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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02598167

Enrollment

223

Registered

2015-11-05

Start date

2015-12-07

Completion date

2016-02-23

Last updated

2017-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame
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
Participants Education Level	Baseline
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
Expanded Disability Status Scale (EDSS) Score	Up to 3 months
Participants Employment Status	Baseline
Participants RRMS Disease Duration	Baseline
Number of Relapses of RRMS in Last 2 Years	Baseline

Countries

Spain

Outcome results