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Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02688985
First received: February 18, 2016
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
This is an open-label, multicenter, biomarker study designed to be hypothesis-generating in order to better understand the mechanism of action of ocrelizumab and B-cell biology in RMS. Ocrelizumab will be administered as two intravenous (IV) infusions of 300 milligrams (mg) on Days 1 and 15. Subsequent doses will be given as single 600-mg infusions. Participants will be randomized to receive lumbar puncture (LP) post-treatment at Week 12, 24, or 52.

Condition Intervention Phase
Relapsing Multiple Sclerosis
Drug: Ocrelizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Patients With Relapsing Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Change from Baseline in Neurofilament Light (NfL) Levels in Cerebrospinal Fluid (CSF) Post-Treatment with Ocrelizumab [ Time Frame: From Baseline to post-treatment (Week 12, 24, or 52 according to randomization) ] [ Designated as safety issue: No ]
  • Change from Baseline in Cluster of Differentiation (CD) 19+ B-Cells in CSF Post-Treatment with Ocrelizumab [ Time Frame: From Baseline to post-treatment (Week 12, 24, or 52 according to randomization) ] [ Designated as safety issue: No ]
  • Change from Baseline in CD3+ T-Cells in CSF Post-Treatment with Ocrelizumab [ Time Frame: From Baseline to post-treatment (Week 12, 24, or 52 according to randomization) ] [ Designated as safety issue: No ]

Estimated Enrollment: 99
Study Start Date: April 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ocrelizumab + LP at Week 12
Participants with RMS will receive ocrelizumab as two 300-mg IV infusions on Days 1 and 15 then as single infusions of 600 mg every 24 weeks thereafter for a maximum of three doses. LP will be performed at Week 12 to obtain CSF samples for the primary study assessment.
Drug: Ocrelizumab
Participants with RMS will receive ocrelizumab as two 300-mg IV infusions on Days 1 and 15 then as single infusions of 600 mg every 24 weeks thereafter for a maximum of three doses.
Other Name: RO4964913
Experimental: Ocrelizumab + LP at Week 24
Participants with RMS will receive ocrelizumab as two 300-mg IV infusions on Days 1 and 15 then as single infusions of 600 mg every 24 weeks thereafter for a maximum of three doses. LP will be performed at Week 24 (pre-dose) to obtain CSF samples for the primary study assessment.
Drug: Ocrelizumab
Participants with RMS will receive ocrelizumab as two 300-mg IV infusions on Days 1 and 15 then as single infusions of 600 mg every 24 weeks thereafter for a maximum of three doses.
Other Name: RO4964913
Experimental: Ocrelizumab + LP at Week 52
Participants with RMS will receive ocrelizumab as two 300-mg IV infusions on Days 1 and 15 then as single infusions of 600 mg every 24 weeks thereafter for a maximum of three doses. LP will be performed at Week 52 to obtain CSF samples for the primary study assessment.
Drug: Ocrelizumab
Participants with RMS will receive ocrelizumab as two 300-mg IV infusions on Days 1 and 15 then as single infusions of 600 mg every 24 weeks thereafter for a maximum of three doses.
Other Name: RO4964913

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of RMS in accordance with the 2010 revised McDonald criteria
  • Expanded Disability Status Scale (EDSS) score of 0 to 5.5 points, inclusive, at Screening
  • Disease duration from the onset of multiple sclerosis symptoms less than (<) 15 years in participants with an EDSS score greater than (>) 5.0 at Screening
  • Either treatment-naive or receiving treatment with disease-modifying therapies, including prior use of interferon (IFN)-beta-1a (Avonex®, Rebif®), IFN-beta-1b (Betaseron®/Betaferon), or glatiramer acetate (Copaxone®).
  • At least one clinically documented relapse in the past year and/or at least one T1-weighted Gadolinium (Gd)-enhancing lesion in the past year and/or at least one new T2 lesion in the past year at the time of enrollment
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <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:

  • Diagnosis of primary progressive multiple sclerosis (PPMS)
  • Diagnosis of secondary progressive multiple sclerosis (MS) without relapses for at least 1 year
  • History or known presence of recurrent or chronic infection (human immunodeficiency virus [HIV], syphilis, tuberculosis)
  • 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)
  • Known presence or history of other neurologic disorders
  • Contraindications or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label
  • Contraindication for LP
  • Previous treatment with B cell-targeted therapies (such as rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
  • Previous treatment with natalizumab/Tysabri®, alemtuzumab, anti-CD4 agents, cladribine, teriflunomide, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
  • Treatment with fingolimod/Gilenya®, dimethyl fumarate/Tecfidera®, or similar treatment within 6 months prior to enrollment
  • Systemic corticosteroid therapy within 4 weeks prior to Baseline
  • Previous or concurrent treatment with any investigational agent or treatment with any experimental procedure for MS (such as treatment for chronic cerebrospinal venous insufficiency)
  • Certain laboratory abnormalities or findings at Screening
  • Pregnant or lactating, or intending to become pregnant during the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02688985

Contacts
Contact: Reference Study ID Number: ML29966 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
United States, California
Not yet recruiting
Palo Alto, California, United States, 94305
Recruiting
San Francisco, California, United States, 94115
United States, Colorado
Not yet recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Recruiting
New Haven, Connecticut, United States, 06510
United States, Massachusetts
Recruiting
Worcester, Massachusetts, United States, 01655
United States, Missouri
Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Recruiting
Latham, New York, United States, 12210
United States, North Carolina
Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Not yet recruiting
Dallas, Texas, United States, 75390
Canada, Alberta
Not yet recruiting
Edmonton, Alberta, Canada, T6G1Z1
Canada, British Columbia
Not yet recruiting
Vancouver, British Columbia, Canada, V6T 1Z3
Canada, Quebec
Not yet recruiting
Montreal, Quebec, Canada, H3A 2B4
Germany
Not yet recruiting
Dresden, Germany, 01307
Not yet recruiting
Göttingen, Germany, 37075
Sweden
Recruiting
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02688985     History of Changes
Other Study ID Numbers: ML29966  2015-004616-37 
Study First Received: February 18, 2016
Last Updated: November 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on December 02, 2016