Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis

NCT04855617 | Completed FDA Drug

• 1 other identifier: 20-00041
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in SymptoMScreen (SyMS) Scores

  Week 4, Week 22

• Change in Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS) Scores

  Week 4, Week 22

Study Arms (1)

Patients Receiving Multiple Sclerosis care

Patients currently receiving ocrelizumab or initiating ocrelizumab per their MS treating physician.

Drug: Ocrelizumab

Interventions

Ocrelizumab DRUG

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

Also known as: OCREVUS

Patients Receiving Multiple Sclerosis care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Elliot Lewis Center for Multiple Sclerosis Care

Wellesley, Massachusetts, 02481, United States

Location

NYU Langone Health Multiple Sclerosis Comprehensive Care Center (NYULH MSCCC)

New York, New York, 10016, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Study-specific biospecimens (peripheral venous blood) will be collected.

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ilya Kister, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: October 26, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

US (2)