Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Patient-reported outcomes, Employment status, Quality of Life, Cognition, Rebif
Brief summary
The purpose of this study is to determine whether Rebif has an impact on employment status, quality of life and cognition.
Detailed description
With this study the investigator plans to evaluate the impact of Rebif on the Real-Life Outcomes (RLO) of Multiple Sclerosis (MS) patients followed at the Clinic within the last two years, and with a follow-up of up to 18 years. The investigator will evaluate the employment outcomes with a questionnaire designed to document eventual changes in the employment status and other variables in the work conditions of the study participants. Furthermore, to evaluate the quality of life (QoL),eligible patients will be asked to complete the Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument, contains 52 items distributed into 12 scales, and two single items. This MS-specific QoL assessment tool uses the Short Form Health Survey (SF-36) as its generic core measure and includes 18 additional items under the following categories: health distress, sexual function, satisfaction with sexual function (one item), overall quality of life, cognitive function, energy, pain, and social function. A sub-group of patients will be selected to come to the clinic to undergo the cognitive portion of the study, using the well-known and validated battery of tests named Minimal Assessment of Cognitive Function in MS (MACFIMS battery). Socio-demographic data on education level, marital and family life will also be collected. All questionnaires (including the MSQoL-54) will be available by means of an online survey.
Interventions
OTHERMACFIMS
Cognitive evaluation of 50 participants
OTHERMSQoL-54
Quality of life questionnaires
Sponsors
EMD Serono Canada Inc.
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with CIS or definite MS (RRMS or SPMS); * Patients seen at our Clinic within the last 2 years; * Patients untreated, or treated with either low dose or high dose Rebif for at least two years; * Patients between 18 to 60 years old at time of treatment initiation; * EDSS ≤ 5.5 at treatment initiation; * Patients able to read and write in French.
Exclusion criteria
* Patients diagnosed with primary progressive MS; * Patients treated with other DMD, other than Rebif; * Co-existence of other diseases that could influence outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Employment status | baseline | The primary endpoint is the proportion of patients in each group belonging in the employment categories listed below: 1. Never worked 2. Work status unchanged 3. Work status changed: Not due to MS / Due to MS Sub-groups: 1. Full employment with accommodations 2. Part-time employment 3. Complete invalidity 4. Patient retired |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Baseline | The MSQoL-54 scores of the Rebif treated patient group compared to the never treated patient group. |
| Cognitive function | Baseline | The comparison of the score of each patient group using the MACFIMS cognitive function tests. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical variables - Composite measure | baseline | The comparison of the clinical variables such as the Kurtzke Expanded Disability Status Scale (EDSS), relapse-rate, MS course and, when available, magnetic resonance imaging (MRI) of each patient group. |
Countries
Canada
Outcome results
None listed