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Multiple Sclerosis, Relapsing-RemittingPhase 3NCT02637856

A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)

A Phase 3 study testing Ocrelizumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Genentech, Inc. at 82 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
Ocrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
608 participants
Where
82 sitesin 2 countries
Study dates
11 Feb 2016to 3 May 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Diagnosis of multiple sclerosis (specifically RRMS), in accordance with the revised 2010 McDonald criteria
  • Disease duration from first symptom of less than or equal to (</=) 12 years
  • Treated with an adequate course of treatment with no more than three prior DMT regimens of greater than or equal to (>/=) 6 months, and the discontinuation of the most recent adequately used DMT was due to suboptimal response
  • Suboptimal response while the participant was on his/her last adequately used DMT for >/=6 months (defined by having one of the following qualifying events despite being on a stable dose of the same DMT for at least 6 months: one or more clinically reported relapses, one or more T1 Gd-enhanced lesions, or two or more new or enlarging T2 lesions on MRI); these qualifying events must have occurred while on the last adequately used DMT. In participants receiving stable doses of the same approved DMT for more than a year, the event must have occurred within the last 12 months of treatment with this DMT from the date of screening

Who cannot join

  • History of primary progressive multiple sclerosis (PPMS), progressive relapsing multiple sclerosis (PRMS), or secondary progressive multiple sclerosis (SPMS)
  • Contraindications for MRI
  • Known presence of other neurological disorders that may mimic multiple sclerosis
  • Pregnancy or lactation, or intention to become pregnant during the study
  • Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History of or currently active primary or secondary immunodeficiency
Show all 18Show fewer
  • Lack of peripheral venous access
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Active infection, or history of or known presence of recurrent or chronic infection such as human immunodeficiency virus (HIV), syphilis, or tuberculosis
  • History of progressive multifocal leukoencephalopathy
  • Contraindications to or intolerance of oral or IV corticosteroids
  • Previous treatment with fingolimod (Gilenya®) or dimethyl fumarate (Tecfidera®) in participants whose lymphocyte count is below the lower limit of normal (LLN)
  • Treatment with alemtuzumab (Lemtrada®)
  • Previous treatment with systemic cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, or methotrexate
  • Previous treatment with natalizumab within 12 months prior to screening unless failure was due to confirmed, persistent anti-drug antibodies (ADAs). Participants previously treated with natalizumab will be eligible for this study only if duration of treatment with natalizumab was less than (<) 1 year and natalizumab was not used in the 12 months prior to screening. Anti-John Cunningham virus (JCV) antibody status (positive or negative) and titer (both assessed within the year of screening) must be documented prior to enrollment
  • Treatment with dalfampridine (Ampyra®) unless on stable dose for >/=30 days prior to screening
  • Treatment with a B-cell targeted therapies (e.g., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
  • Treatment with a drug that is experimental (Exception: treatment with an experimental drug that was subsequently approved in the participant's country is allowed)

Trial locations and contacts

82 sites in 2 countries.

82 sites in 2 countries

United States67 sites

  • Ms Center Of Atlanta

    Atlanta, Georgia, 30327

  • American Health Network Institute, LLC

    Avon, Indiana, 46123

  • University of Maryland Medical Center; Department of Neurology

    Baltimore, Maryland, 21201

  • John Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.

    Basalt, Colorado, 81621

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Med Ctr; Neurology/MS Center

    Boston, Massachusetts, 02215

  • Jacobs Neurological Institute

    Buffalo, New York, 14203

  • The Research Center of Southern California, LLC

    Carlsbad, California, 92011

  • Mercy Medical Group; MS Centre Nurse

    Carmichael, California, 95608

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112

  • University of Chicago Hospital

    Chicago, Illinois, 60637

  • UC Health Clinical Trials Office

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40

    Cleveland, Ohio, 44195

  • The Ohio State University Wexner Medical Center; Department of Neurology

    Columbus, Ohio, 43210

  • Neurology Clinic PC

    Cordova, Tennessee, 38018

  • North Central Neurology Associates

    Cullman, Alabama, 35058

  • Neurology Specialists, Inc

    Dayton, Ohio, 45417

  • Wayne State University; Department of Neurology

    Detroit, Michigan, 48201

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • Associated Neurologists of Southern CT PC

