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A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis (CONSONANCE)

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ClinicalTrials.gov Identifier: NCT03523858
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

Condition or disease Intervention/treatment Phase
Progressive Multiple Sclerosis (PMS) Drug: Ocrelizumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : September 29, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Arm Intervention/treatment
Experimental: Ocrelizumab
Ocrelizumab will be administered via intravenous (IV) infusion.
Drug: Ocrelizumab
Ocrelizumab will be administered via intravenous (IV) infusion at an initial dose of two 300-mg infusions separated by 14 days (on Days 1 and 15), and then 600 mg at every subsequent dose every 24 weeks for the remainder of the study treatment period (approximately 192 weeks)




Primary Outcome Measures :
  1. Proportion of Participants with No Evidence of Progression (NEP) [ Time Frame: Baseline to Week 192 ]
    NEP is defined as no progression sustained for at least 24 weeks on confirmed disability progression (CDP, as measured by the EDSS), ≥20% increase in timed 25-foot walk test (T25FWT), and ≥20% increase in nine-hole peg test (9HPT).

  2. Proportion of Participants with NEP Sustained For At Least 24 Weeks and No Active Disease (NEPAD) [ Time Frame: Baseline to Week 192 ]
    NEPAD is defined as no progression on all of the three components of NEP (CDP as measured by the EDSS), no protocol-defined relapse, no enlarging or new T2 lesion, and no T1 gadolinium (Gd)-enhancing lesion


Secondary Outcome Measures :
  1. Change from Baseline in Cognitive Function, as Measured by the Symbol Digit Modalities Test (SDMT) [ Time Frame: Baseline to end of study (Week 192) ]
  2. Change from Baseline in Patient-Reported Outcomes (PROs) [ Time Frame: Baseline to end of study (Week 192) ]
    PROs collected in this study will be the Multiple Sclerosis Impact Scale (MSIS-29), the Multiple Sclerosis Walking scale (MSWS-12), the ABILHAND Questionnaire, and the Fatigue Scale for Motor and Cognitive function (FSMC)

  3. Mean Change from Baseline in the Expanded Disability Status Scale (EDSS) score over the course of the study [ Time Frame: Baseline to end of study (Week 192) ]
  4. Time to Onset of First Confirmed Disability Progression (CDP) Sustained For At Least 24 Weeks [ Time Frame: Baseline to onset of first CDP (as measured by EDSS) sustained for at least 24 weeks ]
  5. Time to Onset of First >=20% Increase in Timed 25-foot Walk Test (T25FWT) Sustained For At Least 24 Weeks [ Time Frame: Baseline to onset of first >=20% increase in T25FWT sustained for at least 24 weeks ]
  6. Time to Onset of First >=20% Increase in 9 Hole Peg Test (9HPT) Sustained For At Least 24 Weeks [ Time Frame: Baseline to onset of first >=20% increase in 9HPT sustained for at least 24 weeks ]
  7. Proportion of Participants with NEP [ Time Frame: Week 24 to Week 96, Week 24 to Week 192, and Week 48 to Week 192 ]
  8. Proportion of Participants with NEPAD [ Time Frame: Week 24 to Week 96, Week 24 to Week 192, Week 48 to Week 192 ]
  9. Time to Treatment or Study Discontinuation [ Time Frame: Baseline to week 192 ]
  10. Change in Whole Brain Volume [ Time Frame: Baseline to end of study (Week 192) ]
  11. Change in Cortical Gray Matter Volume [ Time Frame: Baseline to end of study (Week 192) ]
  12. Change in Total T2 Lesion Volume [ Time Frame: Baseline to end of study (Week 192) ]
  13. Change in Slowly Evolving Lesions (SEL) [ Time Frame: Baseline to end of study (Week 192) ]
  14. Change in Total T1 Gadolinium (Gd)+ Lesion [ Time Frame: 'Baseline to end of study (Week 192) ]
  15. Measurement of T1 Gd-enhancement in New Focal T2 Lesions, SELs, Persistent Areas of Non-SEL T2 Lesions, and Normal-Appearing Brain Tissue [ Time Frame: Baseline to end of study (Week 192) ]
  16. Change in Cerebral White Matter Volume [ Time Frame: Baseline to end of study (Week 192) ]
  17. Change in Gd-enhancing Fluid-Attenuated Inversion-Recovery (FLAIR) Meningeal Lesions [ Time Frame: Baseline to end of study (Week 192) ]
  18. Spectroscopic MR: Measure of the Relative Signal Amplitude of N-Acetyl Aspartate (NAA), and Choline to Creatine [ Time Frame: 'Baseline to end of study (Week 192) ]
    Only in centers with 1.5-Tesla MRI capable to perform it

