MS PATHS COVID-19 Questionnaire Data Linkage Sub-Study

Completed

• Conditions: Multiple Sclerosis (MS)

• Registration Number: NCT05058729
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-07
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-09-28
• Primary Completion: 2021-10-08
• Study Completion: 2021-10-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1507

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Completed COVID-19 Questionnaires Able to be Linked to a MS PATHS Participant Identifier (ID)	Up to 17 months

Trial Locations

Locations (1)

Research Site; 🇺🇸 Columbus, Ohio, United States