Multiple SclerosisNCT04735406
The MS-LINK™ Outcomes Study
An observational study of Multiple Sclerosis, run by EMD Serono Research & Development Institute, Inc. at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 2,182 participants
- Where
- 9 sitesUnited States
- Study dates
- 24 Mar 2021to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants from United states and Canada with Multiple sclerosis (MS) will be included in this study.
Who may be able to join
- 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
Who cannot join
- Unable to complete questionnaires in English
- Unable to consistently access the Internet
- Participants participating in interventional clinical drug trials at baseline
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Atlanta Neuroscience Institute
Atlanta, Georgia, 30327
The University of Texas of Austin
Austin, Texas, 78759
Alabama Neurology Associates
Birmingham, Alabama, 35209
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
The Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
University of Nebraska medical Center
Omaha, Nebraska, 68198-7835
Memorial healthcare
Owosso, Michigan, 48867
University of Texas Health
San Antonio, Texas, 78229
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
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
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.
- Conditions
- Multiple Sclerosis
- Keywords
- Expanded Disability Status Scale, Multiple Sclerosis, Patient Reported Outcomes Measurement Information System
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Patient-determined Disease Steps (PDDS) Scale Score
Measured: Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Fatigue Score
Measured: Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Physical Function Score
Measured: Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score
Measured: Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) MS Cognitive Function Score
Measured: Baseline up to 3 years
Patient Health Questionnaire 9-Item (PHQ9) Score
Measured: Baseline up to 3 years
Wasson Health Confidence Scale Score
Measured: 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)
Measured: Baseline up to 3 years
Work Productivity and Activity Impairment Questionnaire-Multiple Sclerosis (WPAI-MS) Score
Measured: Baseline up to 3 years
Number of Participants with Reasons for Discontinued Disease-Modifying Therapies (DMT)
Measured: Baseline up to 3 years
Number of Participants with Current Use of Disease-Modifying Therapies (DMT)
Measured: Baseline up to 3 years
Duration of Disease-Modifying Therapies (DMT) use
Measured: Baseline up to 3 years
Number of Participants With Adherence to Treatment as Assessed by Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)
Measured: Baseline up to 3 years
Occurrence of Relapses
Measured: Baseline up to 3 years
Occurrence of Multiple Sclerosis (MS) Symptoms
Measured: Baseline up to 3 years
Number of Utilization of Healthcare Resources by Participants
Measured: 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.
Measured: 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.
Measured: Baseline up to 3 years
Expanded Disability Status Scale (EDSS) Score
Measured: Baseline up to 3 years
Multiple Sclerosis Functional Composite (MSFC) Score
Measured: Baseline up to 3 years
Timed 25-Foot Walk Test
Measured: Baseline up to 3 years
9-Hole Peg Test (9HPT) Score
Measured: Baseline up to 3 years
Paced Auditory Serial Addition Test (PASAT) Score
Measured: Baseline up to 3 years
Symbol Digit Modalities Test (SDMT)
Measured: Baseline up to 3 years
Processing Speed Test (PST)
Measured: Baseline up to 3 years
Number of Participants with Magnetic resonance imaging (MRI) History
Measured: Baseline up to 3 years
Number of Participants with History of Fall
Measured: Baseline up to 3 years
Number of Participants with Adverse Events of Interest
Measured: Baseline up to 3 years
Number of Participants with Symptoms of Coronavirus (COVID)
Measured: Baseline up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start24 Mar 2021
- Primary completion31 Jan 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,182 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735406
- Sponsor's protocol ID
- MS200077_0021
- Status last verified
- Aug 2024
- First submitted
- 28 Jan 2021
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04735406
- Acronym / sponsor ID
- MS200077_0021
- Conditions
- Multiple Sclerosis
- Keywords
- Expanded Disability Status Scale, Multiple Sclerosis, Patient Reported Outcomes Measurement Information System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,182 participants (actual)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants from United states and Canada with Multiple sclerosis (MS) will be included in this study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to complete questionnaires in English
- Unable to consistently access the Internet
- Participants participating in interventional clinical drug trials at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient-determined Disease Steps (PDDS) Scale Score
Time frame: Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Fatigue Score
Time frame: 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
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score
Time frame: Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) MS Cognitive Function Score
Time frame: Baseline up to 3 years
Patient Health Questionnaire 9-Item (PHQ9) Score
Time frame: Baseline up to 3 years
Wasson Health Confidence Scale Score
Time frame: 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
Work Productivity and Activity Impairment Questionnaire-Multiple Sclerosis (WPAI-MS) Score
Time frame: Baseline up to 3 years
Number of Participants with Reasons for Discontinued Disease-Modifying Therapies (DMT)
Time frame: Baseline up to 3 years
Number of Participants with Current Use of Disease-Modifying Therapies (DMT)
Time frame: Baseline up to 3 years
Duration of Disease-Modifying Therapies (DMT) use
Time frame: 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
Occurrence of Relapses
Time frame: Baseline up to 3 years
Occurrence of Multiple Sclerosis (MS) Symptoms
Time frame: Baseline up to 3 years
Number of Utilization of Healthcare Resources by Participants
Time frame: 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.
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.
Expanded Disability Status Scale (EDSS) Score
Time frame: Baseline up to 3 years
Multiple Sclerosis Functional Composite (MSFC) Score
Time frame: Baseline up to 3 years
Timed 25-Foot Walk Test
Time frame: Baseline up to 3 years
9-Hole Peg Test (9HPT) Score
Time frame: Baseline up to 3 years
Paced Auditory Serial Addition Test (PASAT) Score
Time frame: Baseline up to 3 years
Symbol Digit Modalities Test (SDMT)
Time frame: Baseline up to 3 years
Processing Speed Test (PST)
Time frame: Baseline up to 3 years
Number of Participants with Magnetic resonance imaging (MRI) History
Time frame: Baseline up to 3 years
Number of Participants with History of Fall
Time frame: Baseline up to 3 years
Number of Participants with Adverse Events of Interest
Time frame: Baseline up to 3 years
Number of Participants with Symptoms of Coronavirus (COVID)
Time frame: Baseline up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- US Medical Information website, Medical ResourcesLink provided by the sponsor.
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RecruitingPhase 3
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by EMD Serono Research & Development Institute, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-determined Disease Steps (PDDS) Scale Score (time frame: Baseline up to 3 years). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.