Phase
Condition
Scar Tissue
Multiple Sclerosis
Memory Loss
Treatment
Early Highly Effective Therapies Group
Escalation Therapies Group
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Men and women aged 18 to 60 years.
Established diagnosis of MS, as defined by the 2017 revision of McDonald DiagnosticCriteria (99).
RRMS disease course as defined by the 2013 revisions of the MS clinical coursedefinition (4).
Participants must have evidence of active disease based on: one or more MS relapseswithin the last 18 months prior to screening visit or radiological evidence of MSactivity (≥2 new T2 lesions within the last 12 months from screening [compared to aprevious recent MRI within 18 months of screening] or ≥1 GdE demonstrated on brainor 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 eachtreatment arm.
EDSS at Baseline visit ≤ 6.5
Exclusion
Exclusion Criteria:
Participants with contraindications to all forms of DMT in either of the treatmentarms.
Participants must never have received any of the following medications: natalizumab,alemtuzumab, ocrelizumab, rituximab, ofatumumab, cladribine, siponimod, interferonbeta-1a, interferon beta-1b, pegylated interferon beta-1a, glatiramer acetate,fingolimod, teriflunomide, dimethyl fumarate, daclizumab, mitoxantrone, diroximelfumarate, ozanimod, monomethyl fumarate, ponesimod.
Participants must have not received any of the following medications, for reasonsother than MS, in the last 12 months: cyclophosphamide, azathioprine, mycophenolatemofetil, cyclosporine, methotrexate, leflunomide, laquinimod, atacicept, othermonoclonal antibodies.
Participants with clinically relevant medical or surgical conditions that, in theopinion of the investigator, would put the subject at risk by participating in thestudy
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 movementrelated to tremor.
Unwillingness or inability to comply with the requirements of this protocolincluding the presence of any condition (physical, mental, or social) that, in theopinion of the PI, is likely to affect the participant's ability to comply with thestudy protocol.
Study Design
Connect with a study center
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Cambridge, England CB2 0AH
United KingdomSite Not Available
University Hospitals Coventry and Warwickshire
Coventry, England CV2 2DX
United KingdomSite Not Available
Frimley Park
Frimley, England GU16 7UJ
United KingdomSite Not Available
The Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary
Leeds, England LS1 3EX
United KingdomSite Not Available
University Hospitals Leicester
Leicester, England LE1 5WW
United KingdomSite Not Available
Imperial College Healthcare NHS Trust, Charing Cross Hospital
London, England W6 8RF
United KingdomSite Not Available
University College London Hospitals NHS Foundation Trust, University College Hospital
London, England WC1N 3BG
United KingdomSite Not Available
Salford Royal NHS Foundation Trust, Salford Hospital
Manchester, England M6 8HD
United KingdomSite Not Available
Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital
Oxford, England OX3 9DU
United KingdomSite Not Available
University Hospitals Plymouth NHS Trust, Derriford Hospital
Plymouth, England PL6 8DH
United KingdomSite Not Available
Sheffield Teaching Hospitals
Sheffield, England S5 7AT
United KingdomSite Not Available
University Hospitals of North Midlands
Stoke, England ST4 6QG
United KingdomSite Not Available
Royal Infirmary of Edinburgh
Edinburgh, Scotland EH16 4SA
United KingdomSite Not Available
Cardiff and Vale University Local Health Board, University Hospital of Wales
Cardiff, Wales CF14 4XW
United KingdomSite Not Available
Aneurin Bevan Local Health Board Headquarters, Royal Gwent Hospital
Newport, Wales NP19 0BH
United KingdomSite Not Available
Swansea Bay University Local Health Board, Morriston Hospital
Swansea, Wales SA6 6NL
United KingdomSite Not Available
Nottingham University Hospitals NHS Trust, Queens Medical Centre
Nottingham, NG7 2UH
United KingdomSite Not Available
University of Colorado-Anschutz Medical Campus
Aurora, Colorado 80045
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55902
United StatesSite Not Available
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada 89106
United StatesSite Not Available
University of Buffalo
Buffalo, New York 14202
United StatesSite Not Available
University Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
University of Cincinnati
Cincinnati, Ohio 45267
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Ohio Health
Columbus, Ohio 43214
United StatesSite Not Available
UT-Austin
Austin, Texas 78712
United StatesSite Not Available
Baylor College of Medicine, Houston
Houston, Texas 77030
United StatesSite Not Available
UTHealth-Houston
Houston, Texas 77030
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22903
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23284
United StatesSite Not Available
University of Wisconsin-Madison
Madison, Wisconsin 53705
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.