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Ublituximab for Multiple Sclerosis (ENHANCE Trial)
ENHANCE Trial Summary
This trial will study how well a new drug, ublituximab, maintains effectiveness after switching from a current anti-CD20 treatment for Multiple Sclerosis.
ENHANCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowENHANCE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ENHANCE Trial Design
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Who is running the clinical trial?
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- I haven't received any live vaccines in the last 4 weeks.My condition is either PPMS or inactive SPMS.I have or had hepatitis B or C, but if C, my PCR test for the virus is negative.My condition worsened after anti-CD20 therapy, shown by recent MRI and/or clinical assessments.I have had a serious unusual infection before.I have or might have a brain infection known as PML.I have been diagnosed with RMS according to the latest criteria.My neurological condition has been stable for over a month.I have a chronic immune system condition other than MS, or an immunodeficiency syndrome.I do not have any long-term infections requiring ongoing treatment.I have never taken ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab for any condition.I am currently being treated with ocrelizumab, rituximab, or ofatumumab.My disability level allows me to walk without aid or rest for 200 meters.I have had a severe reaction to previous anti-CD20 therapy.I have no active cancer except for treated skin cancer or in situ carcinoma.My condition worsened again less than a year ago.I needed IVIG treatment for low immunoglobulins in the last year.
- Group 1: Ublituximab
- 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
Are geriatric patients given access to this experimental research?
"This medical trial is welcoming patients between 18 and 65 years of age."
Is enrollment available for this clinical trial?
"Per clinicaltrials.gov, this trial is actively enrolling patients; the protocol was first made available on May 1st 2023 and has since been revised as of May 18th 2023."
Who can be accepted into this clinical investigation?
"In order to be enrolled in this medical trial, a patient must have multiple sclerosis and occupy the age range of 18 - 65. Currently, there are 300 spots available for participation."
How many individuals are actively participating in this medical experiment?
"Affirmative. According to the clinicaltrials.gov platform, this experiment is actively recruiting participants since being posted on May 1st 2023 and last updated 18 days later. The study intends to enroll 300 patients across two locations."
Has the FDA sanctioned ublituximab for human use?
"There is prior clinical evidence proving Ublituximab's safety, thus assigning it a rating of 3."
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