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 Genders
- 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. |
|
Recruiting Locations
Birmingham, Alabama 35209
Neptune, New Jersey 07753
732-776-4782
Green Bay, Wisconsin 54311
920-288-8100
Seattle, Washington 98122-4379
206-320-2200
Kirkland, Washington 98034
425-899-5385
Virginia Beach, Virginia 23456
757-507-0642
Webster, Texas 77598
Odessa, Texas 79761
432-368-2138
Lubbock, Texas 79410
806-722-3500
Katy, Texas 77449
Knoxville, Tennessee 37922
865-218-6222
Raleigh, North Carolina 27607
919-719-8826
Charlotte, North Carolina 28210
704-664-8060
Chapel Hill, North Carolina 27599 9500
919-945-4752
Syracuse, New York 13210
Jackson, Mississippi 39216-4505
888-815-2005
Cullman, Alabama 35058
256-739-1210
Orlando, Florida 32806
Phoenix, Arizona 85032
480-210-8723
Torrance, California 90509-2004
949-547-6875
Altamonte Springs, Florida 32714
407-790-4990
Cape Coral, Florida 33904
239-722-9733
Homestead, Florida 33033
305-246-0873
Maitland, Florida 32751
+1 407 647 5996 #7
Pensacola, Florida 32514
850-438-1136
Owosso, Michigan 48867
Tampa, Florida 33612
813-974-6378
Coeur d'Alene, Idaho 83815
208-625-5273
Alexandria, Louisiana 71301
318-769-2862
Lutherville, Maryland 21093
410-828-4629
Worcester, Massachusetts 01608
Detroit, Michigan 48202 2689
313-556-8186
Milwaukee, Wisconsin 53226
414-955-0693
More Details
- NCT ID
- NCT05090371
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
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.