Participants Preferences to Disease Modifying Agents in Relapsing Remitting Multiple Sclerosis Condition
- 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
- 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
- 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
Name Time Method Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe) Up to 3 months Percentage of Participants With DMT Administration Schedule Preferences Up to 3 months Percentage of Participants With DMT Route of Administration Preferences Up to 3 months DMT Efficacy Based on Annualized Relapse Rate Up to 3 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (18)
Hospital Sant Joan Despi Moises Broggi; Servicio de Neurología
🇪🇸Sant Joan Despí, Barcelona, Spain
Hospital Clinico Universitario de Valencia; Servicio de Neurologia
🇪🇸Valencia, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Neurología
🇪🇸Santander, Cantabria, Spain
Hospital General de Castellon; Servicio de Neurología
🇪🇸Castelló de la Plana, Castellon, Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
🇪🇸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
🇪🇸Móstoles, Madrid, Spain
Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia
🇪🇸Vigo, Pontevedra, Spain
Hospital del Mar; Servicio de Neurologia
🇪🇸Barcelona, Spain
Hospital Universitario de Canarias; Servicio de Neurologia
🇪🇸San Cristóbal de La Laguna, Tenerife, Spain
Hospital Universitario Reina Sofia; Servicio de Neurologia
🇪🇸Cordoba, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
🇪🇸Madrid, Spain
Fundacion Jimenez Diaz; Servicio de Neurología
🇪🇸Madrid, Spain
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
🇪🇸Girona, Spain
Hospital Universitario 12 de Octubre; Servicio de Neurologia
🇪🇸Madrid, Spain
Hospital Universitario Dr. Peset; Servicio de Neurologia
🇪🇸Valencia, Spain
Hospital Universitario La Fe; Unidad de Esclerosis Multiple
🇪🇸Valencia, Spain
Hospital Quiron de Madrid; Servicio de Neurologia
🇪🇸Pozuelo de Alarcon, Madrid, Spain