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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03085810
Recruitment Status : Active, not recruiting
First Posted : March 21, 2017
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 16, 2017
First Posted Date  ICMJE March 21, 2017
Last Update Posted Date May 28, 2020
Actual Study Start Date  ICMJE April 4, 2017
Estimated Primary Completion Date August 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
  • Time to Onset of Confirmed Disability Progression (CDP) Sustained for 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.
  • Proportion of Participants with Infusion Related Reactions (IRRs) Occurring During or Within 24 Hours Following the First Infusion After Randomization to the Shorter Infusion Substudy [ Time Frame: From Week 24 through Week 192 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
  • 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 Timed 25 Foot Walk Test (T25FW) Score [ Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192 ]
  • Change from Baseline in MSFC Composite 9 Hole Peg Test (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 ]
  • Change from baseline in cognitive performance as measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) [ 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.
  • Proportion of Participants with IRR (overall) in the Shorter Infusion Substudy [ Time Frame: From Week 24 through Week 192 ]
  • Proportion of Participants with IRR By Dose at Randomization in the Shorter Infusion Substudy [ Time Frame: From Week 24 through Week 192 ]
  • Proportion of Participants with IRRs Leading to Treatment Discontinuation in the Shorter Infusion Substudy [ Time Frame: From Week 24 through Week 192 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
  • 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 Gdenhancing 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 T1 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 continously at clinical visits and including every 8 week telephone visits up to 48 weeks post study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)
Official Title  ICMJE An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis
Brief Summary

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.

The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis, Relapsing-Remitting
Intervention  ICMJE Drug: Ocrelizumab
Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ocrelizumab
  • Active Comparator: Substudy Group 1
    At week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 3.5 hours every 24 weeks for the remainder of the study duration
    Intervention: Drug: Ocrelizumab
  • Experimental: Substudy Group 2
    At week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 2 hours followed by sodium chloride given as a slow infusion over the remaining 1.5 hours to mimic the standard-length infusion (3.5 hour) every 24 weeks for the remainder of the study duration
    Intervention: Drug: Ocrelizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 26, 2020)
1225
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2017)
600
Estimated Study Completion Date  ICMJE August 15, 2024
Estimated Primary Completion Date August 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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 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 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

Exclusion related to Shorter Infusion Substudy:

- Any previous serious IRRs experienced with ocrelizumab treatment

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Croatia,   Denmark,   France,   Germany,   Hungary,   Italy,   Kuwait,   Lebanon,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Romania,   Slovakia,   Slovenia,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries Finland
 
Administrative Information
NCT Number  ICMJE NCT03085810
Other Study ID Numbers  ICMJE MA30143
2016-002937-31 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP