Type of MS: RRMS|SPMS
Treatment mode of action: To affect immune functoin
Number of Subjects: 1
Medication: ofatumumab
Location: New York
Institutions: Five Towns Neuroscience Research
923 Broadway Suite B
Woodmere, NY 11598
Contact Information
Fola Akinbolaji
(516)-239-4433
f.akinbolaji@threewire.com
Funding:
Novartis
Description
A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and
patient- reported outcomes in people with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy.
FDA Approved medication (Brand name: KESIMPTA)
Open Label
96 weeks long
Once monthly dose
Self-administered
Key inclusion criteria:
1. Diagnosis of MS
2. Relapsing MS (RRMS or SPMS) course
3. Subject transitioning from either fingolimod or dimethyl fumarate, following min 6 months treatment with either drug
4. MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs), where all fumarates are considered as one DMT
5. Breakthrough disease activity while the participant was adequately using fumarates or fingolimod prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)