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

• Status: Not yet recruiting
• Trial end date: 2024-10-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ofatumumab

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