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Monoclonal Antibodies
Ocrelizumab for Progressive Multiple Sclerosis (CONSONANCE Trial)
Moscow, Russian Federation
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
EDSS (Expanded Disability Status Scale) </ =6.5 at screening
Be older than 18 years old
Must not have
Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks
Participants in a severely immunocompromised state until the condition resolves
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 96, week 96 to week 192 and baseline to week 192
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new MS treatment to see if it is effective and safe.
See full description
Who is the study for?
This trial is for adults with Progressive Multiple Sclerosis (PMS) who've had disability progression in the last 2 years, can use a smartphone with Wi-Fi, and have an EDSS score of 6.5 or less. Women must agree to contraception during treatment and afterward. Exclusions include recent other MS treatments, severe immune conditions, certain drug intolerances, active infections, pregnancy, or previous ocrelizumab use.Check my eligibility
What is being tested?
The study tests Ocrelizumab's effectiveness and safety in treating PMS. It's an open-label trial where all participants receive the drug; there are no comparison groups. The focus is on how well it works over time and what side effects occur.See study design
What are the potential side effects?
Ocrelizumab may cause infusion reactions like itching or rash, infections due to weakened immunity, potential liver issues indicated by blood tests changes. There might also be a risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk with assistance or devices.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken azathioprine, cyclophosphamide, mycophenolate mofetil, or methotrexate in the last 3 months.
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My immune system is currently not severely weakened.
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I have been treated with ocrelizumab before.
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I do not have good veins for IV access.
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I am currently being treated or monitored for cancer recurrence.
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I cannot tolerate or am not allowed to take corticosteroids.
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I haven't taken daclizumab, ozanimod, or figolimod in the last 8 weeks.
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My condition is relapsing-remitting MS.
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I was treated with natalizumab and PML was not ruled out following a specific procedure.
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I have never had treatment with alemtuzumab, total body irradiation, or bone marrow transplantation.
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I have or had a brain infection called PML.
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I have been diagnosed with a neurological disorder.
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I do not need long-term steroids or immunosuppressants.
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I cannot undergo an MRI scan.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 96, week 96 to week 192 and baseline to week 192
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 96, week 96 to week 192 and baseline to week 192
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Participants with No Evidence of Progression (NEP)
Proportion of Participants with no evidence of progression and no active disease (NEPAD)
Secondary study objectives
Change from Baseline in Patient-Reported Outcomes (PROs)
Measure of phase rim lesions using a Susceptibility-Weighted Imaging [SWI]/T2 sequence
Spectroscopic MR: Measure of the Relative Signal Amplitude of N-Acetyl Aspartate (NAA), and Choline to Creatine
Side effects data
From 2024 Phase 4 trial • 10 Patients • NCT0426179030%
Headache
20%
Cough
10%
Blood pressure fluctuation
10%
Chest discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ocrelizumab
Awards & Highlights
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: OcrelizumabExperimental Treatment1 Intervention
Ocrelizumab will be administered via intravenous (IV) infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
2016
Completed Phase 4
~8850
Find a Location
Closest Location:University of Cincinnati; Department of Neurology· Cincinnati, OH· 100 miles
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,476 Previous Clinical Trials
1,105,059 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
24,938 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,250 Previous Clinical Trials
904,154 Total Patients Enrolled
37 Trials studying Multiple Sclerosis
18,264 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any corticosteroids in the last 4 weeks.I've had treatments targeting B-cells, but not rituximab in the last 6 months, and my B-cell levels are normal.I haven't taken azathioprine, cyclophosphamide, mycophenolate mofetil, or methotrexate in the last 3 months.I received all necessary vaccines at least 6 weeks before starting ocrelizumab, and I avoid live vaccines during treatment.I do not have any severe illnesses that would stop me from joining the study.My immune system is currently not severely weakened.I have been treated with ocrelizumab before.I haven't taken teriflunomide in the last 12 weeks or have undergone a washout procedure.I do not have good veins for IV access.I haven't taken teriflunomide in the last 2 years, or my levels are low.I have not taken siponimod in the last 2 weeks.I have been on a stable dose of MS medication for at least 30 days.I haven't taken mitoxantrone, cyclosporine, or cladribine in the last 96 weeks.I can walk with assistance or devices.I have no active infections, or they have been treated and resolved.I am currently being treated or monitored for cancer recurrence.I cannot tolerate or am not allowed to take corticosteroids.I haven't taken daclizumab, ozanimod, or figolimod in the last 8 weeks.My condition is relapsing-remitting MS.I was treated with natalizumab and PML was not ruled out following a specific procedure.I have never had treatment with alemtuzumab, total body irradiation, or bone marrow transplantation.I have or had a brain infection called PML.I have been diagnosed with a neurological disorder.I have not taken natalizumab in the last 12 weeks.I do not need long-term steroids or immunosuppressants.I cannot undergo an MRI scan.
Research Study Groups:
This trial has the following groups:- Group 1: Ocrelizumab
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.