A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation

Purpose

This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.

Condition

  • Relapsing-Remitting Multiple Sclerosis

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Signed informed consent must be obtained prior to participation in the study. - Age 18-45 years - Diagnosis of RRMS per McDonald Criteria (2017) - EDSS 0-5.5 (Inclusive) - Able to obtain MRI and attend study visits at sites - Willing to use wearable device as specified in the protocol - Able to provide blood sample - On a current DMT with approved label use for treatment of RRMS at least 6 months prior to Screening - No relapse reported within 6 months prior to Screening - Patients may enroll in the trial if they have subclinical disease activity as measured by MRI prior to enrollment. An absence of MRI activity is not exclusionary.

Exclusion Criteria

  • Primary progressive or secondary progressive phenotype - Diseases other than multiple sclerosis responsible for the clinical or MRI presentation - Use of experimental or investigational drugs for MS within 2 years from Screening - Known sensitivity to gadolinium - Central Nervous System (CNS) anomalies that are better accounted for by another disease process - Known active malignancies - Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS - Active infections including systemic bacterial, viral (including COVID-19) or fungal infections, known to have AIDS or tested positive for HIV antibodies - Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML - IgG or IgM levels below lower limit of normal (LLN) at Screening

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A randomized, open label, multi-center, active-comparator study
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ofatumumab 		20 mg
  • Drug: Ofatumumab
    3 loading doses followed by administration every 4 weeks as per label
Active Comparator
DMT continued therapy 		Participants randomized to the continued therapy arm will continue to take their disease modifying treatment (DMT) as prescribed commercially by their physician.
  • Drug: Disease modifying treatment (DMT)
    Other DMT with approved label use for treatment which participants were on at least 6 months prior to Screening

Recruiting Locations

Alabama Neurology Associates PC
Birmingham 4049979, Alabama 4829764 35209

North Central Neurology Associates PC
Cullman 4057835, Alabama 4829764 35058
Contact:
+1 256 739 1210

Radiant Research Chandler
Chandler 5289282, Arizona 5551752 85224

Arizona Neuroscience Research LLC
Phoenix 5308655, Arizona 5551752 85032
Contact:
+1 480 210 8723

University of California at Los Angeles
Torrance 5403022, California 5332921 90509-2004
Contact:
+1 949 547 6875

Neurology of Central FL Res Ctr
Altamonte Springs 4145941, Florida 4155751 32714
Contact:
+1 407 790 4990

S And D Clinical Research
Cape Coral 4149962, Florida 4155751 33904
Contact:
+1 239 722 9733

Homestead Assoc In Research Inc
Homestead 4159050, Florida 4155751 33033
Contact:
+1 305 246 0873

Neurology Associates PA
Maitland 4163220, Florida 4155751 32751
Contact:
+1 407 647 5996 #7

Orlando Health Clinical Trials
Orlando 4167147, Florida 4155751 32806
Contact:
Tiffany Gilliard
+1 407 352 5434
Tiffany.gilliard@orlandohealth.com

Emerald Coast Neurology
Pensacola 4168228, Florida 4155751 32514
Contact:
+1 850 438 1136

University Of South Florida
Tampa 4174757, Florida 4155751 33612
Contact:
+1 813 974 6378

Kootenai Health
Coeur d'Alene 5589173, Idaho 5596512 83815
Contact:
+1 208 625 5273

Neuro Medial Clinic of Central Louisiana
Alexandria 4314550, Louisiana 4331987 71301
Contact:
+1 318 769 2862

International Neurorehab Institute
Lutherville 4361379, Maryland 4361885 21093
Contact:
+1 410 828 4629

Reliant Medical Group
Worchester, Massachusetts 6254926 01608
Contact:
Candace Leblanc
+1 508 368 3168
candace.leblanc@reliantmedicalgroup.org

Henry Ford Hospital
Detroit 4990729, Michigan 5001836 48202 2689
Contact:
+1 313 556 8186

Memorial Healthcare
Owosso 5004792, Michigan 5001836 48867

University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39216-4505
Contact:
+1 888 815 2005

St Barnabas Medical Center
Livingston 5100572, New Jersey 5101760 07039

Jersey Shore University Medical Ctr
Neptune City 5101687, New Jersey 5101760 07753
Contact:
+1 732 776 4782

SUNY Upstate Medical Center
Syracuse 5140405, New York 5128638 13210

University Of NC At Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599 9500
Contact:
+1 919 945 4752

Piedmont HealthCare
Charlotte 4460243, North Carolina 4482348 28210
Contact:
+1 704 664 8060

Velocity Clinical Research
Raleigh 4487042, North Carolina 4482348 27607
Contact:
+1 919 719 8826

Palmetto Clinical Research
Summerville 4597919, South Carolina 4597040 29485
Contact:
+1 843 851 7098

Sibyl Wray MD Neurology PC
Knoxville 4634946, Tennessee 4662168 37922
Contact:
+1 865 218 6222

Clinical Trial Network
Houston 4699066, Texas 4736286 77074
Contact:
Santiago Rios
srios@ctntexas.com

Neuro Mind Clinical Trials Ltd Co
Katy 4702732, Texas 4736286 77449

Covenant Medical Group
Lubbock 5525577, Texas 4736286 79410
Contact:
+1 806 722 3500

West Texas Cancer Center
Odessa 5527554, Texas 4736286 79761
Contact:
+1 432 368 2138

Tranquil Clinical Research
Webster 4740423, Texas 4736286 77598
Contact:
Amber Christian
+1 713 906 6316
amberc@tranquilityresearch.com

Sentara Neuroscience Institute
Virginia Beach 4791259, Virginia 6254928 23456
Contact:
+1 757 507 0642

Evergreen Health Multiple Sclerosis Center
Kirkland 5799841, Washington 5815135 98034
Contact:
+1 425 899 5385

Swedish Medical Center
Seattle 5809844, Washington 5815135 98122-4379
Contact:
+1 206 320 2200

Aurora BayCare Medical Center
Green Bay 5254962, Wisconsin 5279468 54311
Contact:
+1 920 288 8100

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
+1 414 955 0693

More Details

NCT ID
NCT05090371
Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Detailed Description

This is a multicenter, prospective study of up to 150 relapsing-remitting MS participants/ The study is looking to see if patients who have not had a relapse in the past year would benefit from switching to ofatumumab. After giving consent, participants will have a 1 week screening/qualification period. If they qualify to continue, they will start a a six month run-in period during which lab samples will be collected. Patients that are relapse-free during the run-in period will continue into next period of the study in which they will be randomized to either ofatumumab or continued therapy for the next 15 months. Every 3 out of 5 randomized participants will be selected to wear a digital study watch to collect physical activity, sleep, and vitals during this 15 month period. The study watch will be worn 24 hours a day, 7 days a week but can be removed during showers/bathing. At the end of the 15 month period, a study completion visit will be held. The total study duration is 21 months plus 1 week for screening/qualification.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center