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NCT05058729 Clinical Trial

MS PATHS COVID-19 Questionnaire Data Linkage Sub-Study

Multiple Sclerosis (MS) Clinical Trial

Official title:
Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS) - COVID-19 Questionnaire Linkage Sub-Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05058729
Other study ID # US-MSG-11834
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 7, 2020
Est. completion date October 8, 2021

Study information
Verified date April 2023
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1507
Est. completion date October 8, 2021
Est. primary completion date October 8, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Key Inclusion Criteria: 1. Be enrolled in MS PATHS under Study 888MS001. 2. Completed one or more COVID-19 questionnaire at a participating MS PATHS institution. 3. 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). Key Exclusion Criteria: 1. 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Research Site Baltimore Maryland
United States Research Site Cleveland Ohio
United States Research Site Columbus Ohio
United States Research Site Las Vegas Nevada
United States Research Site New York New York
United States Research Site Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Completed COVID-19 Questionnaires Able to be Linked to a MS PATHS Participant Identifier (ID) Up to 17 months
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