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Ocrelizumab for Relapsing Multiple Sclerosis
Study Summary
This trial is testing a new MS drug in black and Latino patients to see if it's effective and safe. Around 150 people will be enrolled, and half of them will also have their spinal fluid tested.
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?
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- My neurological condition has been stable for at least 30 days.I do not have any current infections.I have been diagnosed with Primary Progressive Multiple Sclerosis.I have RMS and can still walk without aid or rest for 200 meters.I haven't received any live or inactivated vaccines in the last 6 weeks.My MS has been progressing without relapses for over a year.I am starting or have switched once or twice from specific MS treatments.My condition is related to cancer.I agree to avoid pregnancy or use birth control during and 6 months after ocrelizumab treatment.
- Group 1: All Participants
- 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
Is Ocrelizumab deemed a secure treatment for patients?
"Due to its approval status, Ocrelizumab's safety is rated a 3 on our evaluation scale. This rating indicates that the drug has completed Phase 4 of clinical trials."
Does this experiment currently accept enrollment of participants?
"Clinicaltrials.gov states that this research trial is currently not enrolling any new participants; it was uploaded on July 30th 2020 and edited september 12th 2022, but there are 578 other trials in progress at the moment."
Who has the opportunity to participate in this research endeavor?
"This clinical trial is looking to enrol 150 individuals suffering from multiple sclerosis, between the ages of 18 and 65. Additionally, eligible candidates must self-identify as Black or African American or Hispanic/Latino American; have a diagnosis of RMS with an EDSS score no higher than 5.5 at enrollment; be new to treatment (or switching away from certain disease modifying therapies); and remain neurologically stable for 30 days before randomization and baseline assessments. Moreover, female participants must agree to avoid sexual intercourse or utilize accepted contraceptive methods during the study period plus 6 months following their final dose of ocrelizumab if they"
Does this medical research include participants aged eighty or above?
"As indicated by the requirements for inclusion, study participants must fall within an age range of 18 to 65 years. Alternatively, there are 45 studies that target minors and a further 402 trials designed specifically for people over the age of 65."
Is this experimental procedure a pioneering venture?
"Ocrelizumab was first tested in 2008 under the sponsorship of Genentech, Inc. which included 220 participants. This initial trial resulted in Phase 2 approval for Ocrelizumab and today there are 29 live studies taking place over 321 cities and 60 countries worldwide."
What additional investigations have been conducted involving Ocrelizumab?
"Ocrelizumab was first studied in 2008 at CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge and has since been a subject of 10 completed clinical trials. Presently, 29 distinct studies are actively enrolment patients with numerous locations situated within the Dallas area of Texas."
How many healthcare facilities have been enlisted for this trial's implementation?
"This clinical trial has 34 recruitment sites, such as the MS Treatment Center of Dallas in Dallas, Guilford Neurologic Associates in Greensboro, and Center for Neurology and Spine - Phoenix - Hunt - PPDS in Phoenix."
How extensive is the enrollment for this research project?
"Regrettably, this particular study is not actively seeking participants at the moment. It was initially registered on July 30th 2020 and further modified as recently as September 12th 2022. If you are interested in engaging with other clinical trials, there are 549 medical studies for multiple sclerosis and 29 investigations utilising Ocrelizumab that currently require patient recruitment."
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