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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MACFIMS
MSQoL-54
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Patient-reported outcomes, Employment status, Quality of Life, Cognition, Rebif

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHUM

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Treatment with Rebif

Never treated

Arm Description

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

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

Outcomes

Primary Outcome Measures

Employment status
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 Outcome Measures

Quality of life
The MSQoL-54 scores of the Rebif treated patient group compared to the never treated patient group.
Cognitive function
The comparison of the score of each patient group using the MACFIMS cognitive function tests.

Full Information

First Posted
July 31, 2014
Last Updated
May 23, 2017
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
EMD Serono Canada Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02377323
Brief Title
Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif
Acronym
RLO
Official Title
Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif on Employment Status, Quality of Life and Cognition: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
EMD Serono Canada Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Patient-reported outcomes, Employment status, Quality of Life, Cognition, Rebif

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with Rebif
Arm Type
Other
Arm Description
Patients treated with Rebif only, for at least two years, and for up to 18 years
Arm Title
Never treated
Arm Type
Other
Arm Description
Patients never treated with a disease-modifying drug (DMD)
Intervention Type
Other
Intervention Name(s)
MACFIMS
Intervention Description
Cognitive evaluation of 50 participants
Intervention Type
Other
Intervention Name(s)
MSQoL-54
Intervention Description
Quality of life questionnaires
Primary Outcome Measure Information:
Title
Employment status
Description
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
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Quality of life
Description
The MSQoL-54 scores of the Rebif treated patient group compared to the never treated patient group.
Time Frame
Baseline
Title
Cognitive function
Description
The comparison of the score of each patient group using the MACFIMS cognitive function tests.
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Clinical variables - Composite measure
Description
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.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Duquette, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUM
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

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Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif

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