Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
NCT ID: NCT05084638
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
180 participants
INTERVENTIONAL
2022-01-25
2026-02-16
Brief Summary
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Detailed Description
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After giving consent, participants will have a 28-day screening/qualification period. If they qualify to continue, they will start study measures including assessments of clinical and magnetic resonance imaging (MRI) metrics and use of a digital monitoring watch. Additionally, samples will be collected for laboratory and biomarker analysis. RRMS participants will begin treatment with ofatumumab for the next 18 months. Healthy participants will undergo similar assessments; however they will not receive any treatment during the course of the study. Over the 18 months, participants will have regular clinical visits with assessments and sample collection. After 18 months in the trial, participants in both groups will have the option to enter into a 12-month extension (up to 30 months total in study) to collect further information on long-term clinical and MRI outcomes.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ofatumumab
Ofatumumab will be provided in an autoinjector for subcutaneous administration. Dosing regimen for this study is an initial dose of 20mg at Baseline/Week 0, followed by Week 1, 2 and every month thereafter, beginning at Week 4 (Month 1) until Month 18. There will be an optional extension of dosing through month 30.
Ofatumumab
20mg subcutaneous injection
Healthy Control
Healthy Control arm will be age- and sex-matched subjects (to the ofatumumab treated arm) and will not receive a study treatment.
No interventions assigned to this group
Interventions
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Ofatumumab
20mg subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Signed informed consent must be obtained prior to participation in the study
2. Age 18-35 years
Patients in the healthy control arm eligible for inclusion must fulfill the following criteria:
3. Able to obtain MRI (HC with abnormal MRI at Screening will be excluded) and use wearable device
4. Able to provide blood sample (no CSF will be collected in HC)
Patients in the ofatumumab-treated arm eligible for inclusion must fulfill the following criteria:
5. Diagnosis of RRMS per McDonald Criteria (2010/2017)
6. Within 6 months of diagnosis of clinically definite MS (CDMS)
7. EDSS 0-3.0 (Inclusive)
8. Treatment-naïve to MS DMT
9. Able to obtain MRI and attend study visits at sites
10. Able to use wearable device
11. Able to provide blood sample (and CSF for sub-group n=15)
Exclusion Criteria
1. Confounding medical condition as determined by the investigator
2. Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
3. Patients with neuromyelitis optica, Radiologic/ Clinically Isolated Syndrome, Secondary Progressive or Primary Progressive MS diagnosis
4. Use of experimental or investigational drugs for MS
5. Previous use of Disease Modifying Therapy (DMT) or chemotherapeutic medications for MS
6. Relapse between screening and Baseline visits
7. Known sensitivity to gadolinium; patients with chronic, severe kidney disease
8. Known history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
9. CNS anomalies that are better accounted for by another disease process or MRI anomalies causing clinically apparent impairments
10. Known active malignancies
11. Pregnant or nursing (lactating) women
12. Females of childbearing potential (all women physiologically capable of becoming pregnant) should use effective contraception while receiving ofatumumab and for 6 months after the last treatment of ofatumumab
13. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS or with immunodeficiency syndrome
14. Patients with active infections including systemic bacterial, viral (including SARS-CoV-2/COVID-19) or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening
15. Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
16. Patients with IgG or IgM levels below LLN at Screening
17. Patients that have received any live or live-attenuated vaccines within 4 weeks prior to first dose of study drug administration
18. Patients at risk of developing or having reactivation of hepatitis
18 Years
35 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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MD First Research
Chandler, Arizona, United States
Barrow Neurological Clinics at St Josephs Hospital and MC
Phoenix, Arizona, United States
Arizona Neuroscience Research LLC
Phoenix, Arizona, United States
Keck School of Medicine
Los Angeles, California, United States
Lundquist Inst BioMed at Harbor
Torrance, California, United States
Regina Berkovich MD PhD Inc
West Hollywood, California, United States
UC Health Neuroscience Ctr
Aurora, Colorado, United States
MedStar Health
Washington D.C., District of Columbia, United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, United States
First Choice Neurology
Boca Raton, Florida, United States
Univ of Florida College of Medicine
Gainesville, Florida, United States
Neurology Associates PA
Maitland, Florida, United States
Orlando Health Clinical Trials
Orlando, Florida, United States
Emerald Coast Neurology
Pensacola, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
University Of South Florida
Tampa, Florida, United States
Shepherd Center
Atlanta, Georgia, United States
Ochsner Cancer Institute
New Orleans, Louisiana, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Renown Institute for Neurosciences
Reno, Nevada, United States
Neuroscience Institute at Hackensack
Hackensack, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Velocity Clinical Research
Raleigh, North Carolina, United States
Neurology Diagnostics Inc
Dayton, Ohio, United States
Multiple Sclerosis Center of Excellence of OMRF
Oklahoma City, Oklahoma, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, United States
Univ of Texas Southwest Med Center
Dallas, Texas, United States
UT Health Science Center
Houston, Texas, United States
Lonestar Neurology of San Antonio
San Antonio, Texas, United States
Evergreen Health Multiple Sclerosis Center
Kirkland, Washington, United States
MultiCare Neuroscience Center of Washington
Tacoma, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Caribbean Center for Clinical Research, Inc
Guaynabo, , Puerto Rico
Countries
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Other Identifiers
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COMB157GUS10
Identifier Type: -
Identifier Source: org_study_id
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