Multiple SclerosisNCT02807285
Expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
A study testing Ocrelizumab in people with Multiple Sclerosis, run by Genentech, Inc. at 56 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ocrelizumab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 56 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
United States56 sites
University Of Colorado
Aurora, Colorado, 80045
Steward St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
University of Vermont
Burlington, Vermont, 05401
Mercy Medical Group; MS Centre Nurse
Carmichael, California, 95608
Carolinas Healthcare System
Charlotte, North Carolina, 28208
University of Cincinnati
Cincinnati, Ohio, 45203-0542
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center; Department of Neurology
Columbus, Ohio, 43210
Wayne State Uni /Detroit Medical Center
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
Associated Neurologists of Southern CT PC
Fairfield, Connecticut, 06824
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, 48334
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, 80528
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46805
The Minneapolis Clinic of Neurology
Golden Valley, Minnesota, 55422
University Of Texas Health Science Center Houston
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, 37934
Scripps Clinic
La Jolla, California, 92037
Norton Neurology Services
Louisville, Kentucky, 40207
University of Miami Miller School of Medicine; Clinical Reseach Building
Miami, Florida, 33136
Columbia St. Mary's Hospital System
Milwaukee, Wisconsin, 53211
Advanced Neurosciences Institute
Nashville, Tennessee, 37205
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
MS Center of Southern California
Newport Beach, California, 92663
Consultants in Neurology Ltd
Northbrook, Illinois, 60062
Neurology Associates
Norwich, Connecticut, 06360
Oklahoma Medical Research Foundation; MS Center of Excellence
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198-9450
Neurological Services of Orlando
Orlando, Florida, 32806
Stanford University
Palo Alto, California, 94304
Neuro-Therapeutics Inc.
Pasadena, California, 91105
South Shore Neurologic Associates P.C.
Patchogue, New York, 11772
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Phoenix Neurological Associates Ltd
Phoenix, Arizona, 85006
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Providence Multiple Sclerosis Center
Portland, Oregon, 97225
The Neurology Foundation, Inc.
Providence, Rhode Island, 02905
Raleigh Neurology Associates
Raleigh, North Carolina, 27607-6520
Neurological Associates Inc; Clinical Research
Richmond, Virginia, 23236
Central Texas Neurology Consultants
Round Rock, Texas, 78681
Neurology Center of San Antonio
San Antonio, Texas, 78212
UCSF- Multiple Sclerosis Centre; Department of Neurology
San Francisco, California, 94158
Swedish Neuroscience Institute; Multiple Sclerosis Center
Seattle, Washington, 98122
Washington University
St Louis, Missouri, 63110
Stony Brook University Medical Center
Stony Brook, New York, 11794
Infinity Clinical Research, LLC
Sunrise, Florida, 33351
Multicare Neuroscience Center of Washington
Tacoma, Washington, 98405
University of South Florida
Tampa, Florida, 33612
Holy Name Hospital
Teaneck, New Jersey, 07666
Territory Neurology and Research Institute
Tucson, Arizona, 85704
MS Center of Vero Beach
Vero Beach, Florida, 32960
Neurology and Neuroscience Assoc., Inc.
Westerville, Ohio, 43081
Abington Neurological Associates
Willow Grove, Pennsylvania, 19090
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Ocrelizumab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcrelizumabDrug
Also called RO4964913
Participants will receive 600 mg ocrelizumab as two 300 mg infusions separated by 14 days, every 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807285
- Sponsor's protocol ID
- ML29972
- Status last verified
- Sep 2017
- First submitted
- 16 Jun 2016
- Last updated
- 7 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, MultiCenter, Expanded-Access Program for Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02807285
- Acronym / sponsor ID
- ML29972
- Conditions
- Multiple Sclerosis
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OcrelizumabAlso: RO4964913Participants will receive 600 mg ocrelizumab as two 300 mg infusions separated by 14 days, every 24 weeks. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
Related trials for Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Study of Skin Tumors in Tuberous Sclerosis
Tuberous Sclerosis
Recruiting
The Effects of Synchronous and Asynchronous Pilates Training Based on Telerehabilitation on Core Stabilization, Balance, Cognitive Functions, and Quality of Life in Individuals With Multiple Sclerosis: A Single-Blind Randomized Controlled Trial
Multiple Sclerosis
RecruitingObservational study
Care in Multiple Sclerosis (MS)
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocrelizumab in people with Multiple Sclerosis, run by Genentech, Inc. at 56 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.