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

October 24, 2017 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
223

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe)
Time Frame: Up to 3 months
Up to 3 months
Percentage of Participants With DMT Administration Schedule Preferences
Time Frame: Up to 3 months
Up to 3 months
Percentage of Participants With DMT Route of Administration Preferences
Time Frame: Up to 3 months
Up to 3 months
DMT Efficacy Based on Annualized Relapse Rate
Time Frame: Up to 3 months
Up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Participants Education Level
Time Frame: Baseline
Baseline
Participants Employment Status
Time Frame: Baseline
Baseline
Participants RRMS Disease Duration
Time Frame: Baseline
Baseline
Number of Relapses of RRMS in Last 2 Years
Time Frame: Baseline
Baseline
Duration since Last Relapse of RRMS
Time Frame: Baseline
Baseline
Participants Current DMT for RRMS
Time Frame: Baseline
Baseline
Number of Previous DMTs Taken Prior to Switch to Current DMT
Time Frame: Baseline
Baseline
Expanded Disability Status Scale (EDSS) Score
Time Frame: Up to 3 months
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
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
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
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 23, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML29715

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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