Clinical trial NCT02598167: Participants Preferences to Disease Modifying Agents in Relapsing Remitting Multiple Sclerosis Condition
Official title: Assessing Patients Preferences Towards Disease-modifying Therapeutic Options in Relapsing Remitting Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-05
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe)
timeFrame: Up to 3 months
measure: Percentage of Participants With DMT Administration Schedule Preferences
timeFrame: Up to 3 months
measure: Percentage of Participants With DMT Route of Administration Preferences
timeFrame: Up to 3 months
measure: DMT Efficacy Based on Annualized Relapse Rate
timeFrame: Up to 3 months
Secondary outcomes:
measure: Participants Education Level
timeFrame: Baseline
measure: Participants Employment Status
timeFrame: Baseline
measure: Participants RRMS Disease Duration
timeFrame: Baseline
measure: Number of Relapses of RRMS in Last 2 Years
timeFrame: Baseline
measure: Duration since Last Relapse of RRMS
timeFrame: Baseline
measure: Participants Current DMT for RRMS
timeFrame: Baseline
measure: Number of Previous DMTs Taken Prior to Switch to Current DMT
timeFrame: Baseline
measure: Expanded Disability Status Scale (EDSS) Score
timeFrame: Up to 3 months
measure: Health-Related Quality of Life Assessment Using Euro-Quality of Life 5 Dimension Questionnaire (EQ-5D) Scale Score
timeFrame: Up to 3 months
measure: Participant's Role in Decision Making measured by the Shared Decision Making Questionnaire 9-item version (SDM-Q-9) Score
timeFrame: Up to 3 months
measure: Cognitive performance as measured by the Medical Outcomes Study Cognitive Functioning Scale (MOS Cog-R) Score
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Sant Joan Despí
country: Spain
facility: Hospital Sant Joan Despi Moises Broggi; Servicio de Neurología
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla; Servicio de Neurología
state: Cantabria
city: Castelló de la Plana
country: Spain
facility: Hospital General de Castellon; Servicio de Neurología
state: Castellon
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
state: Lerida
city: Arganda del Rey
country: Spain
facility: Hospital Universitario del Sureste; Servicio de Neurologia
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario Rey Juan Carlos de Móstoles; Servicio de Neurología
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron de Madrid; Servicio de Neurologia
state: Madrid
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia
state: Pontevedra
city: San Cristóbal de La Laguna
country: Spain
facility: Hospital Universitario de Canarias; Servicio de Neurologia
state: Tenerife
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Neurologia
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Neurologia
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz; Servicio de Neurología
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia; Servicio de Neurologia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset; Servicio de Neurologia
city: Valencia
country: Spain
facility: Hospital Universitario La Fe; Unidad de Esclerosis Multiple
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: