The MS-LINK™ Outcomes Study

The MS-LINK™ Outcomes Study: A Comprehensive Prospective Longitudinal Assessment of Patient and Clinical Reported Outcomes in Multiple Sclerosis Patients Across North America

The Multiple Sclerosis (MS) Leadership and Innovation Network (MS-LINK™) is comprised of networks working cooperatively to advance Multiple Sclerosis (MS) science and improve MS participant outcomes. In this study participants will be followed from the time of consent through the lifetime of the study (currently 3 years), unless the participant chooses to withdraw from the study. Collection of participant's medical history, including MS and treatment history, will be automated through extraction from the participant's electronic medical record (EMR) and other health information systems (for example, radiology). Participants will complete patient-reported outcomes (PROs) and other health-related information digitally. Participating participants will have access to their own data in an ongoing manner via a web-based Participant Portal.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 2182

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Alabama Neurology Associates
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Georgetown University
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • Atlanta NeuroScience Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Owosso, Michigan, United States, 48867
      • Memorial Healthcare
  • Nebraska
    • Omaha, Nebraska, United States, 68198-7835
      • University of Nebraska Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • The Oklahoma Medical Research Foundation
  • Texas
    • Austin, Texas, United States, 78759
      • The University of Texas of Austin
    • San Antonio, Texas, United States, 78229
      • University of Texas Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants from United states and Canada with Multiple sclerosis (MS) will be included in this study.

Description

Inclusion Criteria:

• Participants willing and able to provide written informed consent
• Participants willing to be contacted while participating in the study for recruitment into sub-studies that may be relevant to them
• Participants willing and able to complete PROs on a monthly basis and document events of interest as they occur
• Participants willing to participate in additional follow up at the site for at least three years

Exclusion Criteria:

• Unable to complete questionnaires in English
• Unable to consistently access the Internet
• Participants participating in interventional clinical drug trials at baseline

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Multiple Sclerosis (MS); Data from the participants with diagnosed MS treated and untreated will be part of this study. Medical records of participants will be used to collect demographics and data pertaining to Multiple Sclerosis (MS) management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-determined Disease Steps (PDDS) Scale Score		Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Fatigue Score		Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Physical Function Score		Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score		Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) MS Cognitive Function Score		Baseline up to 3 years
Patient Health Questionnaire 9-Item (PHQ9) Score		Baseline up to 3 years
Wasson Health Confidence Scale Score		Baseline up to 3 years
Health-related Quality of Life Assessed by Centers for Disease Control and Prevention Health-Related Quality of Life Measure (CDC HRQoL-14)		Baseline up to 3 years
Work Productivity and Activity Impairment Questionnaire-Multiple Sclerosis (WPAI-MS) Score		Baseline up to 3 years
Number of Participants with Reasons for Discontinued Disease-Modifying Therapies (DMT)		Baseline up to 3 years
Number of Participants with Current Use of Disease-Modifying Therapies (DMT)		Baseline up to 3 years
Duration of Disease-Modifying Therapies (DMT) use		Baseline up to 3 years
Number of Participants With Adherence to Treatment as Assessed by Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)		Baseline up to 3 years
Occurrence of Relapses		Baseline up to 3 years
Occurrence of Multiple Sclerosis (MS) Symptoms		Baseline up to 3 years
Number of Utilization of Healthcare Resources by Participants		Baseline up to 3 years
Well-being of Participant Assessed by Physical Activity Diary	Participants can opt-in to use the Patient Portal to track their well-being in up to 9 domains like Sleep, Mood, Pain, Exercise, Mobility, Wellness, Energy, Bladder Function, Leisure activities.	Baseline up to 3 years
Number of Participants with Response to Health Priorities and Goals	Responses of participants regarding concern of Multiple Sclerosis (MS) for next visit, priority and wellness goals, and how close they are completing the goal will be recorded.	Baseline up to 3 years
Expanded Disability Status Scale (EDSS) Score		Baseline up to 3 years
Multiple Sclerosis Functional Composite (MSFC) Score		Baseline up to 3 years
Timed 25-Foot Walk Test		Baseline up to 3 years
9-Hole Peg Test (9HPT) Score		Baseline up to 3 years
Paced Auditory Serial Addition Test (PASAT) Score		Baseline up to 3 years
Symbol Digit Modalities Test (SDMT)		Baseline up to 3 years
Processing Speed Test (PST)		Baseline up to 3 years
Number of Participants with Magnetic resonance imaging (MRI) History		Baseline up to 3 years
Number of Participants with History of Fall		Baseline up to 3 years
Number of Participants with Adverse Events of Interest		Baseline up to 3 years
Number of Participants with Symptoms of Coronavirus (COVID)		Baseline up to 3 years

Collaborators and Investigators

• Sponsor: EMD Serono Research & Development Institute, Inc.
• Investigators: Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

Helpful Links

• Trial Awareness and Transparency website

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Expanded Disability Status Scale; Patient Reported Outcomes Measurement Information System
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: MS200077_0021