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Ofatumumab for Multiple Sclerosis (SOSTOS Trial)
SOSTOS Trial Summary
This trial will test whether relapsing-remitting MS patients who have not had a relapse in the past year would benefit from switching to ofatumumab, and whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from ofatumumab.
SOSTOS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSOSTOS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 3 trial • 319 Patients • NCT02004522SOSTOS Trial Design
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- I have been on a disease-modifying therapy for my RRMS for at least 6 months.My symptoms or MRI results are not caused by multiple sclerosis.My brain or spinal cord issues are caused by another condition, not my current illness.I have symptoms or a diagnosis of PML.I have not had a cancer relapse in the last 6 months.I am between 18 and 45 years old.I have been diagnosed with relapsing-remitting MS according to the 2017 criteria.You are okay with wearing a specific device as described in the study plan.My disability level allows me to walk, at least with assistance.My condition is progressively worsening without relapses.I have another active cancer.I do not have any active infections, including COVID-19, and I am not HIV positive.I have a chronic immune system condition other than MS, being treated.I may have signs of my condition on an MRI, but it's not required for this trial.I haven't used experimental MS drugs in the last 2 years.
- Group 1: Ofatumumab
- Group 2: DMT continued therapy
- 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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 include adult participants that meet the age criteria of 25 or older?
"This medical trial is searching for patients aged between 18 and 50. There are 46 studies recruiting minors, while 405 trials focus on adults that exceed the age of 65."
Is there a history of Ofatumumab being studied in clinical trials?
"Ofatumumab was first studied at the National Institutes of Health Clinical Center in 2010, and since then there have been 72 completed trials. Currently 23 active studies are underway with many centered around Lubbock, Texas."
Are new participants being accepted in this clinical trial?
"Clinicaltrials.gov has it on record that this clinical trial, which was initially posted on March 2nd 2022, is currently searching for candidates and its details were last updated October 10th 2022."
How many people are partaking in this research experiment?
"Affirmative. The information on clinicaltrials.gov illustrates that this experiment is currently recruiting individuals. This research was first posted on March 2nd 2022 and updated lastly on October 10th 2022, with the aim of sourcing 150 subjects from 9 medical facilities."
To what degree can Ofatumumab pose a threat to those receiving it?
"According to our assessment, ofatumumab's safety rating is 3 out of 3 as its approval status denotes multiple rounds of testing and data validation."
Are there any locations in North America conducting the research study?
"Currently, this medical trial is running in 9 distinct locations, which include Lubbock, Birmingham and Cullman. To alleviate the need for travel, it is advantageous to select the closest site when enrolling as a study participant."
Does this experiment represent a pioneering approach to research?
"Internationally, there are 23 ongoing clinical studies related to the drug Ofatumumab. The initial trial commenced a decade ago and was sponsored by GlaxoSmithKline; it involved 32 participants and concluded its Phase 2 assessment successfully. Since then, 72 similar trials have been conducted in 290 cities across 45 countries."
Do I meet all the criterion to participate in this research initiative?
"The trial has 150 slots open for patients between the ages of 18-50 with multiple sclerosis in its acute relapsing stage."
How is Ofatumumab commonly employed in medical treatment?
"Ofatumumab is the typical treatment for multiple sclerosis and has been seen to be useful in managing refractory cases, fludarabine-ineligible patients, and active secondary progressive multiple sclerosis (spms)."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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