An Open Label, MultiCenter, Expanded-Access Program for Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Genentech, Inc.56 sites in 1 countryJune 21, 2016

ConditionsMultiple Sclerosis

DrugsOcrelizumab

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: Genentech, Inc.
Locations: 56
Status: No Longer Available
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this expanded access program is to provide ocrelizumab as treatment for eligible participants with primary progressive multiple sclerosis (PPMS) before it is commercially available in the United States (U.S.) for the indication of PPMS.

Registry

clinicaltrials.gov

Start Date

June 21, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Expanded Access

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 to 55 years (inclusive)
•Diagnosis of PPMS in accordance with the revised 2010 McDonald criteria and the presence or documented history of cerebrospinal fluid oligoclonal bands by isoelectric focusing or elevated immunoglobulin G (IgG) index
•Expanded Disability Status Score (EDSS) of 2.0 to 6.5 points at screening
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (\<)1 percent (%) per year during the treatment period and for at least 24 weeks after the last dose of study treatment or until their B-cells have repleted, whichever is longer

Exclusion Criteria

•History of relapsing-remitting multiple sclerosis (RRMS), progressive relapsing multiple sclerosis (PRMS) or secondary progressive multiple sclerosis (SPMS) at screening
•History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
•History or known presence of recurrent or chronic infection
•History of recurrent aspiration pneumonia requiring antibiotic therapy
•History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved with documented clean margins on pathology)
•History of or currently active primary or secondary immunodeficiency
•History of coagulation disorders because ocrelizumab is administered via infusion
•Known presence or history of other neurologic disorders
•Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including chronic obstructive pulmonary disease), renal, hepatic, endocrine, gastrointestinal, or any other significant disease
•Congestive heart failure