Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Ocrelizumab

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Wellesley, Massachusetts, United States, 02481
      • Elliot Lewis Center for Multiple Sclerosis Care
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health Multiple Sclerosis Comprehensive Care Center (NYULH MSCCC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: OCREVUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life in Neurologic Disorders (NeuroQoL) Scores	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.	Week 4, Week 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SymptoMScreen (SyMS) Scores	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.	Week 4, Week 22
Change in Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS) Scores	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.	Week 4, Week 22

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Ilya Kister, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Immunologic Factors; Ocrelizumab
• Other Study ID Numbers: 20-00041

Drug and device information, study documents

• 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