-b5bf86df1ec0 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · b216af61-99d0-42a3-afc2-b5bf86df1ec0 · read 2026-08-29
OCREVUS is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 300 mg/10 mL (30 mg/mL) clear or slightly opalescent, and colorless to pale brown solution in a single-dose vial., recorded as fda label in effect 2026-05-14 in the United States.
US prescribing information · 9da42362-3bb5-4b83-b4bb-b59fd4e55f0d · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Ocrelizumab studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Ocrelizumab are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Where else this substance is registered
FDA substance identifier (UNII)
A10SJL62JY
RxNorm concept
1876380
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Quoted from a stored source.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S1.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
1 approved application covers products containing this substance. The earliest was BLA761053, approved 20170328 to GENENTECH INC.
This order is fixed in code and does not count clicks or time on the page.
What is not here
5 questions this page could not answer
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Recorded evidence blocks (11)
Q2
What did Ocrelizumab's largest trial (1710 people) and its longest (15 years) measure?
1710 people in Ocrelizumab's largest registered study, 15 years in its longest registered window, measuring Change From Baseline to End of Study in the Physical Functioning Score of the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure… ClinicalTrials.gov · 2026-09-01
36 phase3, 27 na or unstated, 16 phase4, 13 phase2, 6 phase1; NCT00676715; 2023-11-08; no ageing endpoint recorded. Last human test completed 2026, NCT03593590.
Interpretation These counts include studies where Ocrelizumab was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
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phase3
36
na or unstated
27
phase4
16
phase2
13
phase1
6
Last recorded human testNCT03593590
2026-01-19
recorded 2026-09-01 · last checked 2026-09-04
Q3
Ocrelizumab was tested only in human — what did it show?
Interpretation Change From Baseline to End of Study in the Physical Functioning Score of the Patient-Reported Outcome Measure Information System/Quality of Life in… — the recorded outcome words.
Show the evidence
humanNCT06675955
healthspan; Change From Baseline to End of Study in the Physical Functioning Score of the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis 15a (PROMISnq…; 94
recorded 2026-09-01 · last checked 2026-09-04
Q4
16 of Ocrelizumab's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?
futility/efficacy (1), accrual/recruitment (4), funding/business (2) and other (9): Ocrelizumab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA."; 16 of 94 registered studies
Show the evidence
Trial
NCT00406419
terminated; "Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA."
NCT00476996
terminated; "Recruitment was fully completed for this study; however, the study was terminated during conduct after the primary endpoint analysis was completed."
NCT00485589
terminated; "Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA."
NCT00539838
terminated; "The study was terminated prematurely when the decision was made that ocrelizumab was not likely to benefit this patient population."
NCT00626197
terminated; "Study was terminated due to an imbalance of serious and opportunistic infections in the ocrelizumab treated patients versus the placebo arm."
NCT00673920
terminated; "Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA."
10 further recorded trials
NCT00808210
terminated; "Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA."
NCT02720120
terminated; "The overall benefit risk profile of ocrelizumab was not favorable in RA"
NCT03085810
terminated; "The study was terminated earlier as the study sponsor collected sufficient data to perform all analyses as per pre-specified endpoints in the study protocol."
NCT03835728
terminated; "Failed to meet target enrollment and study was discontinued"
NCT04877457
terminated; "Slow enrollment"
NCT04880577
withdrawn; "Funding"
NCT04925557
terminated; "Lack of recruitment"
NCT04971005
terminated; "Lack of recruitment due to low acceptance of the control arm."
NCT05208840
withdrawn; "Due to deterioration of the geopolitical situation and escalation of conflict between Russia and Ukraine ML42302 study was put on hold."
NCT06677710
suspended; "Business Reasons"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Ocrelizumab used ocrelizumabu 50mg — over how long?
5 recorded entries; human; also "ocrelizumabu 50mg", "ocrelizumabu 200mg", "ocrelizumab 500mg"
Show the evidence
human
NCT00779220
ocrelizumabu 50mg
NCT00779220
ocrelizumabu 200mg
NCT00779220
ocrelizumab 500mg
NCT03589105
Ocrelizumab 300 mg
NCT03589105
Ocrelizumab 600 mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Ocrelizumab's half-life is 26 days — which schedules were studied?
26 days, the half-life Ocrelizumab's label states. openfda-label · 9da42362-3bb5-4b83-b4bb-b59fd4e55f0d · 2026-08-30
Show the evidence
half life
26 days; The terminal elimination half-life was 26 days.
metabolism
Metabolism The metabolism of OCREVUS has not been directly studied because antibodies are cleared principally by catabolism.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of acr20 response, adverse events and adverse events or serious aes did Ocrelizumab's trials measure?
acr20 response, adverse events and adverse events or serious aes lead 32 outcome terms across Ocrelizumab's trials. ClinicalTrials.gov · 2026-09-01
american college of rheumatology 20 responses, modified total sharp at week 52, major clinical response, partial clinical response, non responders and who achieved complete renal response follow.
