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High-Dose Ocrelizumab for Multiple Sclerosis
Study Summary
This trial is testing a higher dose of ocrelizumab, given every 24 weeks, to see if it is more effective than the current 600 mg dose, in people with RMS. The trial will also look at safety and how the body processes the drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I need long-term steroids or immunosuppressants for another health issue.My disability level is moderate or less.I haven't taken fingolimod, siponimod, or ozanimod in the last 6 weeks.I have or might have had a brain infection called PML.I meet the safety guidelines for ocrelizumab as per its label.I cannot have an MRI or use contrast dye due to health reasons.My MS treatment dose has been stable, and I haven't started new treatments or physiotherapy in the last 4 weeks.I do not have any neurological disorders that could affect MS diagnosis or treatment assessment.I have not taken interferons beta or glatiramer acetate in the last 2 weeks.I can walk 25 feet in 150 seconds or less, on average.I have not had a major infection or been on strong antibiotics recently.I have used anti-CD20 drugs before, but under specific conditions.I have had cancer within the last 10 years.I have been diagnosed with primary progressive multiple sclerosis.I have not received a live vaccine in the last 6 weeks.I have not had a break from certain medications before starting this trial.I have taken natalizumab within the last 4.5 months.I have been diagnosed with relapsing multiple sclerosis.My immune system is weakened.I have had an organ transplant or received anti-rejection medication.I have not taken systemic corticosteroids in the last 4 weeks.I am a woman who cannot become pregnant because I am post-menopausal or have had surgery to prevent pregnancy.I have not had IV immunoglobulin or plasmapheresis in the last 12 weeks.I do not have any severe illnesses that would stop me from joining the study.I have had a bone marrow or stem cell transplant.I have not had any changes in my neurological condition for at least 30 days.I've had at least 2 relapses in the last 2 years or 1 in the last year with none in the last 30 days.
- Group 1: Ocrelizumab Approved Dose
- Group 2: Ocrelizumab Higher Dose
- 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.
- 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
Is this clinical trial open to people who are less than 25 years old?
"In order to take part in this study, potential trial participants must fall within the age bracket of 18 to 55 years old. There are 78 other trials for those under 18 and 540 for seniors above 65."
Could you please tell me if Ocrelizumab has been used in other research studies?
"The first clinical trial for ocrelizumab was completed in 2003 at Penn State Hershey Cancer Institute. As of now, a total of 313 have been completed with 180 more ongoing. There is a high concentration of these active trials taking place in Alexandria, Louisiana."
Are there still patients being accepted for this research project?
"Yes, this is an active recruitment clinical trial that was first posted on 11/26/2020. The most recent update was on 11/8/2022 and the study is looking for 786 participants total from 11 different locations."
Who does this trial require as participants?
"This study is recruiting 786 patients with multiple sclerosis who are between the ages of 18 and 55. Patients must also meet the following criteria: they must be neurologically stable for at least 30 days prior to being randomized into the study, they must have had at least two documented clinical relapses in the last 2 years or one relapse in the year prior to screening, they cannot have had a relapse in the 30 days prior to screening or at baseline, they cannot have started any new symptomatic treatment for MS or physiotherapy within 4 weeks of being randomized, their average T25FWT score over two trials at screening and over two"
How many sites are running this clinical trial?
"Currently, 11 clinical trial sites are running this study. Some notable locations include The NeuroMedical Clinic of Central Louisiana in Alexandria, Stanford University Medical Center and Stanford Neuroscience Health Center in Cullman, and North Central Neurology Associates in Cullman."
How many subjects are enrolling in this experiment?
"That is correct. The clinicaltrials.gov website has the most recent information on this study, which was posted on November 26th, 2020 and updated on November 8th, 2020. This study is looking to recruit 786 patients from 11 different locations."
What is the official government stance on Ocrelizumab?
"There is both efficacy and safety data available for Ocrelizumab from Phase 3 clinical trials, thus it receives a score of 3."
For what medical purpose is Ocrelizumab most often given to patients?
"Ocrelizumab is the standard care medication for treating ophthalmia, sympathetic. Additionally, it can also help manage scalp structure, temporal arteritis, and lupus erythematosus."
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