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OpenTrials
Completed

NCT Number: NCT02598167

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

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Sant Joan Despi Moises Broggi; Servicio de Neurología, Sant Joan Despí, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe)

    Time frame: Up to 3 months

  2. Percentage of Participants With DMT Administration Schedule Preferences

    Time frame: Up to 3 months

  3. Percentage of Participants With DMT Route of Administration Preferences

    Time frame: Up to 3 months

  4. DMT Efficacy Based on Annualized Relapse Rate

    Time frame: Up to 3 months

Secondary outcomes

  1. Participants Education Level

    Time frame: Baseline

  2. Participants Employment Status

    Time frame: Baseline

  3. Participants RRMS Disease Duration

    Time frame: Baseline

  4. Number of Relapses of RRMS in Last 2 Years

    Time frame: Baseline

  5. Duration since Last Relapse of RRMS

    Time frame: Baseline

  6. Participants Current DMT for RRMS

    Time frame: Baseline

  7. Number of Previous DMTs Taken Prior to Switch to Current DMT

    Time frame: Baseline

  8. Expanded Disability Status Scale (EDSS) Score

    Time frame: Up to 3 months

  9. Health-Related Quality of Life Assessment Using Euro-Quality of Life 5 Dimension Questionnaire (EQ-5D) Scale Score

    Time frame: Up to 3 months

  10. 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

  11. Cognitive performance as measured by the Medical Outcomes Study Cognitive Functioning Scale (MOS Cog-R) Score

    Time frame: Up to 3 months

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Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 5, 2015
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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