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

Launched by NOVARTIS PHARMACEUTICALS · Oct 12, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether patients with relapsing-remitting multiple sclerosis (MS) who have not experienced a relapse in the past year would benefit from switching to a medication called ofatumumab, compared to continuing their current treatment. The researchers are particularly interested in patients who have higher levels of a substance called neurofilament light (NfL) in their blood, as this may indicate a greater potential benefit from the switch.

To participate in this study, you need to be between 18 and 45 years old, diagnosed with relapsing-remitting MS, and have been stable on your current treatment for at least six months without any relapses in the last six months. You will be required to attend study visits, get MRI scans, and provide a blood sample. Participants will also use a wearable device to help track their health during the study. If you qualify and choose to join, you'll help researchers learn more about how to improve treatment options for MS patients.

Gender

ALL

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