Clareo Health | A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of RMS/PPMS in accordance with the revised 2017 McDonald Criteria
EDSS score from 0-5.5 (RMS) or 3.0-6.5 (PPMS), inclusive, at screening and baseline
Documented MRI of brain with abnormalities consistent with MS before screening
You may not be if
Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) (only for RMS cohort)
History of relapsing remitting multiple sclerosis (RRMS) or SPMS at screening (only for PPMS cohort)
Disease duration of more than 10 years in participants with an EDSS ≤ 2.0 at screening (only for RMS cohort)
History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
Inability to complete an MRI scan or contraindication to Gd administration
Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines)
Known presence of other neurologic disorders if they could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Known history of human immunodeficiency virus (HIV) infection
Lack of peripheral venous access
Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab), unless the last infusion was at least 6 months prior to screening
Positive screening tests for hepatitis B virus (HBV) and/or hepatitis C virus (HCV)
