Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis

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

Study Description

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

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Ilya Kister, MD; NYU Langone Health

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04855617
• Other Study ID Numbers: 20-00041
• First Posted: April 22, 2021
• Last Update Posted: May 12, 2021
• Last Verified: May 2021

• 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:

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