A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis

Running, not enrolling · Phase 3

Conditions studied: Progressive Multiple Sclerosis (PMS)

In brief

This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

Key facts

Study ID

NCT03523858

Run by

Hoffmann-La Roche

People needed

927

Starts

2018-05-28

Expected to finish

2026-10-22

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS)
• EDSS (Expanded Disability Status Scale) </ =6.5 at screening
• Have a documented evidence of disability progression independent of relapse at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician's judgment
• Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist
• Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers
• For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 6 months, or longer if the local label is more stringent after the last dose of study drug

You may not qualify if…

• Relapsing-remitting multiple sclerosis (RRMS) at screening
• Inability to complete an MRI
• Gadolinium (Gd) intolerance
• Known presence of other neurological disorders
• Exclusions Related to General Health:
• Pregnancy confirmed by positive serum β human chorionic gonadotropin (hCG) measured at screening
• Lactation
• Any concomitant disease that may require chronic treatment of systemic corticosteroids or immunosuppressants during the course of the study
• History or currently active primary or secondary immunodeficiency
• Lack of peripheral venous access
• Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study.
• Active infections must be treated and resolved prior to the first infusion of ocrelizumab
• Participants in a severely immunocompromised state until the condition resolves
• Participants with known active malignancies or being actively monitored for recurrence of malignancy
• Participants who have or have had confirmed progressive multifocal leukoencephalopathy (PML)
• Exclusions Related to Laboratory Findings:
• Positive screening tests for hepatitis B
• CD4 count <250/μL
• ANC <1.0 × 103/μL
• AST/SGOT or ALT/SGPT ≥3.0 × ULN in combination with either an elevated total bilirubin (>2 X ULN) or clinical jaundice
• Exclusions Related to Medications:
• Hypersensitivity to ocrelizumab or to any of its excipients
• Previous treatment with ocrelizumab
• Previous treatment with B-cell targeted therapies (i.e., atacicept, tabalumab, belimumab, ofatumumab, or obinutuzumab). Note: previous treatment with rituximab is allowed as long as the last dose was administered more than 6 months before the ocrelizumab infusion AND if discontinuation was due to adverse events or immunogenicity AND if Bcell levels are above the lower limit of normal (LLN) prior to screening.
• Any previous treatment with alemtuzumab (Campath/Mabcampath/Lemtrada), total body irradiation, or bone marrow transplantation

Where it is running

• SC3 Research Group, Inc — Pasadena, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of South Florida — Tampa, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dragonfly Research, LLC — Wellesley, Massachusetts, United States
• Wayne State University School of Medicine — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• The MS Center of Northeastern New York — Latham, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Neurology Clinic PC — Cordova, Tennessee, United States
• Central Texas Neurology Consultants — Round Rock, Texas, United States
• Lone Star Neurology of San Antonio — San Antonio, Texas, United States
• Swedish Multiple Sclerosis Center — Seattle, Washington, United States
• University Clinical Center of the Republic of Srpska — Banja Luka, Bosnia and Herzegovina
• University Hospital Mostar — Mostar, Bosnia and Herzegovina
• Clinical Center University of Sarajevo — Sarajevo, Bosnia and Herzegovina
• University Clinical Center Tuzla — Tuzla, Bosnia and Herzegovina
• Instituto de Neurologia de Curitiba — Curitiba, Paraná, Brazil
• Hospital Sao Lucas - PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
• Hospital das Clínicas Faculdades Médicas de Ribeirão Preto — Ribeirão Preto, São Paulo, Brazil
• Hospital das Clinicas - FMUSP_X — São Paulo, São Paulo, Brazil
• Fraser Health Authority - Fraser Health Multiple Sclerosis — Burnaby, British Columbia, Canada
• University of British Columbia Hospital — Vancouver, British Columbia, Canada
• MS Center of California — Laguna Hills, California, United States

Full record on ClinicalTrials.gov

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