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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting

• Study Type: Observational
• Enrollment (Actual): 223

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar; Servicio de Neurologia
  • Cordoba, Spain, 14011
    • Hospital Universitario Reina Sofia; Servicio de Neurologia
  • Girona, Spain, 17007
    • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre; Servicio de Neurologia
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz; Servicio de Neurología
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
  • Valencia, Spain, 46017
    • Hospital Universitario Dr. Peset; Servicio de Neurologia
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia; Servicio de Neurologia
  • Valencia, Spain, 46026
    • Hospital Universitario La Fe; Unidad de Esclerosis Multiple
  • Barcelona
    • Sant Joan Despí, Barcelona, Spain, 08970
      • Hospital Sant Joan Despi Moises Broggi; Servicio de Neurología
  • Cantabria
    • Santander, Cantabria, Spain
      • Hospital Universitario Marques de Valdecilla; Servicio de Neurología
  • Castellon
    • Castelló de la Plana, Castellon, Spain, 12004
      • Hospital General de Castellon; Servicio de Neurología
  • Lerida
    • Lleida, Lerida, Spain, 25198
      • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
  • Madrid
    • Arganda del Rey, Madrid, Spain, 28500
      • Hospital Universitario del Sureste; Servicio de Neurologia
    • Móstoles, Madrid, Spain, 28933
      • Hospital Universitario Rey Juan Carlos de Móstoles; Servicio de Neurología
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Quiron de Madrid; Servicio de Neurologia
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia
  • Tenerife
    • San Cristóbal de La Laguna, Tenerife, Spain
      • Hospital Universitario de Canarias; Servicio de Neurologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with a diagnosis of RRMS and being prescribed with a DMT for a period of at least 3 months

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
RRMS Population; Participants with a diagnosis of RRMS and being prescribed with a DMT for a period of at least 3 months according to standard local clinical practice will be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Participants Education Level	Baseline
Participants Employment Status	Baseline
Participants RRMS Disease Duration	Baseline
Number of Relapses of RRMS in Last 2 Years	Baseline
Duration since Last Relapse of RRMS	Baseline
Participants Current DMT for RRMS	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
Cognitive performance as measured by the Medical Outcomes Study Cognitive Functioning Scale (MOS Cog-R) Score	Up to 3 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2015
• Primary Completion (Actual): February 23, 2016
• Study Completion (Actual): February 23, 2016

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 4, 2015
• First Posted (Estimate): November 5, 2015

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: ML29715