Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif (RLO)

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: MACFIMS; Other: MSQoL-54

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02377323

NE156

Details and patient eligibility

About

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

Full 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.

Enrollment: 296 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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296 participants in 2 patient groups

Treatment with Rebif

Other group

Description:

Patients treated with Rebif only, for at least two years, and for up to 18 years

Treatment:

Other: MSQoL-54

Other: MACFIMS

Never treated

Other group

Description:

Patients never treated with a disease-modifying drug (DMD)

Treatment:

Other: MSQoL-54

Other: MACFIMS