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Intensive vs Escalation Therapy Approaches for Multiple Sclerosis (DELIVER-MS Trial)

Phase 4

Waitlist Available

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)

Must not have

Participants with contraindications to all forms of DMT in either of the treatment arms

Participants unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months to 72 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I can walk, was diagnosed with my condition less than 5 years ago, and have never taken disease-modifying treatments.

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I have had at least one MS flare-up or new brain/spine lesions in the last 18 months.

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I can walk with a cane for about 20 meters without resting.

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My condition is relapsing-remitting MS according to the 2013 criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot use any standard disease-modifying treatments due to health reasons.

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I am unable to understand and give consent for treatment.

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I have never taken the specified medications.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months to 72 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain volume loss, baseline to month 36

EDSS+, month 48 to month 72

Secondary study objectives

Brain volume loss, month 6 to month 36

Change in MSIS-29, baseline to 36 months

Neurosteroids

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 8Eligibility criteria met