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Monoclonal Antibodies
Ocrevus for Multiple Sclerosis (MOBILE-RMS Trial)
Phase 4
Waitlist Available
Led By Feng Yang, PhD
Research Sponsored by Georgia State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Can walk at least 25 feet independently with or without assistive device at screening (or the Expanded Disability Status Scale between 1 and 6.5)
No other neurological conditions and recent musculoskeletal injuries
Must not have
History of progressive multifocal leukoencephalopathy (PML)
Treatment with intravenous immunoglobulin within 12 weeks prior to baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial will test if the drug Ocrevus can help improve walking for people with relapsing multiple sclerosis, compared to other existing treatments. 60 people will be split into two groups and receive either Ocrevus or the standard existing treatment (Platform) for one year. Their progress will be measured via walking tests and MRI brain scans, taken at regular intervals.
Who is the study for?
This trial is for adults aged 18-65 with relapsing multiple sclerosis who can walk at least 25 feet and stand for 30 seconds. They must not be pregnant, have no other neurological or severe medical conditions, no recent surgeries or broken bones, and cannot be on certain medications like systemic corticosteroids.
What is being tested?
The study tests if Ocrevus improves walking in people with RMS compared to other Disease Modifying Treatments over a year. Participants will receive either Ocrevus or another DMT and their walking ability and brain health (via MRI) will be monitored regularly.
What are the potential side effects?
Ocrevus may cause infusion reactions, infections due to weakened immune system, potential risk of cancers, allergic reactions to the drug's ingredients, liver issues indicated by blood test changes, and possibly low immunoglobulin levels which could affect infection resistance.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk at least 25 feet on my own, with or without help from a device.
Select...
I do not have any neurological conditions or recent injuries to my muscles or bones.
Select...
I have been diagnosed with active, relapsing MS.
Select...
I can stand on my own for at least 30 seconds.
Select...
I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had progressive multifocal leukoencephalopathy in the past.
Select...
I have not had IV immunoglobulin treatment in the last 3 months.
Select...
I cannot walk 25 feet or stand for 30 seconds on my own.
Select...
I am experiencing severe depression or have thoughts of harming myself.
Select...
I have a history of or currently have a chronic infection like hepatitis or HIV.
Select...
I need long-term steroids or immunosuppressants for another health issue.
Select...
I have an active hepatitis B infection.
Select...
I do not have any active infections, except for fungal infections of my nail beds.
Select...
My lung condition is not regularly checked by a doctor or is unstable.
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I had surgery on my back, hip, shoulder, or a total joint replacement less than 2 years ago.
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I have been treated with B-cell targeted therapies before.
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I have severe heart failure.
Select...
I haven't been hospitalized or needed IV antibiotics in the last 4 weeks, nor oral antibiotics in the last 2 weeks.
Select...
I have had a broken bone in the last year.
Select...
I have been diagnosed with a type of MS called primary-progressive.
Select...
I have not had specific previous treatments like alemtuzumab or bone marrow transplantation.
Select...
I have not taken systemic corticosteroids in the last 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dynamic Gait Stability
Secondary study objectives
Cadence
Expanded Disability Status Scale
Gait speed
+10 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: OcrevusExperimental Treatment1 Intervention
Group II: Other Disease Modifying TreatmentsActive Control1 Intervention
Other Disease Modifying Treatments will consist of FDA-approved injectable and oral medications for multiple sclerosis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
FDA approved
Find a Location
Who is running the clinical trial?
Georgia State UniversityLead Sponsor
62 Previous Clinical Trials
29,024 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
83 Patients Enrolled for Multiple Sclerosis
Multiple Sclerosis Center of AtlantaOTHER
Feng Yang, PhDPrincipal Investigator - Georgia State University
Georgia State University
3 Previous Clinical Trials
108 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
58 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have neurological conditions like Lyme disease or vitamin B12 deficiency that could be confused with MS.I have not received a live vaccine in the last 6 weeks.I can walk at least 25 feet on my own, with or without help from a device.I have had progressive multifocal leukoencephalopathy in the past.I cannot take steroids due to bad reactions or other health issues.Your CD4 count is less than 300 cells per microliter.I have not had IV immunoglobulin treatment in the last 3 months.You have had problems with drinking too much alcohol or using drugs in the past 24 weeks.Your AST/SGOT or ALT/SGPT levels are more than double the normal limit.I cannot walk 25 feet or stand for 30 seconds on my own.I am experiencing severe depression or have thoughts of harming myself.I have a history of or currently have a chronic infection like hepatitis or HIV.My vision problems make it hard for me to walk.Your skin is allergic to clear double-sided tape.You have other serious mental or physical health conditions.I need long-term steroids or immunosuppressants for another health issue.You are allergic to any of the ingredients in ocrelizumab.You cannot have an MRI if you are claustrophobic, weigh more than 140 kg, have a pacemaker, cochlear implants, certain eye conditions, certain types of recent surgeries, or certain recent heart procedures.I have an active hepatitis B infection.I do not have any active infections, except for fungal infections of my nail beds.You have a history of weakened immune system or currently have a weakened immune system.You do not have a vein that can be used for taking blood from your arm.I have received treatments like Botox for neurological conditions in the last 6 months.You have had serious allergic reactions to certain types of medications made from antibodies.My lung condition is not regularly checked by a doctor or is unstable.I do not have any severe illnesses that would stop me from joining the study.You have a history of blood clotting problems or abnormal test results related to blood clotting.Your IgM blood levels are below 0.55 g/L.I had surgery on my back, hip, shoulder, or a total joint replacement less than 2 years ago.I do not have any neurological conditions or recent injuries to my muscles or bones.I have been diagnosed with active, relapsing MS.I have been treated with B-cell targeted therapies before.I have severe heart failure.I have a new or worsening bone condition that is not under control.I haven't been hospitalized or needed IV antibiotics in the last 4 weeks, nor oral antibiotics in the last 2 weeks.Your platelet count is less than 100,000 per microliter.Your blood has low levels of a specific protein called IgG.I have had a broken bone in the last year.I have been diagnosed with a type of MS called primary-progressive.I have not had specific previous treatments like alemtuzumab or bone marrow transplantation.You have trouble with your memory and thinking skills, as shown by a specific test score.Your neutrophil count is less than 1.5 x 103/μL.I can stand on my own for at least 30 seconds.You have a positive result for the rapid plasma reagin (RPR) test.You have a positive pregnancy test at the screening.I have not had a heart attack or heart surgery in the last 6 months.I am between 18 and 65 years old.You have tested positive for hepatitis B or hepatitis C.I have had cancer before, but it was completely removed with surgery.I haven't taken specific immune system medications in the last 2 years.I have not taken systemic corticosteroids in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Ocrevus
- Group 2: Other Disease Modifying Treatments
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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: NCT04387734 — Phase 4
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