The MS-LINK™ Outcomes Study

August 21, 2024 updated by: EMD Serono Research & Development Institute, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2182

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient-determined Disease Steps (PDDS) Scale Score
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Fatigue Score
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Physical Function Score
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) MS Cognitive Function Score
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Patient Health Questionnaire 9-Item (PHQ9) Score
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Wasson Health Confidence Scale Score
Time Frame: Baseline up to 3 years
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)
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Work Productivity and Activity Impairment Questionnaire-Multiple Sclerosis (WPAI-MS) Score
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Number of Participants with Reasons for Discontinued Disease-Modifying Therapies (DMT)
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Number of Participants with Current Use of Disease-Modifying Therapies (DMT)
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Duration of Disease-Modifying Therapies (DMT) use
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Number of Participants With Adherence to Treatment as Assessed by Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Occurrence of Relapses
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Occurrence of Multiple Sclerosis (MS) Symptoms
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Number of Utilization of Healthcare Resources by Participants
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Well-being of Participant Assessed by Physical Activity Diary
Time Frame: Baseline up to 3 years
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
Time Frame: Baseline up to 3 years
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
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Multiple Sclerosis Functional Composite (MSFC) Score
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Timed 25-Foot Walk Test
Time Frame: Baseline up to 3 years
Baseline up to 3 years
9-Hole Peg Test (9HPT) Score
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Paced Auditory Serial Addition Test (PASAT) Score
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Symbol Digit Modalities Test (SDMT)
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Processing Speed Test (PST)
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Number of Participants with Magnetic resonance imaging (MRI) History
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Number of Participants with History of Fall
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Number of Participants with Adverse Events of Interest
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Number of Participants with Symptoms of Coronavirus (COVID)
Time Frame: Baseline up to 3 years
Baseline up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EMD Serono Research & Development Institute, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS200077_0021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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