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Ocrelizumab for Early Multiple Sclerosis (IMPACT MS Trial)
IMPACT MS Trial Summary
This trial will test if ocrelizumab can prevent or delay MS in people who have just been diagnosed.
IMPACT MS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowIMPACT MS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.IMPACT MS Trial Design
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Who is running the clinical trial?
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- I have not been treated for latent or active tuberculosis.I had my first MS-like symptoms and an MRI showing inactive lesions within the last 90 days.You currently have a hepatitis C virus infection.I am HIV positive.I agree to use effective birth control or remain abstinent during and after the study.I have been diagnosed with high-risk clinically isolated syndrome or relapsing MS.You are very sensitive or allergic to the trial medications.I am between 18 and 50 years old.I have not taken any medication to modify my MS.I haven't taken corticosteroids in the last 7 days.You have had a serious allergic reaction to monoclonal antibodies in the past.I have an active hepatitis B infection.I am not pregnant or have been sterilized if I am of childbearing age.I can walk without aid or rest for at least 500 meters.My first demyelinating event is not due to MS but another condition.I cannot or should not have an MRI.My MS is getting worse over time.
- Group 1: Observational study cohort
- Group 2: Ocrelizumab treated
- 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
How many individuals have been invited to participate in this investigation?
"Affirmative. Data hosted on clinicaltrials.gov indicates that this medical experiment, which was initially published on August 30th 2020, is actively recruiting participants. Approximately 30 volunteers need to be recruited from 1 distinct clinic."
Has the FDA greenlit Ocrelizumab for therapeutic usage?
"Considering the Phase 4 status of Ocrelizumab, our team at Power judged its safety to be high and rated it a 3."
Are there any current opportunities to join this trial?
"Affirmative. Clinicaltrials.gov reflects that this study, which first appeared on August 30th 2020, is actively recruiting patients. Approximately 30 participants will be sourced from a single medical center."
Does this experimental research allow enrollees who are over fifty years of age?
"According to the parameters of this research, only individuals aged between 18 and 50 may apply."
What are the qualifications a person must possess to be considered eligible for this clinical trial?
"To qualify for entry into this research trial, participants must have an MS diagnosis and be aged between 18-50. As of now, 30 individuals are being enrolled in the study."
Does this trial represent a pioneering approach to medicine?
"Since 2008, Ocrelizumab treated has been subject to extensive study. The initial research was funded by Genentech, Inc., and featured 220 participants. Despite an early approval at the Phase 2 stage of development, there are still currently 29 active trials spanning 321 cities and 60 nations that aim to further investigate its efficacy."
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