    Fairfield, Connecticut, 06824

  • Advanced Neurology of Colorado, LLC

    Fort Collins, Colorado, 80528

  • Fullerton Neurology and Headache Center

    Fullerton, California, 92835

  • Minneapolis Clinic of Neurology

    Golden Valley, Minnesota, 55422

  • Uni of Texas Health Science Center At Houston

    Houston, Texas, 77030

  • Josephson Wallack Munshower Neurology PC

    Indianapolis, Indiana, 46256

  • University of Kansas Medical Center; Division of Nuclear Medicine

    Kansas City, Kansas, 66160

  • Hope Neurology

    Knoxville, Tennessee, 37922

  • Scripps Health

    La Jolla, California, 92037

  • Cleveland Clinic Lou Ruvo; Center for Brain Research

    Las Vegas, Nevada, 89106

  • The MS Center of Northeastern New York

    Latham, New York, 12110

  • Lahey Clinic Med Ctr

    Lexington, Kentucky, 02421

  • Associates in Neurology PSC

    Lexington, Kentucky, 40513

  • Community Medical Associates Inc.; d.b.a. Norton Neurology Services MS Services

    Louisville, Kentucky, 40207

  • Bhupesh Dihenia M.D. P.A.

    Lubbock, Texas, 79410

  • Neurology Associates PA

    Maitland, Florida, 32751

  • University of Miami Miller School of Medicine; Clinical Reseach Building

    Miami, Florida, 33136

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10032

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Consultants in Neurology Ltd

    Northbrook, Illinois, 60062

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • South Shore Neurologic Associates P.C.

    Patchogue, New York, 11772

  • Phoenix Neurological Associates Ltd

    Phoenix, Arizona, 85006

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Allegheny Neurological Associates

    Pittsburgh, Pennsylvania, 15212

  • Island Neurological Associates, P.C.

    Plainview, New York, 11803

  • Neurostudies Inc

    Port Charlotte, Florida, 33952

  • Providence Multiple Sclerosis Center

    Portland, Oregon, 97225

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607-6520

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • Rocky Mountain MS Clinic

    Salt Lake City, Utah, 84103

  • Neurology Center of San Antonio

    San Antonio, Texas, 78212

  • UCSF- Multiple Sclerosis Centre; Department of Neurology

    San Francisco, California, CA94158

  • Swedish Neuroscience Institute

    Seattle, Washington, 98122

  • Washington University School of Medicine; Department of Neurology

    St Louis, Missouri, 63110

  • KI Health Partners, LLC; New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • Infinity Clinical Research, LLC

    Sunrise, Florida, 33351

  • MultiCare Health System Institute for Research and Innovation

    Tacoma, Washington, 98405

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • University of South Florida - Bradenton

    Tampa, Florida, 33612

  • Holy Name Hospital; Institute For Clinical Research

    Teaneck, New Jersey, 07666

  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Territory Neurology and Research Institute

    Tucson, Arizona, 85704

  • Dragonfly Research, LLC

    Wellesley, Massachusetts, 02481

  • Neurology and Neuroscience Assoc., Inc.

    Westerville, Ohio, 43081

  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Canada15 sites

  • Fraser Health Multiple Sclerosis Clinic; Burnaby Hospital Pharmacy

    Burnaby, British Columbia, V5G 2X6

  • Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience

    Calgary, Alberta, T2N 2T9

  • University of Alberta; Divison of Pulmonary Medicine, Dept. of Medicine,

    Edmonton, Alberta, T6C 2G3

  • Clinique NeuroOutaouais

    Gatineau, Quebec, J8Y 1W2

  • Recherche Sepmus, Inc.

    Greenfield Park, Quebec, J4V 2J2

  • Dalhousie Multiple Sclerosis Research Unit

    Halifax, Nova Scotia, B3H 4K4

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • Hopital Hotel Dieu de Levis

    Lévis, Quebec, G6V 3Z1

  • Chum Campus Notre Dame

    Montreal, Quebec, H2X 0A9

  • McGill University; Montreal Neurological Institute; Neurological and Psychiatric

    Montreal, Quebec, H3A 2B4

  • The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis

    Ottawa, Ontario, K1H 8L6

  • CHU De Quebec Universite Laval

    Québec, G1J 1Z4

  • Horizon Health Network - Multiple Sclerosis Clinic

    Saint John, New Brunswick, E2L 4L2

  • St. Michael's Hospital MS Clinic, MS Research Centre

    Toronto, Ontario

  • MS Clinic Mauricie Bois Francs

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

About this study

Official title: An Open-Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment

This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up to 96 weeks). Anticipated time on study treatment is 96 weeks.

