Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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 participants will be randomized 2 : 1 to receive either ocrelizumab or
placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label
Extension (OLE) treatment for participants in both groups who in the opinion of the
investigator could benefit from further or newly initiated ocrelizumab treatment. Unless
terminated early, all participants may continue their treatment with open-label ocrelizumab
until 31 December 2020.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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