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Trial record 3 of 26 for:    ocrelizumab

Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)

This study is currently recruiting participants.
Verified August 2017 by Hoffmann-La Roche
Sponsor:
ClinicalTrials.gov Identifier:
NCT03085810
First Posted: March 21, 2017
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks.

Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting Drug: Ocrelizumab Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Time to Onset of Confirmed Disability Progression (CDP) Sustained fo at Least 24 and 48 Weeks, As Measured Using Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline up to 4 years ]
  • Percentage of Participants With Confirmed Disability Improvement (CDI) at Year 1, As Measured Using EDSS [ Time Frame: Year 1 ]
  • Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 1, As Measured Using EDSS [ Time Frame: Year 1 ]
  • Percentage of Participants With CDI at Year 2, As Measured Using EDSS [ Time Frame: Year 2 ]
  • Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 2, As Measured Using EDSS [ Time Frame: Year 2 ]
  • Percentage of Participants With CDI at Year 4, As Measured Using EDSS [ Time Frame: Year 4 ]
  • Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 4, As Measured Using EDSS [ Time Frame: Year 4 ]
  • Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 1, As Measured Using EDSS [ Time Frame: Year 1 ]
  • Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 2, As Measured Using EDSS [ Time Frame: Year 2 ]
  • Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 3, As Measured Using EDSS [ Time Frame: Year 3 ]
  • Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 4, As Measured Using EDSS [ Time Frame: Year 4 ]
  • Mean Change From Baseline in EDSS Score at Week 24 [ Time Frame: Baseline, Week 24 ]
  • Mean Change From Baseline in EDSS Score at Week 48 [ Time Frame: Baseline, Week 48 ]
  • Mean Change From Baseline in EDSS Score at Week 72 [ Time Frame: Baseline, Week 72 ]
  • Mean Change From Baseline in EDSS Score at Week 96 [ Time Frame: Baseline, Week 96 ]
  • Mean Change From Baseline in EDSS Score at Week 120 [ Time Frame: Baseline, Week 120 ]
  • Mean Change From Baseline in EDSS Score at Week 144 [ Time Frame: Baseline, Week 144 ]
  • Mean Change From Baseline in EDSS Score at Week 168 [ Time Frame: Baseline, Week 168 ]
  • Mean Change From Baseline in EDSS Score at Week 192 [ Time Frame: Baseline, Week 192 ]
  • Time to First Protocol-Defined Event of Disease Activity [ Time Frame: Baseline up to 4 years ]
    Protocol-defined event of disease activity is defined as having at least one of the following: (1). protocol defined relapse (occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis [MS], as determined using EDSS/Functional Systems Score [FSS] assessment). (2). CDP, as determined using EDSS. (3). a T1 Gd-enhanced lesion after Week 8 (4). a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI) after Week 8 compared to the Week 8 MRI scan.

  • Time to First Relapse [ Time Frame: Baseline up to 4 years ]
    Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.

  • Annualized Relapse Rate [ Time Frame: Baseline up to 4 years ]
    Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.


Secondary Outcome Measures:
  • Percentage of Participants Who Are Relapse Free [ Time Frame: Weeks 48, 96, 144, 192 ]
    Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.

  • Percentage of Participants With No Evidence of Protocol Defined Disease Activity [ Time Frame: Weeks 96, 144, 192 ]
    Protocol-defined disease activity is defined as having at least one of the following: (1). protocol defined relapse (occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis [MS], as determined using EDSS/Functional Systems Score [FSS] assessment). (2). CDP, as determined using EDSS. (3). a T1 Gd-enhanced lesion after Week 8. (4). a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI) after Week 8 compared to the Week 8 MRI scan.

  • Percentage of Participants With no Evidence of Progression (NEP) [ Time Frame: Weeks 96, 192 ]
    NEP is defined as no progression sustained for at least 24 weeks on all of the following three components (CDP; 20 percent [%] increase from baseline in timed 25 Foot Walk Test [T25FWT]; 20% increase from baseline in timed 9 hole peg test [9HPT]). CDP will be assessed using EDSS.

  • Percentage of Participants With no Evidence of Progression Sustained for At Least 24 Weeks and no Active Disease (NEPAD) [ Time Frame: Weeks 96, 192 ]
    NEPAD is defined as no progression on all of the three components of NEP (CDP, T25FWT, 9HPT), no new relapse and no enlarging or new T2 or T1 Gd-enhancing lesion. CDP will be assessed using EDSS. Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.

