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

May 23, 2017 updated by: Pierre Duquette, Centre hospitalier de l'Université de Montréal (CHUM)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

296

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2L 4M1
        • CHUM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment with Rebif
Patients treated with Rebif only, for at least two years, and for up to 18 years
Other: MACFIMS
Cognitive evaluation of 50 participants
Other: MSQoL-54
Quality of life questionnaires
Other: Never treated
Patients never treated with a disease-modifying drug (DMD)
Other: MACFIMS
Cognitive evaluation of 50 participants
Other: MSQoL-54
Quality of life questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Employment status
Time Frame: 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
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Baseline
The MSQoL-54 scores of the Rebif treated patient group compared to the never treated patient group.
Baseline
Cognitive function
Time Frame: Baseline
The comparison of the score of each patient group using the MACFIMS cognitive function tests.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

EMD Serono Canada Inc.

Investigators

  • Principal Investigator: Pierre Duquette, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NE156

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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