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Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT04855617
Recruitment Status : Active, not recruiting
First Posted : April 22, 2021
Last Update Posted : May 12, 2021
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This study is designed to determine whether symptom burden differs by time to infusion.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Ocrelizumab

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Study Type : Observational
Actual Enrollment : 122 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Group/Cohort Intervention/treatment
Patients Receiving Multiple Sclerosis care
Patients currently receiving ocrelizumab or initiating ocrelizumab per their MS treating physician.
Drug: Ocrelizumab

Administer Ocrelizumab under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage severe reactions such as serious infusion reactions.

  • Initial dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion.
  • Subsequent doses: single 600 mg intravenous infusion every 6 months.
  • Observe the patient for at least one hour after the completion of the infusion
Other Name: OCREVUS




Primary Outcome Measures :
  1. Change in Quality of Life in Neurologic Disorders (NeuroQoL) Scores [ Time Frame: Week 4, Week 22 ]
    The NeuroQoL short form will be used for this study, which consists of 5 statements on how much difficulty one currently has during certain activities. Each statement is answered on a scale of 1 (cannot do) to 5 (none); the total range of score is 1-25. The higher the score, the less difficulty one has.


Secondary Outcome Measures :
  1. Change in SymptoMScreen (SyMS) Scores [ Time Frame: Week 4, Week 22 ]
    SyMS consists of 12 questions. Participants are asked to choose a response that best describes how each MS symptom has affected everyday life activities. Each questions is answered on a scale of 0 (not affected at all) to 6 (total limitation/I'm unable to do most daily activities); the total range of score is 0-72. The higher the score, the higher the limitation from MS symptoms.

  2. Change in Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS) Scores [ Time Frame: Week 4, Week 22 ]
    There are 2 questions that are quantifiable - they pertain to how much MS has affected one's productivity while working or ability to do regular daily activities. The questions are answered on a scale of 0 (no effect) to 10 (complete prevention); the total range of score is 0-20. The higher the score, the higher the level of prevention.


Biospecimen Retention:   Samples With DNA
Study-specific biospecimens (peripheral venous blood) will be collected.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving Multiple Sclerosis care at the NYU Comprehensive MS Care Center or the Elliot Lewis MS Center will be recruited. A clinical list of patients currently receiving ocrelizumab, or potentially starting ocrelizumab will be screened for study inclusion/exclusion criteria.
Criteria

Inclusion Criteria:

  • Age 18-80
  • Diagnosis of multiple sclerosis (revised 2017 criteria)
  • EDSS 0-7
  • Plans to initiate treatment with ocrelizumab within 6 months or has been on an approved regimen of ocrelizumab for >12 months as part of their clinical care
  • Individual must be able to provide consent, read/write/comprehend English Language

Exclusion Criteria:

  • Clinical relapse within 3 months of first on-study infusion
  • Cognitive impairment limiting the ability to consent or fill out the electronic survey
  • Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
  • Untreated psychiatric illness (such as major depressive disorder, Bipolar disorder, psychotic disorder, schizophrenia)
  • Active substance abuse disorder
  • Significant medical comorbidities (such as history of severe traumatic brain injury, stroke, systemic cancer or chronic infection)
  • Chemotherapy use within 6 months of first study infusion
  • Prior treatment with alemtuzumab within 12 months of first study infusion
  • Prior treatment with a B-cell depleting therapy other than ocrelizumab within 12 months of first on-study infusion

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): NCT04855617


Locations
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United States, Massachusetts
Elliot Lewis Center for Multiple Sclerosis Care
Wellesley, Massachusetts, United States, 02481
United States, New York
NYU Langone Health Multiple Sclerosis Comprehensive Care Center (NYULH MSCCC)
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Genentech, Inc.
Investigators
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Principal Investigator: Ilya Kister, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04855617    
Other Study ID Numbers: 20-00041
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021

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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:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs