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Completed

NCT Number: NCT02377323

Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUM

Montreal, Quebec, H2L 4M1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MACFIMS

Other

Cognitive evaluation of 50 participants

MSQoL-54

Other

Quality of life questionnaires

Primary outcomes

  1. Employment status

    Time frame: baseline

    The primary endpoint is the proportion of patients in each group belonging in the employment categories listed below:

    • Never worked
    • Work status unchanged
    • Work status changed: Not due to MS / Due to MS

    Sub-groups:

    • Full employment with accommodations
    • Part-time employment
    • Complete invalidity
    • Patient retired

Secondary outcomes

  1. Quality of life

    Time frame: Baseline

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

  2. Cognitive function

    Time frame: Baseline

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

Other outcomes

  1. Clinical variables - Composite measure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • EMD Serono Canada Inc.

Registry information

Official study title

Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif on Employment Status, Quality of Life and Cognition: a Pilot Study

Acronym: RLO

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 3, 2015
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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