Clinical trial NCT02807285: Expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
Official title: An Open Label, MultiCenter, Expanded-Access Program for Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Multiple Sclerosis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no

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.


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
* Known active bacterial, viral, fungal, mycobacterial infection, or other infection
* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the expanded access program (EAP)
* Contraindications for or intolerance to oral or IV corticosteroids, including IV methylprednisolone
* Treatment with therapies approved for relapsing forms of Multiple Sclerosis (MS), including: Beta interferons, glatiramer acetate, fingolimod (Gilenya®), teriflunomide (Aubagio®), dimethyl fumarate (Tecfidera®), IV immunoglobulin, plasmapheresis, or other immunomodulatory therapies within 12 weeks prior to enrollment (Participants should not be excluded from the EAP due to previous treatment with rituximab)
* Participants who have received fingolimod (Gilenya®) or dimethyl fumarate (Tecfidera®) if their lymphocyte count is not within normal values
* Previous treatment with natalizumab (Tysabri®) within 6 months of screening (Participants are not eligible for the EAP if they have been treated with natalizumab (Tysabri) for more than 1 year)
* Any previous treatment with alemtuzumab (Lemtrada®)
* Any previous or current treatment with any experimental procedure for MS

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Neurological Associates Ltd
state: Arizona
city: Tucson
country: United States
facility: Territory Neurology and Research Institute
state: Arizona
city: Carmichael
country: United States
facility: Mercy Medical Group; MS Centre Nurse
state: California
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Newport Beach
country: United States
facility: MS Center of Southern California
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Pasadena
country: United States
facility: Neuro-Therapeutics Inc.
state: California
city: San Francisco
country: United States
facility: UCSF- Multiple Sclerosis Centre; Department of Neurology
state: California
city: Aurora
country: United States
facility: University Of Colorado
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurology of Colorado, LLC
state: Colorado
city: Fairfield
country: United States
facility: Associated Neurologists of Southern CT PC
state: Connecticut
city: Norwich
country: United States
facility: Neurology Associates
state: Connecticut
city: Miami
country: United States
facility: University of Miami Miller School of Medicine; Clinical Reseach Building
state: Florida
city: Orlando
country: United States
facility: Neurological Services of Orlando
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Vero Beach
country: United States
facility: MS Center of Vero Beach
state: Florida
city: Northbrook
country: United States
facility: Consultants in Neurology Ltd
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Neurology Services
state: Kentucky
city: Boston
country: United States
facility: Steward St. Elizabeth's Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State Uni /Detroit Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Farmington Hills
country: United States
facility: Michigan Institute for Neurological Disorders
state: Michigan
city: Golden Valley
country: United States
facility: The Minneapolis Clinic of Neurology
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Hospital
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Patchogue
country: United States
facility: South Shore Neurologic Associates P.C.
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center; Department of Neurology
state: Ohio
city: Westerville
country: United States
facility: Neurology and Neuroscience Assoc., Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation; MS Center of Excellence
state: Oklahoma
city: Portland
country: United States
facility: Providence Multiple Sclerosis Center
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Providence
country: United States
facility: The Neurology Foundation, Inc.
state: Rhode Island
city: Knoxville
country: United States
facility: Sibyl Wray MD Neurology PC
state: Tennessee
city: Nashville
country: United States
facility: Advanced Neurosciences Institute
state: Tennessee
city: Houston
country: United States
facility: University Of Texas Health Science Center Houston
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology Consultants
state: Texas
city: San Antonio
country: United States
facility: Neurology Center of San Antonio
state: Texas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Richmond
country: United States
facility: Neurological Associates Inc; Clinical Research
state: Virginia
city: Seattle
country: United States
facility: Swedish Neuroscience Institute; Multiple Sclerosis Center
state: Washington
city: Tacoma
country: United States
facility: Multicare Neuroscience Center of Washington
state: Washington
city: Milwaukee
country: United States
facility: Columbia St. Mary's Hospital System
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: