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Participants Preferences to Disease Modifying Agents in Relapsing Remitting Multiple Sclerosis Condition

Completed
Conditions
Multiple Sclerosis, Relapsing-Remitting
Registration Number
NCT02598167
Lead Sponsor
Hoffmann-La Roche
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
223
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe)Up to 3 months
Percentage of Participants With DMT Administration Schedule PreferencesUp to 3 months
Percentage of Participants With DMT Route of Administration PreferencesUp to 3 months
DMT Efficacy Based on Annualized Relapse RateUp to 3 months
Secondary Outcome Measures
NameTimeMethod
Duration since Last Relapse of RRMSBaseline
Participants Current DMT for RRMSBaseline
Participants Education LevelBaseline
Number of Relapses of RRMS in Last 2 YearsBaseline
Participants Employment StatusBaseline
Number of Previous DMTs Taken Prior to Switch to Current DMTBaseline
Expanded Disability Status Scale (EDSS) ScoreUp to 3 months
Health-Related Quality of Life Assessment Using Euro-Quality of Life 5 Dimension Questionnaire (EQ-5D) Scale ScoreUp to 3 months
Participant's Role in Decision Making measured by the Shared Decision Making Questionnaire 9-item version (SDM-Q-9) ScoreUp to 3 months
Participants RRMS Disease DurationBaseline
Cognitive performance as measured by the Medical Outcomes Study Cognitive Functioning Scale (MOS Cog-R) ScoreUp to 3 months

Trial Locations

Locations (18)

Hospital Sant Joan Despi Moises Broggi; Servicio de Neurología

🇪🇸

Sant Joan Despí, Barcelona, Spain

Hospital Universitario Marques de Valdecilla; Servicio de Neurología

🇪🇸

Santander, Cantabria, Spain

Hospital General de Castellon; Servicio de Neurología

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Castelló de la Plana, Castellon, Spain

Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología

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Lleida, Lerida, Spain

Hospital Universitario del Sureste; Servicio de Neurologia

🇪🇸

Arganda del Rey, Madrid, Spain

Hospital Universitario Rey Juan Carlos de Móstoles; Servicio de Neurología

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Móstoles, Madrid, Spain

Hospital Quiron de Madrid; Servicio de Neurologia

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Pozuelo de Alarcon, Madrid, Spain

Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia

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Vigo, Pontevedra, Spain

Hospital Universitario de Canarias; Servicio de Neurologia

🇪🇸

San Cristóbal de La Laguna, Tenerife, Spain

Hospital del Mar; Servicio de Neurologia

🇪🇸

Barcelona, Spain

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Hospital Sant Joan Despi Moises Broggi; Servicio de Neurología
🇪🇸Sant Joan Despí, Barcelona, Spain

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