This study is a prospective, multi-center, randomized, double blinded, placebo-controlled study of OCR treatment-discontinuation in patients with early RMS. All eligible participants will be initiated on OCR using the standard approved administration schedule of two 300 mg infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at Month 6,12, 18, and 24. At Month 24, participants will be randomized (2:1) to one of two Arms with randomized treatment beginning at Month 30: Arm 1: placebo infusions every 6 months; or Arm 2: OCR infusions every 6 months. The treatment period will be for a total of 48 months.
Have at least one clinical episode that satisfies McDonald 2017 criteria for early Multiple sclerosis (MS) with a dissemination in time that can be met clinically, by Magnetic Resonance Imaging (MRI), or based on oligoclonal band (OCB) positivity
Have a length of disease duration, from first symptom, of ≤ 3 years at time of informed consent
A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)
Examples of contraceptive methods include bilateral tubal ligation, male sterilization, established hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices, and copper intrauterine devices
Inability or unwillingness of a participant to give written informed consent or comply with study protocol
History of primary progressive multiple sclerosis (PPMS), progressive relapsing multiple sclerosis (PRMS), or secondary progressive multiple sclerosis (SPMS)
Any metallic material or electronic device in the body, or condition that precludes the participant from undergoing MRI
Ischemic cerebrovascular disorders, including but not limited to transient ischemic attack, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, or cerebral hemorrhage
Parallel
Ocrelizumab
DrugTwo 300 mg intravenous (IV) OCR infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg OCR infusions every 6 months from Month 6 through Month 48.
Placebo for Ocrelizumab
DrugPlacebo infusions every 6 months from Month 30 through Month 48.
Absence of clinical relapse
Durable remission of relapsing disease activity. This is defined as the absence of new relapsing disease activity from Month 24 through Month 48. This includes absence of clinical relapse as well as absence of evidence of MS disease activity by MRI defined by new or enlarging T2 lesions.
The change in Expanded Disability Status Scale (EDSS) score
The Expanded Disability Status Scale (EDSS) score has a minimal value of zero, and maximal value is 10, with higher scores meaning worse outcome.
Proportion of participants with a serious adverse event (SAE)
Proportion of participants who experience at least one Grade 3 or higher adverse event
Using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Adverse events will be graded on a scale from 1 to 5 according to the following standards in the NCI-CTCAE manual: Grade 1 = mild adverse event Grade 2 = moderate adverse event Grade 3 = severe or medically significant Grade 4 = life-threatening consequences; urgent intervention indicated Grade 5 = death
Proportion of participants with infections, Grade 3 or higher
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National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Autoimmunity Centers of Excellence
Collaborator
Rho Federal Systems Division, Inc.
Collaborator
Genentech, Inc.
Collaborator
