Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 60
Updated:2/2/2019
Start Date:January 3, 2019
End Date:September 2023
Contact:Sarah Planchon Pope, PhD
Email:planchs@ccf.org
Phone:216-636-1232

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

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.


Inclusion Criteria:

1. Men and women aged 18 to 60 years.

2. Established diagnosis of MS, as defined by the 2017 revision of McDonald Diagnostic
Criteria (99).

3. RRMS disease course as defined by the 2013 revisions of the MS clinical course
definition (4).

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).

5. Participants must be ambulatory with disease onset ≤ 5 years and treatment-naïve
(i.e., no MS DMT at any time in the past).

6. Participants must be eligible to receive at least one form of DMT within each
treatment arm.

7. EDSS at Baseline visit ≤ 6.5

Exclusion Criteria:

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

2. Participants must never have received any of the following medications: natalizumab,
alemtuzumab, ocrelizumab, rituximab, cladribine, interferon beta-1a, interferon
beta-1b, pegylated interferon beta-1a, glatiramer acetate, fingolimod, teriflunomide,
dimethyl fumarate, daclizumab, mitoxantrone.

3. 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.

4. 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

5. Participants unable to provide informed consent.

6. 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.

7. 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.
We found this trial at
2
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Daniel Ontaneda, MD, MSc
Phone: 216-445-6724
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Nottingham,
Principal Investigator: Nikos Evangelou, MD, DPhil
Phone: +44 115 9249924
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