Show the evidence
american college of rheumatology 20 response at week 24
1
american college of rheumatology 20 response at week 48
1
adverse events
1
american college of rheumatology 20 responses
1
modified total sharp at week 52
1
major clinical response
1
14 more recorded rows
partial clinical response
1
non responders
1
who achieved complete renal response
1
who achieved overall response
1
american college of rheumatology 20 response
1
acr20 response
1
das28 at week 20
1
adverse events or serious aes
1
dose limiting toxicity
1
cortical atrophy 24
1
thalamic atrophy 12
1
thalamic atrophy 24
1
brain volume loss baseline to month 36
1
edss+ month 48 to month 108
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Ocrelizumab's 34 ongoing trials reports first?
Proportion of patients with no evidence of disease activity (NEDA, as defined per protocol).; Proportion of Participants with No Evidence of Progression (NEP); latest 2032-02-25
Show the evidence
Trial
NCT03477500
"Randomized Autologous heMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab for RRMS (RAM-MS)"; n 100; "Proportion of patients with no evidence of disease activity (NEDA, as defined per protocol)."; 2028-03-21
NCT03523858
"A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis"; n 927; "Proportion of Participants with No Evidence of Progression (NEP)"; 2026-10-22
NCT03535298
"Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS"; n 800; "Brain volume loss, baseline to month 36"; 2027-07-30
NCT04035005
"A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis"; n 1013; "Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS"; 2028-01-19
NCT04047628
"Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)"; n 156; "Multiple Sclerosis (MS) Relapse-Free Survival"; 2029-10
NCT04075266
"A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis"; n 23; "Dose Exploration Period: Area Under the Concentration Versus Time Curve of Ocrelizumab"; 2029-12-01
14 further recorded trials
NCT04387734
"Effects of Ocrevus in Relapsing Multiple Sclerosis"; n 60; "Dynamic Gait Stability"; 2026-09-30
NCT04466150
"Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset"; n 30; "Comparison of intrathecal synthesis of gammaglobulins in treatment-naïve relapsing MS and clinically isolated syndrome participants before and after treatment with ocrelizumab"; 2027-07
NCT04544436
"A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)"; n 864; "Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12)"; 2028-08-31
NCT04544449
"A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis"; n 985; "Time to Onset of Composite 12-week Confirmed Disability Progression (cCDP12)"; 2027-07-21
NCT04548999
"A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)"; n 769; "Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12)"; 2027-09-08
NCT04578639
"Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS Disease"; n 214; "Proportion without new MRI activity"; 2025-09-14
NCT04688788
"Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis"; n 600; "Percentage of patients without new or enlarging T2 white matter lesions on brain MRI scans"; 2029-06-10
NCT05123703
"A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)"; n 188; "Protocol-defined Annualized Relapse Rate (ARR)"; 2029-09-17
NCT05210621
"LONG-TERM EFFECTIVENESS AND SAFETY EVALUATION OF OCRELIZUMAB"; n 72; "Proportion of patients with upper limb disability progression"; 2029-02-24
NCT05269004
"A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis"; n 1300; "Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0"; 2027-12-31
NCT05285891
"Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis"; n 123; "Absence of clinical relapse"; 2032-02-25
NCT05296161
"B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple Sclerosis"; n 296; "Confirmed relapse-free patients"; 2027-03
NCT05688436
"A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies"; n 1178; "Number of Major Congenital Malformations (MCMs)"; 2031-01-17
NCT05906992
"A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis"; n 512; "Area under the concentration-time curve in PK group"; 2029-01
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Ocrelizumab could settle lifespan?
NCT04047628 measures Multiple Sclerosis (MS) Relapse-Free Survival, reading out 2029-10.
2 open trials; n 156; "Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)"
Show the evidence
Trial
NCT04047628
"Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)"; n 156; "Multiple Sclerosis (MS) Relapse-Free Survival"; 2029-10
NCT06675955
"An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment"; n 500; "Change From Baseline to End of Study in the Physical Functioning Score of the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis 15a (PROMISnq…"; 2029-12-31
Q10
Which 15 trials of Ocrelizumab posted no result?
Posted no result
15 of 15 completed trials
Registrations
NCT00077870, NCT02723071, NCT03589105, NCT04966338, NCT04676555 and NCT03025269, and 9 more
Completion dates
oldest 2006-12; newest 2024-02-28
Show the evidence
Trial
NCT00077870
2006-12
NCT02723071
2008-01
NCT03589105
2021-02-15
NCT04966338
2021-10-01
NCT04676555
2021-10-21
NCT03025269
2022-01-08
9 further recorded trials
NCT04387110
2022-03-01
NCT04855617
2022-10-01
NCT04459988
2022-10-25
NCT05627271
2023-04-20
NCT05131984
2023-07-01
NCT05081700
2023-11-03
NCT03873389
2023-12-05
NCT05974852
2023-12-30
NCT05974839
2024-02-28
Q11
At the median, Ocrelizumab's trials enrolled 152 people — anything larger?
Median enrolment
152
Largest enrolment
1710
Registered trials counted
93
Q12
What do 5075 spontaneous reports say about Ocrelizumab — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Ocrelizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 5075 reaction mentions were counted: covid-19 1300; urinary tract infection 797; infusion related reaction 602; multiple sclerosis relapse 440. open-targets-adr · CHEMBL2108041 · 2026-06-24
Show the evidence
covid-19
1300
urinary tract infection
797
infusion related reaction
602
multiple sclerosis relapse
440
throat irritation
382
multiple sclerosis
373
4 more recorded rows
nasopharyngitis
373
herpes zoster
371
influenza
257
oral herpes
180
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 8 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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