Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis Quality of life
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
EMD Serono
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has any form of MS (confirmed by McDonald and/or Poser criteria) 2. Patient is 18 years old or more (inclusive, at time of informed consent). 3. Patient has an EDSS score lower than 7.0 (inclusive, at time of informed consent) 4. Patient can be with or without treatment 5. Patient has read, understood, signed and dated informed consent form 6. Patient is able to fill in the questionnaire by him/herself
Exclusion criteria
1. CIS Patient (MS not confirmed by Mc Donald and /or Poser criteria) 2. Patient receives or is planned to receive during the course of this study any investigational drug or experimental procedure 3. Patient suffers from dementia in the opinion of the investigator 4. Patient suffers of major medical or psychiatric illness in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Score | Month 24 |
Countries
Argentina, Australia, Austria, France, Germany, Israel, Italy, Norway, Spain, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed