A Multi-center, Multi-regional Observational Study to Test the Responsiveness of the Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument to EDSS Status Changes in Any Form of Multiple Sclerosis (MS) in Patients With or Without Treatment (MusiQoL)

June 16, 2014 updated by: EMD Serono

This is a multi-center, multi-regional observational,24 month study.

Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.

Study Overview

Status

Completed

Conditions

Multiple Sclerosis

Detailed Description

This is a multi-center, multi-regional observational,24 month study.

Study Type

Observational

Enrollment (Actual)

599

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

Argentina
- - Buenos Aires, Argentina
    - Research Site
  - Buenos Aires, Argentina
    - Reseach Site
Australia
- - Camperdown, Australia
    - Research Site
  - Melbourne, Australia
    - Research Site
  - New Lambton Heights, Australia
    - Research Site
  - Victoria, Australia
    - Research Site
Austria
- - Graz, Austria
    - Research Site
  - Linz, Austria
    - Research Site
  - Wien, Austria
    - Research Site
France
- - Lomme, France
    - Research Site
  - Marseille, France
    - Research Site
Germany
- - Bad Wildbad, Germany
    - Research Site
  - Bochum, Germany
    - Research Site
  - München, Germany
    - Research Site
Israel
- - Afula, Israel
    - Research Site
  - Ashkelon, Israel
    - Research Site
  - Haifa, Israel
    - Research Site
  - Holon, Israel
    - Research Site
Italy
- - Brindisi, Italy
    - Research Site
  - Centro Bologna, Italy
    - Research Site
  - Firenze, Italy
    - Research Site
  - Modena, Italy
    - Research Site
  - Palermo, Italy
    - Research Site
Norway
- - Lorenskog, Norway
    - Research Site
Spain
- - Malaga, Spain
    - Reseach Site
Turkey
- - Izmir, Turkey
    - Research Site
United Kingdom
- - Glasgow, United Kingdom
    - Research Site
  - Nottingham, United Kingdom
    - Research Site
United States
- Arizona
  - Phoenix, Arizona, United States
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States
    - Research Site

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic

Description

Inclusion Criteria:

Patient has any form of MS (confirmed by McDonald and/or Poser criteria)
Patient is 18 years old or more (inclusive, at time of informed consent).
Patient has an EDSS score lower than 7.0 (inclusive, at time of informed consent)
Patient can be with or without treatment
Patient has read, understood, signed and dated informed consent form
Patient is able to fill in the questionnaire by him/herself

Exclusion Criteria:

CIS Patient (MS not confirmed by Mc Donald and /or Poser criteria)
Patient receives or is planned to receive during the course of this study any investigational drug or experimental procedure
Patient suffers from dementia in the opinion of the investigator
Patient suffers of major medical or psychiatric illness in the opinion of the investigator

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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1
2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Score Time Frame: Month 24	Month 24

Collaborators and Investigators

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

Sponsor

EMD Serono

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life(MusiQoL) questionnaire to changes in disability in subjects with multiple sclerosis: 12-month results. Eur J Neurol 2010;17(Suppl 3):486
Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life and Short Form-36 questionnaires to Expanded Disability Status Scale score changes in subjects with multiple sclerosis: 12-month results of an international observational study. 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS): 13-16 October 2010, Gothenburg, Sweden; P650
Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life questionnaire to Expanded Disability Status Scale score changes in subjects with Multiple Sclerosis: Month 12 results from an international observational study. 13th Annual ISPOR Annual European Congress: November 2010, Prague, Czech Republic; P25667
Baumstarck K, Pelletier J, Boucekine M, Auquier P; MusiQoL study group. Predictors of quality of life in patients with relapsing-remitting multiple sclerosis: a 2-year longitudinal study. Rev Neurol (Paris). 2015 Feb;171(2):173-80. doi: 10.1016/j.neurol.2014.09.005. Epub 2015 Jan 2.
Boucekine M, Loundou A, Baumstarck K, Minaya-Flores P, Pelletier J, Ghattas B, Auquier P. Using the random forest method to detect a response shift in the quality of life of multiple sclerosis patients: a cohort study. BMC Med Res Methodol. 2013 Feb 15;13:20. doi: 10.1186/1471-2288-13-20.

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

November 1, 2007

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria