Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377323
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
EMD Serono Canada Inc.
Information provided by (Responsible Party):
Pierre Duquette, 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: MACFIMS Other: MSQoL-54 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 296 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif on Employment Status, Quality of Life and Cognition: a Pilot Study
Actual Study Start Date : January 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377323


Locations
Layout table for location information
Canada, Quebec
CHUM
Montréal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
EMD Serono Canada Inc.
Investigators
Layout table for investigator information
Principal Investigator: Pierre Duquette, MD Centre hospitalier de l'Université de Montréal (CHUM)
Publications:
Beatty WW, Hames KA, Blanco CR, et al. Demographic, clinical and cognitive characteristics of multiple sclerosis patients who continue to work. J Neurol Rehab 1995; 9:167-73.

Layout table for additonal information
Responsible Party: Pierre Duquette, MD, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02377323    
Other Study ID Numbers: NE156
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Keywords provided by Pierre Duquette, Centre hospitalier de l'Université de Montréal (CHUM):
Multiple Sclerosis
Patient-reported outcomes
Employment status
Quality of Life
Cognition
Rebif
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases