Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis

NYU Langone Health

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Ocrelizumab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04855617

20-00041

Details and patient eligibility

About

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

Enrollment: 122 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

122 participants in 1 patient group

Patients Receiving Multiple Sclerosis care

Description:

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

Treatment:

Drug: Ocrelizumab