Clinical trial NCT02377323: Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif
Official title: Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif on Employment Status, Quality of Life and Cognition: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Patient-reported outcomes
Employment status
Quality of Life
Cognition
Rebif
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: EMD Serono Canada Inc.
First posted: 2015-03-03
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Employment status
timeFrame: baseline
Secondary outcomes:
measure: Quality of life
timeFrame: Baseline
measure: Cognitive function
timeFrame: Baseline
Other outcomes:
measure: Clinical variables - Composite measure
timeFrame: baseline
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Pierre Duquette, MD
role: PRINCIPAL_INVESTIGATOR
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