Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: MACFIMS; Other: MSQoL-54

• Registration Number: NCT02377323
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Primary Completion: 2015-05
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with Rebif	MACFIMS	Patients treated with Rebif only, for at least two years, and for up to 18 years
Never treated	MSQoL-54	Patients never treated with a disease-modifying drug (DMD)
Never treated	MACFIMS	Patients never treated with a disease-modifying drug (DMD)
Treatment with Rebif	MSQoL-54	Patients treated with Rebif only, for at least two years, and for up to 18 years

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CHUM; 🇨🇦 Montréal, Quebec, Canada