CHUM
Montreal, Quebec, H2L 4M1, Canada
NCT Number: NCT02377323
The purpose of this study is to determine whether Rebif has an impact on employment status, quality of life and cognition.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H2L 4M1, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cognitive evaluation of 50 participants
Quality of life questionnaires
Time frame: baseline
The primary endpoint is the proportion of patients in each group belonging in the employment categories listed below:
Sub-groups:
Time frame: Baseline
The MSQoL-54 scores of the Rebif treated patient group compared to the never treated patient group.
Time frame: Baseline
The comparison of the score of each patient group using the MACFIMS cognitive function tests.
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.
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif on Employment Status, Quality of Life and Cognition: a Pilot Study
Acronym: RLO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07743281
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
East Hanover, New Jersey, United States
View Trial DetailsNCT03963375
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
St Louis, Missouri, United States
View Trial DetailsNCT02511028
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Bethesda, Maryland, United States
View Trial DetailsNCT07175792
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Diepenbeek, Belgium
View Trial Details