  19. Measure of Phase Rim Lesions by T2* [ Time Frame: 'Baseline to end of study (Week 192) ]
    Only in centers with 3-Tesla MRI capable to perform it, where this sequence would replace the spectroscopic MR in the acquisition flow

  20. Change in Brain Tissue Integrity as Measured by Signal Mass Analysis [ Time Frame: 'Baseline to end of study (Week 192) ]
  21. Precentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline to end of study (Week 192) ]

Other Outcome Measures:
  1. Change in smartphone-based Floodlight remote patient monitoring (RPM) Test Battery [ Time Frame: Baseline to Week 48 and baseline to end of study (Week 192) ]

    Floodlight RPM Test Battery encompasses the following measures:

    • Information processing speed (IPS) test
    • Draw a Shape Test
    • Pinching Test
    • 2-Minute Walking test (2MWT)
    • U-Turn test (UTT)
    • Static balance test (SBT)
    • Continuous sensor-based passive Analysis of mobility and Gait-related motion (CAG)
    • Daily Mood Questions (DMQ)
    • Smartphone version of MSIS-29
    • MS Symptom Tracker (MSST)

    During the first 48 weeks of the study, patient will be randomized according to the following two assessment groups to which patients will be randomly allocated in 3:1 ration:

    • Group 1 will receive a preconfigured and locked-in smartphone and will use the Floodlight RPM solution installed on the smartphone (n=450)
    • Group 2 will not receive a smartphone and will not use the Floodlight RPM solution (n=150) From Week 48 to 192, all study participants (n=600) will use the Floodlight RPM solution'



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a length of disease duration since Progressive Multiple Sclerosis (PMS) disease symptom onsent <= 10 years if baseline Expanded Disability Status Scale (EDSS) <=5.0 and <=15 years if baseline EDSS >5.0
  • Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers.
  • For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug.
  • EDSS (Expanded Disability Status Scale) ≤6.5 at screening
  • Have a documented evidence of disability progression independent of relapse at any point in time over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician's judgment

Exclusion Criteria:

  • Gadolinium (Gd) intolerance
  • Known presence of other neurological disorders Exclusions Related to General Health
  • Any concomitant disease that may require chronic treatment of systemic corticosteroids or immunosuppressants during the course of the study
  • History or currently active primary or secondary immunodeficiency
  • Lack of peripheral venous access
  • Hypersensitivity to ocrelizumab or to any of its excipients
  • Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study.
  • Active infections must be treated and resolved before possible inclusion in the study.
  • Participants in a severely immunocompromised state until the condition resolves
  • Participants with known active malignancies or being actively monitored for recurrence of malignancy
  • Participants who have or have had confirmed progressive multifocal leukoencephalopathy (PML)

Exclusions Related to Medications

  • All vaccines should be given at least 6 weeks before the first infusion of ocrelizumab. Live/live attenuated vaccines should be avoided during treatment and safety follow-up period until B cells are peripherally repleted.
  • Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five halflives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS
  • Previous treatment with B-cell targeted therapies, alemtuzumab, total body irradiation, or bone marrow transplantation
  • Previous treatment with natalizumab, daclizumab or figolimod in the last 8 weeks.
  • Previous treatment with natalizumab where PML has not been excluded according to specific algorithm
  • Participants previously treated with teriflunomide, unless an accelerated elimination procedure is implemented until its completion before screening visit
  • Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks.
  • Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 96 weeks.
  • Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label
  • Treatment with fampridine/dalfampridine (Fampyra)/Ampyra) or other symptomatic MS treatment unless on stable dose for ≥30 days prior to screening.

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): NCT03523858


Contacts
Contact: Reference Study ID Number: MN39159 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03523858     History of Changes
Other Study ID Numbers: MN39159
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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