The MS-LINK™ Outcomes Study

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04735406
• Other study ID #: MS200077_0021
• Status: Recruiting
• Start date: March 24, 2021
• Est. completion date: May 23, 2024

Study information

• Verified date: March 2024
• Source: EMD Serono
• Contact: US Medical Information
• Phone: 888-275-7376
• Email: eMediUSA[@]emdserono.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: May 23, 2024
• Est. primary completion date: May 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Atlanta Neuroscience Institute	Atlanta	Georgia
United States	The University of Texas of Austin	Austin	Texas
United States	Alabama Neurology Associates	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	The Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	University of Nebraska medical Center	Omaha	Nebraska
United States	Memorial healthcare	Owosso	Michigan
United States	University of Texas Health	San Antonio	Texas
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono Research & Development Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-determined Disease Steps (PDDS) Scale Score		Baseline up to 3 years
Primary	Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Fatigue Score		Baseline up to 3 years
Primary	Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Physical Function Score		Baseline up to 3 years
Primary	Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score		Baseline up to 3 years
Primary	Patient Reported Outcomes Measurement Information System (PROMIS) MS Cognitive Function Score		Baseline up to 3 years
Primary	Patient Health Questionnaire 9-Item (PHQ9) Score		Baseline up to 3 years
Primary	Wasson Health Confidence Scale Score		Baseline up to 3 years
Primary	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
Primary	Work Productivity and Activity Impairment Questionnaire-Multiple Sclerosis (WPAI-MS) Score		Baseline up to 3 years
Primary	Number of Participants with Reasons for Discontinued Disease-Modifying Therapies (DMT)		Baseline up to 3 years
Primary	Number of Participants with Current Use of Disease-Modifying Therapies (DMT)		Baseline up to 3 years
Primary	Duration of Disease-Modifying Therapies (DMT) use		Baseline up to 3 years
Primary	Number of Participants With Adherence to Treatment as Assessed by Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)		Baseline up to 3 years
Primary	Occurrence of Relapses		Baseline up to 3 years
Primary	Occurrence of Multiple Sclerosis (MS) Symptoms		Baseline up to 3 years
Primary	Number of Utilization of Healthcare Resources by Participants		Baseline up to 3 years
Primary	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
Primary	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
Primary	Expanded Disability Status Scale (EDSS) Score		Baseline up to 3 years
Primary	Multiple Sclerosis Functional Composite (MSFC) Score		Baseline up to 3 years
Primary	Timed 25-Foot Walk Test		Baseline up to 3 years
Primary	9-Hole Peg Test (9HPT) Score		Baseline up to 3 years
Primary	Paced Auditory Serial Addition Test (PASAT) Score		Baseline up to 3 years
Primary	Symbol Digit Modalities Test (SDMT)		Baseline up to 3 years
Primary	Processing Speed Test (PST)		Baseline up to 3 years
Primary	Number of Participants with Magnetic resonance imaging (MRI) History		Baseline up to 3 years
Primary	Number of Participants with History of Fall		Baseline up to 3 years
Primary	Number of Participants with Adverse Events of Interest		Baseline up to 3 years
Primary	Number of Participants with Symptoms of Coronavirus (COVID)		Baseline up to 3 years

External Links

•   Trial Awareness and Transparency website