Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis

NCT ID: NCT04855617

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2022-10-01

Brief Summary

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

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients Receiving Multiple Sclerosis care

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

Ocrelizumab

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

OCREVUS

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilya Kister, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

Elliot Lewis Center for Multiple Sclerosis Care

Wellesley, Massachusetts, United States

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

New York, New York, United States

Countries

United States

Other Identifiers

20-00041

Identifier Type: -

Identifier Source: org_study_id