Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04855617
• Other study ID #: 20-00041
• Status: Completed
• Start date: October 26, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: June 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone Health Multiple Sclerosis Comprehensive Care Center (NYULH MSCCC)	New York	New York
United States	Elliot Lewis Center for Multiple Sclerosis Care	Wellesley	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in SymptoMScreen (SyMS) Scores	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.	Week 4, Week 22
Secondary	Change in Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS) Scores	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.	Week 4, Week 22