MS PATHS COVID-19 Questionnaire Data Linkage Sub-Study
Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS) - COVID-19 Questionnaire Linkage Sub-Study
1 other identifier
observational
1,507
1 country
6
Brief Summary
The primary objective of this sub-study is to supplement the Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS) dataset with coronavirus disease 2019 (COVID-19)-related health information obtained from periodic participant questionnaires administered by participating MS PATHS institutions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2020
CompletedFirst Submitted
Initial submission to the registry
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
September 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2021
CompletedApril 18, 2023
April 1, 2023
10 months
September 27, 2021
April 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Completed COVID-19 Questionnaires Able to be Linked to a MS PATHS Participant Identifier (ID)
Up to 17 months
Study Arms (1)
Cohort 1
Participants with multiple sclerosis (MS) or clinically isolated syndrome (CIS) who are enrolled in MS PATHS under Study 888MS001 and have completed at least one COVID-19 questionnaire administered by a participating healthcare institution.
Eligibility Criteria
Participants with MS or CIS who are enrolled in MS PATHS under Study 888MS001 and have completed at least one COVID-19 questionnaire administered by a participating healthcare institution will be included in this study.
You may qualify if:
- Be enrolled in MS PATHS under Study 888MS001.
- Completed one or more COVID-19 questionnaire at a participating MS PATHS institution.
- Permission for data linkage either obtained when completing a local COVID-19 questionnaire or granted by waiver of informed consent from the local institutional review board (IRB) or ethics committee (EC).
You may not qualify if:
- \. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the participant unsuitable for participation in the sub-study. A participant only needs to complete the assessments deemed necessary by the Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (6)
Research Site
Baltimore, Maryland, 21287, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
Las Vegas, Nevada, 89106, United States
Research Site
New York, New York, 10016, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Columbus, Ohio, 44195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2021
First Posted
September 28, 2021
Study Start
December 7, 2020
Primary Completion
October 8, 2021
Study Completion
October 8, 2021
Last Updated
April 18, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/