Active, Not RecruitingPhase 4DMT
A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation
Sponsored by Novartis Pharmaceuticals
NCT ID
NCT05090371
Target Enrollment
136 participants
Start Date
2022-03-02
Est. Completion
2027-04-13
About This Study
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.
Conditions Studied
Interventions
- •Ofatumumab
- •Disease modifying treatment (DMT)
Eligibility
Age:18 Years - 50 Years
Healthy Volunteers:No
View full eligibility criteria
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 Locations (43)
Alabama Neurology Associates PC
Birmingham, Alabama, United States
North Central Neurology Associates PC
Cullman, Alabama, United States
Radiant Research Chandler
Chandler, Arizona, United States
Arizona Neuroscience Research LLC
Phoenix, Arizona, United States
University of California at Los Angeles
Torrance, California, United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, United States
S And D Clinical Research
Cape Coral, Florida, United States
Homestead Assoc In Research Inc
Homestead, Florida, United States
Neurology Associates PA
Maitland, Florida, United States
Orlando Health Clinical Trials
Orlando, Florida, United States
+33 more locations