Your session is about to expire
← Back to Search
Monoclonal Antibodies
Ocrelizumab for Progressive Multiple Sclerosis (CONSONANCE Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24 to week 96, week 24 to week 192, week 48 to week 192
Awards & highlights
CONSONANCE Trial Summary
This trial is testing a new MS treatment to see if it is effective and safe.
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.
CONSONANCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk with assistance or devices.
CONSONANCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24 to week 96, week 24 to week 192, week 48 to week 192
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24 to week 96, week 24 to week 192, week 48 to week 192
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Participants with No Evidence of Progression (NEP)
Proportion of Participants with no evidence of progression and no active disease (NEPAD)
Secondary outcome measures
Change from Baseline in Cognitive Function, as Measured by Brief Visuospatial Memory Test - Revised (BVMT-R)
Change from Baseline in Cognitive Function, as Measured by the Symbol Digit Modalities Test (SDMT)
Change from Baseline in Patient-Reported Outcomes (PROs)
+23 moreCONSONANCE 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 3
~5730
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,127 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,102 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
887,575 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
17,429 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have there been similar studies to this one in the past?
"Ocrelizumab has had a long history of research and clinical trials, with the first one happening in 2008. A Phase 2 drug approval was received following the first trial involving only 220 patients. As of now, there are 29 active trials being conducted for Ocrelizumab across 321 cities and 60 countries worldwide."
Answered by AI
Is this trial limited to a particular age group?
"As clarified by the study's eligibility requirements, any potential participants must be between 18 and 65 years of age."
Answered by AI
Are there any open slots for new patients in this trial?
"The study referenced is not currently looking for patients, however there are 592 other trials that are. This particular study was posted on 5/28/2018 and updated as recently as 10/26/2022 according to clinicaltrials.gov"
Answered by AI
How can I become a participant of this research?
"This study is looking for 900 participants with multiple sclerosis who are aged 18-65. The most important criteria for candidates are as follows: they must have an EDSS score of 6.5 or less at screening, be able to use a smartphone and connect it to Wi-Fi networks, have documented evidence of disability progression that is not due to relapses in the last 2 years (as judged by their treating physician), and meet at least one of 21 criteria assessing evidence of disability progression that is not due to relapse activity in the last 2 years."
Answered by AI
What are the possible dangers associated with Ocrelizumab?
"Ocrelizumab has been given a safety score of 3 by our team at Power. This is because it is a Phase 3 clinical trial, which means that there is both some evidence of efficacy and multiple rounds of data supporting safety."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger