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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Hoffmann-La Roche

Dates:
Date Received: November 4, 2015
Date Started: December 2015
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016