Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif

NCT02377323 | Completed

• 1 other identifier: NE156
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Patient-reported outcomes; Employment status; Quality of Life; Cognition; Rebif

Outcome Measures

Primary Outcomes (1)

• Employment status

  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 Outcomes (2)

• Quality of life

  Baseline

• Cognitive function

  Baseline

Other Outcomes (1)

• Clinical variables - Composite measure

  baseline

Study Arms (2)

Treatment with Rebif

OTHER

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

Other: MACFIMS; Other: MSQoL-54

Never treated

OTHER

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

Other: MACFIMS; Other: MSQoL-54

Interventions

MACFIMS OTHER

Cognitive evaluation of 50 participants

Never treated; Treatment with Rebif

MSQoL-54 OTHER

Quality of life questionnaires

Never treated; Treatment with Rebif

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients diagnosed with primary progressive MS;
• Patients treated with other DMD, other than Rebif;
• Co-existence of other diseases that could influence outcomes.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• EMD Serono Canada Inc.: collaborator

Study Sites (1)

CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (24)

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MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pierre Duquette, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: March 3, 2015
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2016
• Last Updated: May 24, 2017

Record last verified: 2017-05

Locations

CA (1)