Expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02807285
• Other study ID #: ML29972
• Status: No longer available
• Phase: N/A
• First received: June 16, 2016
• Last updated: September 4, 2017

Study information

• Verified date: September 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Sclerosis

Intervention

Drug:
• Ocrelizumab
Participants will receive 600 mg ocrelizumab as two 300 mg infusions separated by 14 days, every 24 weeks.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States,