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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ofatumumab |
20 mg |
|
|
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. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Novartis Pharmaceuticals
Study Contact
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.