An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis.
Dr Emmanuelle Waubant is conducting a multicenter, research study evaluating the effectiveness and safety of ocrelizumab treatment in patients with progressive multiple sclerosis (PMS). The study includes patients diagnosed with primary progressive multiple sclerosis, and secondary progressive multiple sclerosis. The primary aim of the study is to evaluate the effectiveness of ocrelizumab treatment in patients with PMS disease course.
The study will consist of Screening period (up to 4 weeks), treatment period of 192 weeks, and follow-up period of at least 48 weeks. Ocrelizumab is FDA approved for the treatment of primary progressive MS study. All study participants will receive the study drug free of cost for 4 years. This study visits will be conducted at our research center located at UCSF Mission Bay campus.
The study procedures include physical exam, completing questionnaires, testing of blood samples, and magnetic resonance imaging (MRI). Study medication will be given intravenously (administered into the vein). During the first 48 weeks of the study, patient will be allocated into 2 groups, where group 1 will receive a preconfigured and locked-in Samsung Galaxy smartphone and will use the FLOODLIGHT RPM Test Battery installed on the smartphone, and the group 2 will not receive a smartphone and will not use the FLOODLIGHT RPM Test Battery. The software set up in the smartphone is called as FLOODLIGHT RPM Test Battery, which will prompt you to perform the tests during study visits and at home.
For more information: https://clinicaltrials.ucsf.edu/trial/NCT03523858