A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis
efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV)
infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose
– Diagnosis of relapsing multiple sclerosis (RMS).
– At least two documented clinical attacks within the last 2 years prior to screening,
or one clinical attack in the year prior to screening. No relapse 30 days prior to
screening and at baseline.
– Participants must be neurologically stable for at least 30 days prior to randomization
– Expanded disability status scale (EDSS), at screening and baseline, from 0 to 5.5
– Documented MRI of brain with abnormalities consistent with MS prior to screening.
– Participants requiring symptomatic treatment for MS and/or physiotherapy must be
treated at a stable dose. No initiation of symptomatic treatment for MS or
physiotherapy within 4 weeks of randomization.
– For females of childbearing potential, agreement to remain abstinent or use adequate
– For female participants, without reproductive potential may be enrolled if
post-menopausal, unless receiving a hormonal therapy for her menopause or if
– History of primary progressive MS at screening.
– Any known or suspected active infection at screening or baseline (except nailbed
infections), or any major episode of infection requiring hospitalization or treatment
with IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2
weeks, prior to and during screening.
– History of confirmed or suspected progressive multifocal leukoencephalopathy.
– History of cancer, including hematologic malignancy and solid tumors, within 10 years
– Immunocompromised state.
– Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.
– Inability to complete an MRI or contraindication to gadolinium administration.
– Contraindications to mandatory pre-medications for IRRs.
– Known presence of other neurologic disorders.
– Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the study.
– Significant, uncontrolled disease that may preclude participant from participating in
– History of or currently active primary or secondary, non-drug-related,
– Pregnant or breastfeeding or intending to become pregnant.
– Lack of peripheral venous access.
– History of alcohol or other drug abuse within 12 months prior to screening.
– Treatment with any investigational agent or treatment with any experimental procedure
– Previous use of anti-CD20s if in the last 2 years before screening, or if B-cell count
is not normal, or if treatment was stopped due to safety reasons or lack of efficacy.
– Previous use of mitoxantrone, cladribine, atacicept, and alemtuzumab.
– Previous treatment with any other immunomodulatory or immunosuppressive medication not
already listed above without appropriate washout as described in the applicable local
– If the washout requirements are not described in the applicable local label, then the
wash out period must be five times the half-life of the medication.
– Any previous treatment with bone marrow transplantation and hematopoietic stem cell
– Any previous history of transplantation or anti-rejection therapy.
– Treatment with intravenous (IV) immunoglobulin (Ig) or plasmapheresis within 12 weeks
prior to randomization.
– Systemic corticosteroid therapy within 4 weeks prior to screening.
– Positive screening tests for active, latent, or inadequately treated hepatitis B.
– Sensitivity or intolerance to any ingredient of ocrelizumab.
– Any additional exclusionary criterion as per ocrelizumab local label, if more
stringent than the above.
- North County Neurology Associates, Carlsbad, California, United States, 92011
- University of California Davis Medical Center, Sacramento, California, United States, 95817
- University of California San Francisco, San Francisco, California, United States, 94117
- Stanford University Medical Center; Stanford Neuroscience Health Center, Stanford, California, United States, 94305
- Collaborative Neuroscience Network Inc., Torrance, California, United States, 90502