Read the detailed description

Participants who complete their Week 72 ocrelizumab infusion and do not experience any serious infusion related reaction (IRR) throughout the main study will be eligible to enroll in an optional, open-label, non-randomized substudy to MN30035 and receive one additional shorter infusion of ocrelizumab at the Week 96 visit. This substudy will enroll approximately 100 patients from MN30035 main study.

Being tested
Ocrelizumab
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

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 ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks).

  • OcrelizumabDrug

    Also called RO4964913

    Participants will receive an additional single 600-mg dose IV infusion at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)

Study groups in NCT02637856
Study groupRoleWhat they receive
OcrelizumabExperimentalParticipants will receive ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks).
Receives: Drug: Ocrelizumab
Ocrelizumab (substudy)ExperimentalParticipants with no serious IRR throughout the main study will be eligible to enroll in an optional substudy and receive one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab will be administered IV as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)
Receives: Drug: Ocrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period

    Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 gadolinium (Gd)-enhanced lesion on brain magnetic resonance imaging (MRI) or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.

    Measured: Baseline up to Week 96

  2. Percentage of Participants With Infusion Related Reactions (IRRs) in Optional Substudy

    Rate and frequency of Grade 3 or 4 IRRs with onset on or after the shorter ocrelizumab infusion

    Measured: Week 96 to Week 100

Secondary outcomes (11)

  1. Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week Period

    Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.

    Measured: Baseline up to Weeks 24 and 48

  2. Time to Protocol-Defined Event

    Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.

    Measured: Baseline up to Week 96

  3. Total Number of Protocol-Defined Relapses Per Participant Year During 96-week Period

    Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for greater than (>) 24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days. The Adjusted Annualized Relapse Rate was adjusted by baseline Expanded Disability Status Scale (EDSS <2.5 vs. >=2.5) and number of previous disease-modifying treatments (DMTs =1 vs. >1)

    Measured: Baseline up to Week 96

  4. Time to Onset of First Protocol-Defined Relapse

    Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for >24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days.

    Measured: Baseline up to Week 96

  5. Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI

    Measured: Baseline up to Week 96

  6. Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI

    Measured: Baseline up to Week 96

  7. Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score

    Measured: Baseline up to Week 96

  8. Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI

    The analyses included participants who had an interpretable MRI at the time point of interest. Participants having 0, 1, 2, 3, and greater than 3 lesions at weeks 24, 48, and 96 were included in the analysis.

    Measured: Weeks 24, 48, and 96

  9. Change From Baseline in Total T2 Lesion Volume as Detected by Brain MRI

    Baseline data is represented as mean; post-Baseline date are represented as mean changes.

    Measured: Baseline, Weeks 24, 48, and 96

  10. Total Number of New and/or Enlarging T2 Lesions as Detected by Brain MRI

    Measured: Weeks 24, 48, and 96

  11. Percentage of Participants With Adverse Events

    An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: Baseline up to 100 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2015 (estimated)
  2. Study start11 Feb 2016
  3. Primary completion3 May 2019
  4. Study completion3 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
608 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02637856
Sponsor's protocol ID
MN30035
Status last verified
May 2020
First submitted
18 Dec 2015
Last updated
26 May 2020
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Vermersch P, Benedict RHB, Van Wijmeersch B, Cutter G, Kister L, Oreja-Guevara C, Siva A, Wiendl H, Wuerfel J, El Azzouzi B, Kuenzel T, Buffels R, Craveiro L, Dirks P, Comi G. Efficacy and Safety of Patients With Relapsing Multiple Sclerosis Switching to Ocrelizumab Due to Suboptimal Treatment Response: Results of the 4-Year CASTING-LIBERTO Trial. Eur J Neurol. 2026 Jun;33(6):e70628. doi: 10.1111/ene.70628.

    PubMed 42328798

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ocrelizumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Genentech, Inc. at 82 sites in 2 countries.

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: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Canada. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period (time frame: Baseline up to Week 96). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02637856, which also lists 1 linked publication.

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 26 May 2020.

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