Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif

Centre hospitalier de l'Université de Montréal (CHUM)296 enrolled

Overview

The purpose of this study is to determine whether Rebif has an impact on employment status, quality of life and cognition.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

296

Conditions

Multiple Sclerosis

Interventions

MACFIMSOTHER

Cognitive evaluation of 50 participants

MSQoL-54OTHER

Quality of life questionnaires

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

CHUM

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Employment status

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

Time frame: baseline

Secondary Outcomes

Quality of life

The MSQoL-54 scores of the Rebif treated patient group compared to the never treated patient group.

Time frame: Baseline

Cognitive function

The comparison of the score of each patient group using the MACFIMS cognitive function tests.

Time frame: Baseline

Data from ClinicalTrials.gov

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