A Study to Determine the Effectiveness of Early Intensive vs. Escalation Approach to Treat Relapsing/Remitting Multiple Sclerosis


About this study

The purpose of this study is to determine whether an EHT approach to DMT, defined as use of one of five monoclonal antibodies (alemtuzumab, natalizumab, rituximab, ocrelizumab, ofatumumab) as first-line therapy, is more effective than an escalation of treatment approach in reducing normalized whole brain volume loss measured using MRI in PwRRMS from Baseline to Month 36.

Multi-center pragmatic comparative effectiveness randomized clinical trial with additional-parallel observational cohort.
The DELIVER-MS study seeks to answer the important 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


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Men and women aged 18 to 60 years.
  • Established diagnosis of MS, as defined by the 2017 revision of McDonald Diagnostic Criteria.
  • RRMS disease course as defined by the 2013 revisions of the MS clinical course definition.
  • 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).
  • Participants must be ambulatory with disease onset ≤ 5 years and treatment-naïve (i.e., no MS DMT at any time in the past).
  • Participants must be eligible to receive at least one form of DMT within each treatment arm.
  • EDSS at Baseline visit ≤ 6.5.

Exclusion Criteria:

  • 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, cladribine, siponimod, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, glatiramer acetate, fingolimod, terflunomide, dimethyl fumarate, daclizumab, mitoxantrone.
  • Participants must not have 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 (with the exception of antibodies directed at SARS-CoV-2).
  • 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
  • Participants unable to provide informed consent.
  • Contraindication or inability to undergo MRI with Gd due to metal or metal implants, allergy to Gd contrast, claustrophobia, pain, spasticity, or excessive movement related to tremor.
  • Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that, in the opinion of the PI, is likely to affect the participant's ability to comply with the study protocol.

Eligibility last updated 4/28/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Orhun Kantarci, M.D.

Open for enrollment

Contact information:

Melissa Bush

(507) 538-5418


More information


Publications are currently not available

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