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MS PATHS COVID-19 Questionnaire Data Linkage Sub-Study

Sponsor
Biogen (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05058729
Collaborator
(none)
10,000
Enrollment
6
Locations
53.2
Anticipated Duration (Months)
1666.7
Patients Per Site
31.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS) - COVID-19 Questionnaire Linkage Sub-Study
    Actual Study Start Date :
    Dec 7, 2020
    Anticipated Primary Completion Date :
    May 13, 2025
    Anticipated Study Completion Date :
    May 13, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Completed COVID-19 Questionnaires Able to be Linked to a MS PATHS Participant Identifier (ID) [Up to 17 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Baltimore Maryland United States 21287
    2 Research Site Saint Louis Missouri United States 63110
    3 Research Site Las Vegas Nevada United States 89106
    4 Research Site New York New York United States 10016
    5 Research Site Cleveland Ohio United States 44195
    6 Research Site Columbus Ohio United States 44195

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT05058729
    Other Study ID Numbers:
    • US-MSG-11834
    First Posted:
    Sep 28, 2021
    Last Update Posted:
    Jul 1, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Jul 1, 2022