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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598167
• Other study ID #: ML29715
• Status: Completed
• Phase: N/A
• First received: November 4, 2015
• Last updated: October 24, 2017
• Start date: December 7, 2015
• Est. completion date: February 23, 2016

Study information

• Verified date: October 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: February 23, 2016
• Est. primary completion date: February 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Locations

Country	Name	City	State
Spain	Hospital Universitario del Sureste; Servicio de Neurologia	Arganda del Rey	Madrid
Spain	Hospital del Mar; Servicio de Neurologia	Barcelona
Spain	Hospital General de Castellon; Servicio de Neurología	Castelló de la Plana	Castellon
Spain	Hospital Universitario Reina Sofia; Servicio de Neurologia	Cordoba
Spain	Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia	Girona
Spain	Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología	Lleida	Lerida
Spain	Fundacion Jimenez Diaz; Servicio de Neurología	Madrid
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Neurologia	Madrid
Spain	Hospital Universitario 12 de Octubre; Servicio de Neurologia	Madrid
Spain	Hospital Universitario Rey Juan Carlos de Móstoles; Servicio de Neurología	Móstoles	Madrid
Spain	Hospital Quiron de Madrid; Servicio de Neurologia	Pozuelo de Alarcon	Madrid
Spain	Hospital Universitario de Canarias; Servicio de Neurologia	San Cristóbal de La Laguna	Tenerife
Spain	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 Clinico Universitario de Valencia; Servicio de Neurologia	Valencia
Spain	Hospital Universitario Dr. Peset; Servicio de Neurologia	Valencia
Spain	Hospital Universitario La Fe; Unidad de Esclerosis Multiple	Valencia
Spain	Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe)		Up to 3 months
Primary	Percentage of Participants With DMT Administration Schedule Preferences		Up to 3 months
Primary	Percentage of Participants With DMT Route of Administration Preferences		Up to 3 months
Primary	DMT Efficacy Based on Annualized Relapse Rate		Up to 3 months
Secondary	Participants Education Level		Baseline
Secondary	Participants Employment Status		Baseline
Secondary	Participants RRMS Disease Duration		Baseline
Secondary	Number of Relapses of RRMS in Last 2 Years		Baseline
Secondary	Duration since Last Relapse of RRMS		Baseline
Secondary	Participants Current DMT for RRMS		Baseline
Secondary	Number of Previous DMTs Taken Prior to Switch to Current DMT		Baseline
Secondary	Expanded Disability Status Scale (EDSS) Score		Up to 3 months
Secondary	Health-Related Quality of Life Assessment Using Euro-Quality of Life 5 Dimension Questionnaire (EQ-5D) Scale Score		Up to 3 months
Secondary	Participant's Role in Decision Making measured by the Shared Decision Making Questionnaire 9-item version (SDM-Q-9) Score		Up to 3 months
Secondary	Cognitive performance as measured by the Medical Outcomes Study Cognitive Functioning Scale (MOS Cog-R) Score		Up to 3 months