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Ocrevus for Multiple Sclerosis (MOBILE-RMS Trial)
MOBILE-RMS Trial 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.
MOBILE-RMS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMOBILE-RMS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MOBILE-RMS Trial Design
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- 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.
- Group 1: Ocrevus
- Group 2: Other Disease Modifying Treatments
- 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.
- 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
Does this research accept participants aged under eighty?
"As evidenced by the eligibility criteria, this trial is limited to those aged 18-65. Alternatively, there are 45 studies available for minors and an additional 402 trials that cater to elderly participants."
What are the qualifications necessary to take part in this experiment?
"This clinical trial seeks 60 individuals, between the ages of majority and retirement age, who have a confirmed diagnosis of relapsing multiple sclerosis. Moreover, participants must satisfy additional prerequisites to be eligible for inclusion: capacity to give written consent; no existing neurological conditions or recent musculoskeletal injuries; ability to stroll 25 feet independently with or without assistive devices (or an Expanded Disability Status Scale score ranging from 1-6.5); capacity to stand unassisted for at least 30 seconds; not pregnant during screening nor throughout the study period; can interpret English language text accurately; no substantial cognitive impairment."
Are there any openings left in this clinical trial?
"Yes, the information posted on clinicaltrials.gov confirms that this medical trial is actively seeking 60 participants between two different sites. The study was first made available to patients at the beginning of February 2021 and had its most recent update in late September 2022."
Has this research been previously conducted or is it a pioneering endeavor?
"Currently, Ocrelizumab has 29 active clinical trials being conducted in 321 cities and 60 countries. Genentech, Inc. first introduced this drug to study over a decade ago with Phase 2 approval from 220 participants. Since its inception in 2008, there have been 10 completed studies on the subject matter."
How efficacious is Ocrelizumab for humans in terms of safety?
"As this is a Phase 4 trial, indicating that the drug Ocrelizumab has been approved for use, our team at Power gave it an overall safety rating of 3."
How many participants have enrolled in this research initiative?
"Affirmative. The study's details on clinicaltrials.gov support that the trial is currently enrolling individuals, which was initiated on 5th February 2021 and most recently updated on 25th September 2022. This investigation requires 60 volunteers split between 2 medical facilities."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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