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CompletedNCT02598167Updated Oct 25, 2017

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

An observational study in Multiple Sclerosis, Relapsing-Remitting, sponsored by Hoffmann-La Roche. Completed at 18 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-25.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
223
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Multiple Sclerosis, Relapsing-Remitting
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 223 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
223 participants (actual)

Groups and cohorts

  • 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.

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What researchers measure

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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Study locations

18 sites
  • Hospital Sant Joan Despi Moises Broggi; Servicio de Neurología
    Sant Joan Despí, Barcelona 08970, Spain
  • Hospital Universitario Marques de Valdecilla; Servicio de Neurología
    Santander, Cantabria, Spain
  • Hospital General de Castellon; Servicio de Neurología
    Castelló de la Plana, Castellon 12004, Spain
  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
    Lleida, Lerida 25198, Spain
  • Hospital Universitario del Sureste; Servicio de Neurologia
    Arganda del Rey, Madrid 28500, Spain
  • Hospital Universitario Rey Juan Carlos de Móstoles; Servicio de Neurología
    Móstoles, Madrid 28933, Spain
  • Hospital Quiron de Madrid; Servicio de Neurologia
    Pozuelo de Alarcon, Madrid 28223, Spain
  • Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia
    Vigo, Pontevedra 36312, Spain
  • Hospital Universitario de Canarias; Servicio de Neurologia
    San Cristóbal de La Laguna, Tenerife, Spain
  • Hospital del Mar; Servicio de Neurologia
    Barcelona, 08003, Spain
  • Hospital Universitario Reina Sofia; Servicio de Neurologia
    Cordoba, 14011, Spain
  • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
    Girona, 17007, Spain
  • Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
    Madrid, 28007, Spain
  • Fundacion Jimenez Diaz; Servicio de Neurología
    Madrid, 28040, Spain
  • Hospital Universitario 12 de Octubre; Servicio de Neurologia
    Madrid, 28041, Spain
  • Hospital Clinico Universitario de Valencia; Servicio de Neurologia
    Valencia, 46010, Spain
  • Hospital Universitario Dr. Peset; Servicio de Neurologia
    Valencia, 46017, Spain
  • Hospital Universitario La Fe; Unidad de Esclerosis Multiple
    Valencia, 46026, Spain
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02598167
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Nov 5, 2015
Start date
Dec 7, 2015
Primary completion
Feb 23, 2016
Completion
Feb 23, 2016
Last update
Oct 25, 2017

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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