← Back to Search

Monoclonal Antibodies

High-Dose Ocrelizumab for Multiple Sclerosis

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Expanded disability status scale (EDSS) score at screening and baseline, from 3 to 6.5 inclusive
Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds
Must not have
Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
Immunocompromised state
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 4.3 years
Awards & highlights

Summary

This trial will compare the effects of a higher dose of ocrelizumab to the current approved dose in people with PPMS.

Who is the study for?
Adults with Primary Progressive Multiple Sclerosis (PPMS) who have specific MRI brain abnormalities, a stable neurological condition for at least 30 days before the trial, and an EDSS score between 3 to 6.5. Disease duration must be under 10 years for lower EDSS scores or under 15 years for higher scores. Women of childbearing potential must use contraception; those without reproductive potential can also join.Check my eligibility
What is being tested?
The study is testing whether a higher dose of Ocrelizumab given every six months is more effective than the approved standard dose in treating PPMS. It's randomized and double-blind, meaning participants are put into groups by chance and neither they nor the researchers know who gets which dose.See study design
What are the potential side effects?
Ocrelizumab may cause infusion reactions, infections due to weakened immune response, possible reactivation of hepatitis B if previously infected, and increased risk of cancer as seen in some patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My disability score is between 3 and 6.5.
Select...
My walking test score is 150 seconds or less.
Select...
I have been diagnosed with primary progressive multiple sclerosis.
Select...
I have been diagnosed with primary progressive multiple sclerosis.
Select...
I have difficulty moving my legs.
Select...
I have a mobility issue in my legs that affects my daily activities.
Select...
My disability score is between 3 and 6.5.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a bone marrow or stem cell transplant.
Select...
My immune system is weakened.
Select...
I have not had IV immunoglobulin or plasmapheresis in the last 12 weeks.
Select...
I have previously been treated with specific drugs like mitoxantrone or alemtuzumab.
Select...
I cannot have an MRI or use gadolinium.
Select...
I need long-term steroids or immunosuppressants for another condition.
Select...
I am allergic or cannot take certain required medications for infusion reactions.
Select...
I do not have good veins for IV access.
Select...
I have stopped any previous immune-related treatments for the required time.
Select...
I haven't taken fingolimod, siponimod, or ozanimod in the last 6 weeks.
Select...
I have had an organ transplant or received anti-rejection medication.
Select...
I have not taken corticosteroids in the last 4 weeks.
Select...
I have or might have had a brain infection called PML.
Select...
I have been treated with natalizumab within the last 4.5 months.
Select...
My condition is either relapsing-remitting or secondary progressive MS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 4.3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 4.3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to onset of cCDP sustained for at least 12 weeks.
Secondary outcome measures
Annual Rate of Percent Change from Baseline in Total Brain Volume
Change from Baseline in the Anti-Drug Antibody (ADA) Levels
Change in B-cell Levels in Blood
+17 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ocrelizumab Higher DoseExperimental Treatment3 Interventions
Participants will be randomized to receive a minimum of 5 higher treatment doses (1200 mg or 1800 mg) of ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the double blind treatment (DBT) phase. During the optional open-label extension (OLE) phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Group II: Ocrelizumab Approved DoseActive Control3 Interventions
Participants will be randomized to receive a minimum of 5 treatment doses of 600 mg ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the DBT phase. During the optional OLE phase, participants will be offered a higher dose of ocrelizumab (either 1200 or 1800 mg), based on their body weight at OLE baseline, for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
2016
Completed Phase 3
~5770
Methylprednisolone
2015
Completed Phase 4
~2280
Antihistamine
2016
Completed Phase 3
~240

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Multiple Sclerosis (MS) treatments often target the immune system to reduce inflammation and slow disease progression. Ocrelizumab, a monoclonal antibody, depletes B-cells by targeting the CD20 surface marker, which is crucial because B-cells play a significant role in the autoimmune response that damages myelin in MS. This mechanism helps reduce the frequency of relapses and slows the progression of disability. Other common treatments include interferon beta, which modulates the immune response, and glatiramer acetate, which mimics myelin basic protein to divert the immune attack away from myelin. These treatments are essential for MS patients as they help manage symptoms, reduce relapses, and improve quality of life.
Prognostic Markers of Ocrelizumab Effectiveness in Multiple Sclerosis: A Real World Observational Multicenter Study.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,436 Previous Clinical Trials
1,090,866 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,264 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,204 Previous Clinical Trials
889,537 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
17,590 Patients Enrolled for Multiple Sclerosis

Media Library

Ocrelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04548999 — Phase 3
Multiple Sclerosis Research Study Groups: Ocrelizumab Higher Dose, Ocrelizumab Approved Dose
Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT04548999 — Phase 3
Ocrelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04548999 — Phase 3
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT04548999 — Phase 3
~118 spots leftby Apr 2025