Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04855617|
Recruitment Status : Active, not recruiting
First Posted : April 22, 2021
Last Update Posted : April 12, 2022
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Drug: Ocrelizumab|
|Study Type :||Observational|
|Actual Enrollment :||122 participants|
|Official Title:||Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis|
|Actual Study Start Date :||October 26, 2020|
|Estimated Primary Completion Date :||August 30, 2022|
|Estimated Study Completion Date :||August 30, 2022|
Patients Receiving Multiple Sclerosis care
Patients currently receiving ocrelizumab or initiating ocrelizumab per their MS treating physician.
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.
Other Name: OCREVUS
- 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.
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04855617
|United States, Massachusetts|
|Elliot Lewis Center for Multiple Sclerosis Care|
|Wellesley, Massachusetts, United States, 02481|
|United States, New York|
|NYU Langone Health Multiple Sclerosis Comprehensive Care Center (NYULH MSCCC)|
|New York, New York, United States, 10016|
|Principal Investigator:||Ilya Kister, MD||NYU Langone Health|