Suspended

DELIVER-MSDetermining the Effectiveness of earLy Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis

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What is being tested

Early Highly Effective Therapies Group

+ Escalation Therapies Group

Drug
Who is being recruted

Autoimmune Diseases+5

+ Demyelinating Diseases

+ Immune System Diseases

From 18 to 60 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2019
See protocol details

Summary

Principal SponsorThe Cleveland Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 3, 2019

Actual date on which the first participant was enrolled.

The DELIVER-MS study seeks to answer the question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. The study results will help guide overall treatment philosophy and will be applicable not only to a wide range of existing therapies but also to new therapies, meeting a significant unmet need in patient decision making and aiding the decision for medication approval by third parties.

Official TitleDetermining the Effectiveness of earLy Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis
NCT03535298
Principal SponsorThe Cleveland Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

800 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDemyelinating DiseasesImmune System DiseasesMultiple SclerosisNervous System DiseasesAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNSMultiple Sclerosis, Relapsing-Remitting

Criteria

7 inclusion criteria required to participate
Men and women aged 18 to 60 years.
Established diagnosis of MS, as defined by the 2017 revision of McDonald Diagnostic Criteria (99).
RRMS disease course as defined by the 2013 revisions of the MS clinical course definition (4).
Participants must have evidence of active disease based on: one or more MS relapses within the last 18 months prior to screening visit or radiological evidence of MS activity (≥2 new T2 lesions within the last 12 months from screening [compared to a previous recent MRI within 18 months of screening] or ≥1 GdE demonstrated on brain or spinal cord MRI performed within the last 12 months of screening).
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7 exclusion criteria prevent from participating
Participants with contraindications to all forms of DMT in either of the treatment arms.
Participants must never have received any of the following medications: natalizumab, alemtuzumab, ocrelizumab, rituximab, ofatumumab, cladribine, siponimod, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate, daclizumab, mitoxantrone, diroximel fumarate, ozanimod, monomethyl fumarate, ponesimod.
Participants must have not received any of the following medications, for reasons other than MS, in the last 12 months: cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, leflunomide, laquinimod, atacicept, other monoclonal antibodies.
Participants with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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 II

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 30 locations

Suspended

University of Colorado-Anschutz Medical Campus

Aurora, United StatesOpen University of Colorado-Anschutz Medical Campus in Google Maps
Suspended

University of Minnesota

Minneapolis, United States
Suspended

Mayo Clinic

Rochester, United States
Suspended

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, United States
Suspended30 Study Centers