MS PATHS COVID-19 Questionnaire Data Linkage Sub-Study

NCT ID: NCT05058729

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1507 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-07

Study Completion Date

2021-10-08

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis (MS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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).

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

Baltimore, Maryland, United States

Site Status

Research Site

St Louis, Missouri, United States

Site Status

Research Site

Las Vegas, Nevada, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Cleveland, Ohio, United States

Site Status

Research Site

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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US-MSG-11834

Identifier Type: -

Identifier Source: org_study_id

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