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Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif

Information source: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: MACFIMS (Other); MSQoL-54 (Other)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Centre hospitalier de l'Université de Montréal (CHUM)

Official(s) and/or principal investigator(s):
Pierre Duquette, MD, Principal Investigator, Affiliation: Centre Hospitalier de l'Université de Montréal

Summary

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Employment status

Secondary outcome:

Quality of life

Cognitive function

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

CHUM, Montréal, Quebec H2L 4M1, Canada
Additional Information

Related publications:

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Starting date: January 2014
Last updated: June 26, 2015

Page last updated: August 20, 2015

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