A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

Roche

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis, Primary Progressive

Treatments: Drug: Ocrelizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01194570

2010-020338-25 (EudraCT Number)

WA25046

Details and patient eligibility

About

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.

Enrollment: 735 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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735 participants in 2 patient groups, including a placebo group

Placebo

Experimental group

Description:

Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.

Treatment:

Other: Placebo

Drug: Ocrelizumab

Ocrelizumab 600 mg

Placebo Comparator group

Description:

Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.

Treatment:

Drug: Ocrelizumab