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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)

Tracking Information
First Submitted Date  ICMJE July 31, 2014
First Posted Date  ICMJE March 3, 2015
Last Update Posted Date May 24, 2017
Actual Study Start Date  ICMJE January 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
  • Quality of life [ Time Frame: Baseline ]
    The MSQoL-54 scores of the Rebif treated patient group compared to the never treated patient group.
  • Cognitive function [ Time Frame: Baseline ]
    The comparison of the score of each patient group using the MACFIMS cognitive function tests.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 2, 2015)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif
Official Title  ICMJE Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif on Employment Status, Quality of Life and Cognition: a Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Other: MACFIMS
    Cognitive evaluation of 50 participants
  • Other: MSQoL-54
    Quality of life questionnaires
Study Arms  ICMJE
  • Treatment with Rebif
    Patients treated with Rebif only, for at least two years, and for up to 18 years
    Interventions:
    • Other: MACFIMS
    • Other: MSQoL-54
  • Never treated
    Patients never treated with a disease-modifying drug (DMD)
    Interventions:
    • Other: MACFIMS
    • Other: MSQoL-54
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2017)
296
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2015)
600
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02377323
Other Study ID Numbers  ICMJE NE156
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pierre Duquette, Centre hospitalier de l'Université de Montréal (CHUM)
Study Sponsor  ICMJE Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators  ICMJE EMD Serono Canada Inc.
Investigators  ICMJE
Principal Investigator: Pierre Duquette, MD Centre hospitalier de l'Université de Montréal (CHUM)
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP