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Intensive vs Escalation Therapy Approaches for Multiple Sclerosis (DELIVER-MS Trial)
DELIVER-MS Trial Summary
This trial is studying whether starting a highly effective disease-modifying therapy early on in people with MS can improve their prognosis.
DELIVER-MS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDELIVER-MS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DELIVER-MS Trial Design
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Who is running the clinical trial?
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- I am between 18 and 60 years old.I can walk, was diagnosed with my condition less than 5 years ago, and have never taken disease-modifying treatments.I am eligible for at least one type of disease-modifying treatment.I cannot use any standard disease-modifying treatments due to health reasons.I am unable to understand and give consent for treatment.I have had at least one MS flare-up or new brain/spine lesions in the last 18 months.I can walk with a cane for about 20 meters without resting.My condition is relapsing-remitting MS as per the 2013 guidelines.I haven't taken the specified medications for non-MS reasons in the past year.My condition is relapsing-remitting MS according to the 2013 criteria.I can walk, was diagnosed with MS within the last 5 years, and have never taken MS drugs.I am eligible for at least one type of disease-modifying treatment.I am between 18 and 60 years old.I have never taken the specified medications.
- Group 1: OBS: Observational
- Group 2: EHT: Early Highly-effective
- Group 3: ESC: Escalation
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Has the Early Highly Effective Therapies Group been recognized by the FDA?
"As this is a phase 4 trial, indicating that the Early Highly Effective Therapies Group has been officially approved for use; our team at Power assesses its safety to be rated 3 on a scale of 1-3."
How can I register for this trial?
"In order to be eligible for this clinical trial, applicants must have multiple sclerosis (acute relapsing) and range in age from 18-60 years old. 800 participants are needed in total."
To which conditions is the Early Highly Effective Therapies Group commonly applied?
"Early Highly Effective Therapies Group is generally implemented to ameliorate the effects of multiple sclerosis, though it has also proven efficacious in treating b-cell lymphomas, polyangium, and crohn disease."
Are there numerous sites hosting this research program in the state?
"Currently, 15 healthcare locations are offering this clinical trial - amongst them being Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, University of Colorado-Anschutz Medical Campus in Aurora, and the University of Minnesota in Minneapolis."
What past experiments has the Early Highly Effective Therapies Group conducted?
"In 1993, the Early Highly Effective Therapies Group was initially investigated at National Institutes of Health Clinical Center. Since then, 1451 trials have been completed and 559 are currently ongoing with many in Las Vegas, Nevada."
Does the protocol for this research permit adults aged 25 and above to participate?
"This clinical trial is open to individuals aged 18 and up, but they must be younger than 60 years old."
How many participants have joined this research endeavor?
"This trial requires 800 participants that meet the requisites of inclusion. Potential candidates can join this medical venture at either Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Nevada or University of Colorado-Anschutz Medical Campus in Aurora, Colorado."
Does this experiment currently have open enrollment?
"Clinicaltrials.gov documentation confirms that this clinical trial, which was initially published on the 3rd of January 2019, is currently recruiting participants. It has been updated as recently as July 22nd 2022."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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