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

September 4, 2017 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Phoenix Neurological Associates Ltd
      • Tucson, Arizona, United States, 85704
        • Territory Neurology and Research Institute
    • California
      • Carmichael, California, United States, 95608
        • Mercy Medical Group; MS Centre Nurse
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • Newport Beach, California, United States, 92663
        • MS Center of Southern California
      • Palo Alto, California, United States, 94304
        • Stanford University
      • Pasadena, California, United States, 91105
        • Neuro-Therapeutics Inc.
      • San Francisco, California, United States, 94158
        • UCSF- Multiple Sclerosis Centre; Department of Neurology
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Fort Collins, Colorado, United States, 80528
        • Advanced Neurology of Colorado, LLC
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Associated Neurologists of Southern CT PC
      • Norwich, Connecticut, United States, 06360
        • Neurology Associates
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine; Clinical Reseach Building
      • Orlando, Florida, United States, 32806
        • Neurological Services of Orlando
      • Sunrise, Florida, United States, 33351
        • Infinity Clinical Research, LLC
      • Tampa, Florida, United States, 33612
        • University of South Florida
      • Vero Beach, Florida, United States, 32960
        • MS Center of Vero Beach
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Consultants in Neurology Ltd
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Fort Wayne Neurological Center
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Neurology Services
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Steward St. Elizabeth's Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48201
        • Wayne State Uni /Detroit Medical Center
      • Farmington Hills, Michigan, United States, 48334
        • Michigan Institute for Neurological Disorders
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • The Minneapolis Clinic of Neurology
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68198-9450
        • University of Nebraska Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers New Jersey Medical School
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Hospital
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • Patchogue, New York, United States, 11772
        • South Shore Neurologic Associates P.C.
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28208
        • Carolinas Healthcare System
      • Raleigh, North Carolina, United States, 27607-6520
        • Raleigh Neurology Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45203-0542
        • University Of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center; Department of Neurology
      • Westerville, Ohio, United States, 43081
        • Neurology and Neuroscience Assoc., Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Medical Research Foundation; MS Center of Excellence
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Multiple Sclerosis Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
      • Willow Grove, Pennsylvania, United States, 19090
        • Abington Neurological Associates
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • The Neurology Foundation, Inc.
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Sibyl Wray MD Neurology PC
      • Nashville, Tennessee, United States, 37205
        • Advanced Neurosciences Institute
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center Houston
      • Round Rock, Texas, United States, 78681
        • Central Texas Neurology Consultants
      • San Antonio, Texas, United States, 78212
        • Neurology Center of San Antonio
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont
    • Virginia
      • Richmond, Virginia, United States, 23236
        • Neurological Associates Inc; Clinical Research
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Neuroscience Institute; Multiple Sclerosis Center
      • Tacoma, Washington, United States, 98405
        • MultiCare Neuroscience Center of Washington
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • Columbia St. Mary's Hospital System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML29972

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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