Assessing Patients Preferences Towards Disease-modifying Therapeutic Options in Relapsing Remitting Multiple Sclerosis

Hoffmann-La Roche18 sites in 1 country223 target enrollmentDecember 7, 2015

ConditionsMultiple Sclerosis, Relapsing-Remitting

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Sclerosis, Relapsing-Remitting
Sponsor: Hoffmann-La Roche
Enrollment: 223
Locations: 18
Primary Endpoint: Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This multi-center non-interventional, observational, cross-sectional study in adult participants with relapsing remitting multiple sclerosis (RRMS) will evaluate the participants' preferences for disease modifying treatments (DMT) in routine clinical practice.

Registry

clinicaltrials.gov

Start Date

December 7, 2015

End Date

February 23, 2016

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants aged greater than or equal to (\>/=) 18 years
•Participants who have a diagnosis of RRMS as documented in their medical records
•Participants who have been prescribed a DMT for at least 3 months
•Participants who have an expanded disability status scale (EDSS) score of 1-6 points

Exclusion Criteria

•Participants with any personal or medical condition that in opinion of the investigator would interfere with or make impossible proper participation in the study

Outcomes

Primary Outcomes

Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe)

Time Frame: Up to 3 months

Percentage of Participants With DMT Administration Schedule Preferences

Time Frame: Up to 3 months

Percentage of Participants With DMT Route of Administration Preferences

Time Frame: Up to 3 months

DMT Efficacy Based on Annualized Relapse Rate

Time Frame: Up to 3 months

Secondary Outcomes

Duration since Last Relapse of RRMS(Baseline)
Participants Current DMT for RRMS(Baseline)
Participants Education Level(Baseline)
Number of Relapses of RRMS in Last 2 Years(Baseline)
Participants Employment Status(Baseline)
Number of Previous DMTs Taken Prior to Switch to Current DMT(Baseline)
Expanded Disability Status Scale (EDSS) Score(Up to 3 months)
Health-Related Quality of Life Assessment Using Euro-Quality of Life 5 Dimension Questionnaire (EQ-5D) Scale Score(Up to 3 months)
Participant's Role in Decision Making measured by the Shared Decision Making Questionnaire 9-item version (SDM-Q-9) Score(Up to 3 months)
Participants RRMS Disease Duration(Baseline)
Cognitive performance as measured by the Medical Outcomes Study Cognitive Functioning Scale (MOS Cog-R) Score(Up to 3 months)