Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis

Sponsor

NYU Langone Health (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04855617

Collaborator

Genentech, Inc. (Industry)

122

Enrollment

Locations

22.1

Anticipated Duration (Months)

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Ocrelizumab

Study Design

Study Type:

Observational

Actual Enrollment :

122 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis

Actual Study Start Date :

Oct 26, 2020

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients Receiving Multiple Sclerosis care Patients currently receiving ocrelizumab or initiating ocrelizumab per their MS treating physician.	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 Other Names: OCREVUS

Arm

Intervention/Treatment

Patients Receiving Multiple Sclerosis care

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

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

Other Names:

OCREVUS

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elliot Lewis Center for Multiple Sclerosis Care	Wellesley	Massachusetts	United States	02481
2	NYU Langone Health Multiple Sclerosis Comprehensive Care Center (NYULH MSCCC)	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health
Genentech, Inc.

Investigators

Principal Investigator: Ilya Kister, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT04855617

Other Study ID Numbers:

20-00041

First Posted:

Apr 22, 2021

Last Update Posted:

Apr 12, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Ocrelizumab

Study Results

No Results Posted as of Apr 12, 2022