A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis, Primary Progressive	Drug: ocrelizumab Drug: Placebo Drug: methylprednisolone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Efficacy: Time to onset of sustained disability progression, defined as an increase in Expanded Disability Status Scale (EDSS) score that is sustained for at least 12 weeks [ Time Frame: up to 5.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to sustained disability progression, defined as an increase in EDSS score that is sustained for at least 24 weeks [ Time Frame: up to 5.5 years ] [ Designated as safety issue: No ]
Change in timed 25-foot walk [ Time Frame: from baseline to Week 120 ] [ Designated as safety issue: No ]
Change in total volume of T2 lesions on magnetic resonance imaging (MRI) scans of the brain [ Time Frame: from baseline to Week 180 ] [ Designated as safety issue: No ]
Safety and tolerability: Incidence of adverse events [ Time Frame: up to 5.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	630
Study Start Date:	March 2011
Estimated Study Completion Date:	November 2017
Estimated Primary Completion Date:	November 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: ocrelizumab 2 intravenous infusions of 300 mg separated by 14 days in each treatment cycle Drug: methylprednisolone 100 mg iv 30 minutes prior to ocrelizumab or placebo infusion
Placebo Comparator: B	Drug: Placebo Ocrelizumab placebo, 2 infusions separated by 14 days in each treatment cycle Drug: methylprednisolone 100 mg iv 30 minutes prior to ocrelizumab or placebo infusion

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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

Contacts

Contact: Please reference Study ID Number: WA25046 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 218 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01194570 History of Changes
Other Study ID Numbers:	WA25046, 2010-020338-25
Study First Received:	August 28, 2010
Last Updated:	May 13, 2013
Health Authority:	Peru: Instituto Nacional de Salud (INS)

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Chronic Progressive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone

Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on May 22, 2013