Status:
COMPLETED
A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Multiple Sclerosis, Primary Progressive
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
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 parti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 2 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
735 Patients enrolled
Trial Details
Trial ID
NCT01194570
Start Date
March 2 2011
End Date
December 31 2022
Last Update
January 10 2024
Active Locations (184)
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1
Phoenix Neurological Associates Ltd
Phoenix, Arizona, United States, 85006
2
Barrow Neurology Clinic
Phoenix, Arizona, United States, 85013
3
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States, 85259
4
Arizona Neuroscience Research LLC
Phoenix, Arkansas, United States, 85032-2181