NCT02598167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

December 7, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2016

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

November 4, 2015

Last Update Submit

October 24, 2017

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (4)

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

    Up to 3 months

  • Percentage of Participants With DMT Administration Schedule Preferences

    Up to 3 months

  • Percentage of Participants With DMT Route of Administration Preferences

    Up to 3 months

  • DMT Efficacy Based on Annualized Relapse Rate

    Up to 3 months

Secondary Outcomes (11)

  • Participants Education Level

    Baseline

  • Participants Employment Status

    Baseline

  • Participants RRMS Disease Duration

    Baseline

  • Number of Relapses of RRMS in Last 2 Years

    Baseline

  • Duration since Last Relapse of RRMS

    Baseline

  • +6 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with a diagnosis of RRMS and being prescribed with a DMT for a period of at least 3 months

You may qualify if:

  • 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

You may not qualify if:

  • \- Participants with any personal or medical condition that in opinion of the investigator would interfere with or make impossible proper participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Hospital Sant Joan Despi Moises Broggi; Servicio de Neurología

Sant Joan Despí, Barcelona, 08970, Spain

Location

Hospital Universitario Marques de Valdecilla; Servicio de Neurología

Santander, Cantabria, Spain

Location

Hospital General de Castellon; Servicio de Neurología

Castellon, Castellon, 12004, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología

Lleida, Lerida, 25198, Spain

Location

Hospital Universitario del Sureste; Servicio de Neurologia

Arganda, Madrid, 28500, Spain

Location

Hospital Universitario Rey Juan Carlos de Móstoles; Servicio de Neurología

Móstoles, Madrid, 28933, Spain

Location

Hospital Quiron de Madrid; Servicio de Neurologia

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia

Vigo, Pontevedra, 36312, Spain

Location

Hospital Universitario de Canarias; Servicio de Neurologia

San Cristóbal de La Laguna, Tenerife, Spain

Location

Hospital del Mar; Servicio de Neurologia

Barcelona, 08003, Spain

Location

Hospital Universitario Reina Sofia; Servicio de Neurologia

Córdoba, 14011, Spain

Location

Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia

Girona, 17007, Spain

Location

Hospital General Universitario Gregorio Marañon; Servicio de Neurologia

Madrid, 28007, Spain

Location

Fundacion Jimenez Diaz; Servicio de Neurología

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Neurologia

Madrid, 28041, Spain

Location

Hospital Clinico Universitario de Valencia; Servicio de Neurologia

Valencia, 46010, Spain

Location

Hospital Universitario Dr. Peset; Servicio de Neurologia

Valencia, 46017, Spain

Location

Hospital Universitario La Fe; Unidad de Esclerosis Multiple

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 5, 2015

Study Start

December 7, 2015

Primary Completion

February 23, 2016

Study Completion

February 23, 2016

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations

ES(18)