  • Change from Baseline in Multiple Sclerosis Functional Composite (MSFC) Total Score [ Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192 ]
  • Change from Baseline in MSFC Composite (T25FW) Score [ Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192 ]
  • Change from Baseline in MSFC Composite (9HPT) Score [ Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192 ]
  • Change from Baseline in MSFC Composite (Paced Auditory Serial Addition Test [PASAT]) Score [ Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192 ]
  • Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI [ Time Frame: Baseline, Weeks 8, 24, 48, 96, 144, 192 ]
  • Total Number of New and/or Enlarging T2 Lesion as Detected by Brain MRI [ Time Frame: Baseline, Weeks 8, 24, 48, 96, 144, 192 ]
  • Change from baseline in total T1 hypointense lesion volume as Detected by Brain MRI [ Time Frame: Baseline, Weeks 8, 24, 48, 96, 144, 192 ]
  • Total Number of Fluid-Attenuated Inversion-Recovery (FLAIR) Lesion as Detected by Brain MRI [ Time Frame: Baseline, Weeks 8, 24, 48, 96, 144, 192 ]
  • Change From Baseline in Brain Volume as Detected by Brain MRI [ Time Frame: Baseline, Weeks 8, 24, 48, 96, 144, 192 ]
  • Time to Treatment Discontinuation [ Time Frame: Baseline up to 4 years ]
  • Employment Status: Work Productivity and Activity Impairment Questionnaire (WAPI) Score [ Time Frame: Baseline, Weeks 24, 48, 96, 120, 144, 192 ]
  • SymptoMScreen Composite Score [ Time Frame: Baseline, Weeks 24, 48, 96, 120, 144, 192 ]
  • Quality of Life: Multiple Sclerosis Impact Scale (MSIS)-29 Questionnaire Score [ Time Frame: Baseline, Weeks 24, 48, 96, 120, 144, 192 ]
  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 4 years ]
    Short term safety related to the infusion (infusion-related reactions [IRRs], during infusion and up to 24h after) the overall safety is measured continuously at clinical visits and including every 8 week telephone visits up to 48 weeks post study.


Estimated Enrollment: 600
Actual Study Start Date: March 27, 2017
Estimated Study Completion Date: January 19, 2022
Estimated Primary Completion Date: January 19, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ocrelizumab
Ocrelizumab will be administered intravenously (IV) as two 300-milligram (mg) infusions (infusion length=2.5 hours) on Days 1 and 15, followed by one 600-mg infusion dose every 24 weeks for a maximum of 8 doses throughout the 192 weeks treatment period.
Drug: Ocrelizumab
Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria
  • Have a length of disease duration, from first documented clinical attack consistent with MS disease of less than or equal to (</=) 3 years
  • Within the last 12 months one or more clinically reported relapse(s) or one or more signs of MRI activity
  • EDSS of 0.0 to 3.5 inclusive, at screening
  • An agreement to use an acceptable birth control method for women of childbearing potential, during the treatment period and for at least 6 months after the last dose of study drug

Exclusion Criteria:

  • Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing MS
  • Inability to complete an MRI
  • Known presence of other neurological disorders

Exclusions Related to General Health:

  • Pregnancy or lactation
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History or currently active primary or secondary immunodeficiency
  • Lack of peripheral venous access
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study
  • Congestive heart failure (New York Heart Association [NYHA] III or IV functional severity)
  • Known active bacterial, viral, fungal, mycobacterial infection or other infection, (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks prior to screening or oral antibiotics 2 weeks prior to screening
  • History of malignancy, major opportunistic infections, alcohol or drug abuse, recurrent or chronic infection, and/or coagulation disorders

Exclusions Related to Medications:

  • Received any prior approved disease modifying treatment (DMT) with a label for MS, for example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab, fingolimod, teiflunomide and dimethylfumarate
  • Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the baseline visit
  • Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
  • Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic therapies (cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, cladribine, mitoxantrone, laquinimod, total body irradiation, or bone marrow transplantation)
  • Treatment with investigational DMT
  • Treatment with fampridine/dalfamipridine unless on stable dose for >/=30 days prior to screening
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085810


Contacts
Contact: Reference Study ID: MA30143 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S and Canada) global-roche-genentech-trials@gene.com

  Show 234 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03085810     History of Changes
Other Study ID Numbers: MA30143
2016-002937-31 ( EudraCT Number )
First Submitted: March 16, 2017
First Posted: March 21, 2017
Last Update Posted: August 28, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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


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