A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Conditions	Phase	Intervention Type
MS	Phase 3	Drug ocrelizumab Drug Placebo Drug methylprednisolone

View trial NCT01194570 on www.clinicaltrials.gov

Contacts

Please use the information below to contact the trial coordinators.

Eligibility

Ages Eligible for Study: 18 years to 55 years
Genders Eligible for Study: Both

Keywords

Inclusion Criteria

- Adult patients, 18-55 years of age

- Primary Progressive Multiple Sclerosis (according to revised McDonald criteria)

- Expanded Disability Status Scale (EDSS) 3 to 6.5 points

- Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if
EDSS >/= 5.0

- Sexually active male and female patients 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 multiple sclerosis, secondary progressive, or
progressive relapsing multiple sclerosis at screening

- Contraindications for Magnetic Resonance Imaging (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-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

Detailed Description

This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in patients with primary progressive multiple sclerosis. Eligible patients will be randomized 2 : 1 to receive either ocrelizumab (300 mg intravenously, 2 infusions separated by 14 days in each treatment cycle) or placebo. The blinded treatment period will be at least 120 weeks, followed by open label treatment for patients in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Anticipated time on study treatment is up to 5.5 years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194570

Locations

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