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Intensive vs Escalation Therapy Approaches for Multiple Sclerosis (DELIVER-MS Trial)
Phase 4
Recruiting
Led By Daniel Ontaneda, MD, MSc
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women aged 18 to 60 years
Participants must be ambulatory with disease onset ≤ 5 years and treatment-naïve (i.e., no MS DMT at any time in the past)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months to 72 months
Awards & highlights
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.
Who is the study for?
This trial is for men and women aged 18 to 60 with Relapsing-Remitting Multiple Sclerosis (RRMS), diagnosed per the latest criteria, who have had active disease recently but haven't taken any MS drugs before. They should be able to walk and have had MS symptoms start within the last five years.Check my eligibility
What is being tested?
The DELIVER-MS study compares two treatment strategies: one starts with strong Disease Modifying Therapies (DMTs) early on, while the other begins with less intense treatments and increases only if needed. The goal is to see which approach leads to better long-term outcomes.See study design
What are the potential side effects?
While specific side effects are not listed here, DMTs can generally cause a range of reactions including flu-like symptoms, injection site reactions, heart problems, liver issues, increased risk of infections or allergic reactions depending on the medication used.
DELIVER-MS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
Select...
I can walk, was diagnosed with my condition less than 5 years ago, and have never taken disease-modifying treatments.
Select...
I have had at least one MS flare-up or new brain/spine lesions in the last 18 months.
Select...
I can walk with a cane for about 20 meters without resting.
Select...
My condition is relapsing-remitting MS according to the 2013 criteria.
DELIVER-MS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months to 72 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months to 72 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain volume loss, baseline to month 36
EDSS+, month 48 to month 72
Secondary outcome measures
Brain volume loss, month 6 to month 36
Change in MSIS-29, baseline to 36 months
Neurosteroids
+4 moreDELIVER-MS Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: ESC: EscalationExperimental Treatment1 Intervention
Participants randomized to the "ESC: Escalation" arm will receive any other approved MS therapy (not one of the EHT group) as their initial disease modifying treatment.
Interventions: one of the MS therapies NOT in the highly effective group
The randomization affects only the INITIAL treatment received. Once that treatment has been initiated, any subsequent changes are made according to standard clinical practice, regardless of randomization group.
Group II: EHT: Early Highly-effectiveExperimental Treatment1 Intervention
Participants randomized to the "EHT: Early Highly-effective" arm will receive one of the highly effective MS therapies (Ocrevus, Lemtrada, Tysabri, Rituximab, Kesimpta) as their initial disease modifying treatment.
Interventions: one of the highly effective MS therapies
The randomization affects only the INITIAL treatment received. Once that treatment has been initiated, any subsequent changes are made according to standard clinical practice, regardless of randomization group.
Group III: OBS: ObservationalActive Control1 Intervention
Participants will not be restricted to a group of MS therapies.
Participants enter this arm if they are not comfortable with randomization, are not eligible to receive any of the options in a randomized arm, or are not able to secure insurance coverage for any therapy in a randomized arm.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,365,276 Total Patients Enrolled
19 Trials studying Multiple Sclerosis
3,348 Patients Enrolled for Multiple Sclerosis
University of NottinghamOTHER
502 Previous Clinical Trials
2,262,057 Total Patients Enrolled
14 Trials studying Multiple Sclerosis
646 Patients Enrolled for Multiple Sclerosis
Daniel Ontaneda, MD, MScPrincipal Investigator - The Cleveland Clinic
Cleveland Clinic Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: OBS: Observational
- Group 2: EHT: Early Highly-effective
- Group 3: ESC: Escalation
Awards:
This trial has 5 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
California
North Carolina
Virginia
Other
How old are they?
18 - 65
What site did they apply to?
University of Buffalo
UTHealth-Houston
What portion of applicants met pre-screening criteria?
Met criteria
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