Symptom Burden in Patients Treated With… | Clinical Trial

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Elliot Lewis Center for Multiple Sclerosis Care, Wellesley, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocrelizumab

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

Other names: OCREVUS

Primary outcomes

Change in Quality of Life in Neurologic Disorders (NeuroQoL) Scores

Time frame: 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 outcomes

Change in SymptoMScreen (SyMS) Scores

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

Genentech, Inc.

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Apr 22, 2021
Registry last updated: Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed