MS PATHS COVID-19 Questionnaire Data Linkage Sub-Study

Biogen

Status: Completed

Conditions: Multiple Sclerosis (MS)

Study type: Observational

Funder types: Industry

Identifiers

NCT05058729

US-MSG-11834

Details and patient eligibility

About

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.

Enrollment: 1,507 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

1,507 participants in 1 patient group

Cohort 1

Description:

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.