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NCT04907305 Clinical Trial

Next-Gen MS: Feed-forward PRO Data for MS Research

Multiple Sclerosis (MS) Clinical Trial

Official title:
Next-Gen MS: A Prospective, Cluster-randomized Study Evaluating the Impact of "Feed-forward" Patient Reported Outcomes Data to Clinical Teams Managing Adults Living With MS in a Learning Health System for MS Research

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04907305
Other study ID # MS200077_0013
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2, 2021
Est. completion date April 30, 2026

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
Health authority
Study type Observational

Clinical Trial Summary

This Next Generation learning health system for Multiple Sclerosis (Next-Gen MS) study is a sub-study of the MS-LINK™ Outcomes Study (NCT04735406). The study aims to examine the effects of using feed forward Patient Reported Outcomes (PROs) data in real-world Multiple Sclerosis (MS) care settings. The study will be conducted within an emerging Learning Healthcare System (LHS).

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date April 30, 2026
Est. primary completion date April 30, 2026
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 with clinical diagnosis of Multiple Sclerosis (MS) Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

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 Oklahoma Medical Research Foundation Oklahoma City Oklahoma
United States The Memorial Hospital, d.b.a Memorial Healthcare Owosso Michigan
United States The University of Texas Health Science Center 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 Change From Baseline in Health-Related Quality of Life 14 Item (HR-QoL-14) Baseline up to 18 Months
Secondary Percentage of Participants with >=1-point Increase from Baseline in Patient Determined Disease Steps (PDDS) Sustained Via Consecutive Measures Over 3 Months Baseline up to 18 Months
See also
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