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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 4.3 years
Awards & highlights
Study 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 belowSelect...
My disability score is between 3 and 6.5.
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My walking test score is 150 seconds or less.
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I have been diagnosed with primary progressive multiple sclerosis.
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I have been diagnosed with primary progressive multiple sclerosis.
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I have difficulty moving my legs.
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I have a mobility issue in my legs that affects my daily activities.
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My disability score is between 3 and 6.5.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to approximately 4.3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 4.3 years
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 moreTrial 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
~5730
Methylprednisolone
2015
Completed Phase 4
~2280
Antihistamine
2016
Completed Phase 3
~220
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,285 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,260 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
887,733 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
17,587 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a bone marrow or stem cell transplant.I meet all specific requirements for ocrelizumab treatment as per my local guidelines.My immune system is weakened.My disability score is between 3 and 6.5.My MS symptoms started less than 10 years ago if my disability score is 5 or less, or less than 15 years ago if my score is over 5.I have not had IV immunoglobulin or plasmapheresis in the last 12 weeks.My walking test score is 150 seconds or less.I have previously been treated with specific drugs like mitoxantrone or alemtuzumab.I cannot have an MRI or use gadolinium.I need long-term steroids or immunosuppressants for another condition.You have a history of or currently have a non-drug-related immune system disorder.I have been diagnosed with primary progressive multiple sclerosis.I have been diagnosed with primary progressive multiple sclerosis.My MS treatment dose has been stable, and I haven't started new treatments or physiotherapy in the last 4 weeks.I am allergic or cannot take certain required medications for infusion reactions.My neurological condition has been stable for at least 30 days.I do not have good veins for IV access.There is proof that you have specific protein bands in your cerebrospinal fluid.I have stopped any previous immune-related treatments for the required time.You have other neurological disorders that might make it difficult to diagnose MS or evaluate the effectiveness and safety of the treatment.My MS treatment dose has been stable, and I haven't started new treatments or physiotherapy in the last 4 weeks.Your average score for a hand dexterity test is up to 250 seconds.I have difficulty moving my legs.I do not have any uncontrolled illnesses that would stop me from joining the study.You have a brain MRI showing signs of multiple sclerosis.I haven't taken fingolimod, siponimod, or ozanimod in the last 6 weeks.I am a woman who cannot become pregnant because I am post-menopausal or have had surgery to prevent pregnancy.I haven't used anti-CD20 drugs in the last 2 years, my B-cell count is normal, and I didn't stop due to side effects or it not working.You have taken any new or experimental medicine or received any experimental treatment for multiple sclerosis.You have had problems with drinking too much alcohol or using drugs in the past year.I have had an organ transplant or received anti-rejection medication.You are allergic or have a bad reaction to any ingredient in ocrelizumab.I have not taken corticosteroids in the last 4 weeks.I have had cancer within the last 10 years.I have or might have had a brain infection called PML.I have not received a live vaccine in the last 6 weeks.I have not taken interferons beta or glatiramer acetate in the last 2 weeks.I have been treated with natalizumab within the last 4.5 months.My condition is either relapsing-remitting or secondary progressive MS.I have not had a serious infection or been treated with strong antibiotics recently.You have a positive test for hepatitis B that is not being properly treated.I have a mobility issue in my legs that affects my daily activities.My disability score is between 3 and 6.5.
Research Study Groups:
This trial has the following groups:- Group 1: Ocrelizumab Higher Dose
- Group 2: Ocrelizumab Approved Dose
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT04548999 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many different research sites is this study taking place?
"In total, 45 medical sites are enrolling patients for this clinical trial. These include the Advanced Neurosciences Institute in Nashville, Tennessee, Alabama Neurology Associates in Homewood, Alabama, MS and Neuromuscular Center of Excellence in Clearwater, Florida, and 42 other locations."
Answered by AI
What are the main conditions that Ocrelizumab is approved to treat?
"Oftentimes, ophthalmia, sympathetic is best treated with Ocrelizumab. This therapeutic intervention can also help patients with lupus erythematosus, temporal arteritis, and scalp structure."
Answered by AI
Is this trial accessible to octogenarians?
"The age bracket for patients that this study is looking to enroll falls between 18-55 years old."
Answered by AI
What are the most comparable clinical trials to the one involving Ocrelizumab?
"There are 177 ongoing clinical trials investigating the efficacy of ocrelizumab. Of these, 52 are in Phase 3. 8697 research sites are running these trials, with a significant number based in Duarte, California."
Answered by AI
If I enroll in this clinical trial, what am I allowed to do?
"Eligible patients for this clinical trial must have a diagnosis of multiple sclerosis and be between 18-55 years old. So far, 699 patients have been recruited."
Answered by AI
Has Ocrelizumab received the okay from the FDA?
"Our team at Power estimates that Ocrelizumab is safe, as it is a Phase 3 trial. This means that there is some data supporting efficacy and multiple rounds of data supporting safety."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Colorado
Tennessee
How old are they?
18 - 65
What site did they apply to?
Washington University School of Medicine
Hotel-Dieu de Levis
Advanced Neurosciences Research LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I have PPMS and currently on a normal Ocrevus schedule and would like to see if an increase in meds might help.
PatientReceived 1 prior treatment
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