A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis, Primary Progressive

In brief

This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo.

Key facts

Study ID

NCT01194570

Run by

Hoffmann-La Roche

People needed

735

Starts

2011-03-02

Expected to finish

2022-12-31

Last updated by the study team

2024-01-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of primary progressive multiple sclerosis (according to revised McDonald criteria)
• EDSS at screening from 3 to 6.5 points
• Disease duration from onset of MS symptoms less than (<) 15 years if EDSS greater than (>) 5.0; <10 years if EDSS greater than or equal to (>/=) 5.0
• Sexually active male and female participants of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose

You may not qualify if…

• History of relapsing remitting MS, secondary progressive, or progressive relapsing MS at screening
• Inability to complete an MRI (contraindications for MRI)
• Known presence of other neurologic disorders
• Known active infection or history of or presence of recurrent or chronic infection
• History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
• Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
• Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-cluster of differentiation 4 (CD4), cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study

Where it is running

• Barrow Neurology Clinic — Phoenix, Arizona, United States
• Mayo Clinic- Scottsdale — Scottsdale, Arizona, United States
• Arizona Neuroscience Research LLC — Phoenix, Arkansas, United States
• Sutter East Bay Medical Foundation — Berkeley, California, United States
• MS Center of Southern California — Newport Beach, California, United States
• Univ of CA Davis Med Ctr; Neurology — Sacramento, California, United States
• Univ of CA San Francisco; Department of Neurology — San Francisco, California, United States
• University of Colorado; Anschutz Medical Campus Department of Neurology — Aurora, Colorado, United States
• University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center — Miami, Florida, United States
• Vero Beach Neurology and Research Institute — Vero Beach, Florida, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• MidAmerica Neuroscience Institute — Prairie Village, Kansas, United States
• Wayne State University; Department of Neurology — Detroit, Michigan, United States
• Henry Ford Health System; Neurology & Neurosurgery — Detroit, Michigan, United States
• Michigan Institute for Neurological Disorders — Farmington Hills, Michigan, United States
• University of Minnesota; Clin. Neuro Research Unit — Minneapolis, Minnesota, United States
• Washington University School of Medicine; Department of Neurology — St Louis, Missouri, United States
• Holy Name Hospital — Teaneck, New Jersey, United States
• University of New Mexico; MS Specialty Clinic — Albuquerque, New Mexico, United States
• Winthrop University Hospital — Mineola, New York, United States
• Weill Medical College of Cornell University; Judith Jaffe MS Ctr — New York, New York, United States
• Mount Sinai School of Medicine; Neurology — New York, New York, United States
• Comprehensive MS Care Center at South Shore Neurologic Assoc. — Patchogue, New York, United States
• Phoenix Neurological Associates Ltd — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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