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A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

NCT01194570

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Multiple Sclerosis, Primary Progressive

Interventions: Ocrelizumab, Placebo

Countries: United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (184)

Phoenix, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Phoenix, Arkansas, United States
Berkeley, California, United States
Newport Beach, California, United States
Sacramento, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Miami, Florida, United States
Vero Beach, Florida, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Prairie Village, Kansas, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Farmington Hills, Michigan, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Teaneck, New Jersey, United States
Albuquerque, New Mexico, United States
Mineola, New York, United States
New York, New York, United States
New York, New York, United States
Patchogue, New York, United States
Stony Brook, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
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