Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Ocrelizumab

• Registration Number: NCT04855617
• Lead Sponsor: NYU Langone Health

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-26
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-22
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Receiving Multiple Sclerosis care	Ocrelizumab	Patients currently receiving ocrelizumab or initiating ocrelizumab per their MS treating physician.

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life in Neurologic Disorders (NeuroQoL) Scores	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

Name	Time	Method
Change in Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS) Scores	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.
Change in SymptoMScreen (SyMS) Scores	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.

Trial Locations

Locations (2)

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