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| Name | Class |
|---|---|
| EMD Serono Canada Inc. | INDUSTRY |
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The purpose of this study is to determine whether Rebif has an impact on employment status, quality of life and cognition.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Rebif | Other | Patients treated with Rebif only, for at least two years, and for up to 18 years |
|
| Never treated | Other | Patients never treated with a disease-modifying drug (DMD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MACFIMS | Other | Cognitive evaluation of 50 participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Employment status | The primary endpoint is the proportion of patients in each group belonging in the employment categories listed below:
Sub-groups:
| baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | The MSQoL-54 scores of the Rebif treated patient group compared to the never treated patient group. | Baseline |
| Cognitive function | The comparison of the score of each patient group using the MACFIMS cognitive function tests. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical variables - Composite measure | 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. | baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Duquette, MD | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUM | Montreal | Quebec | H2L 4M1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19847899 | Background | Trojano M, Pellegrini F, Paolicelli D, Fuiani A, Zimatore GB, Tortorella C, Simone IL, Patti F, Ghezzi A, Zipoli V, Rossi P, Pozzilli C, Salemi G, Lugaresi A, Bergamaschi R, Millefiorini E, Clerico M, Lus G, Vianello M, Avolio C, Cavalla P, Lepore V, Livrea P, Comi G, Amato MP; Italian Multiple Sclerosis Database Network (MSDN) Group. Real-life impact of early interferon beta therapy in relapsing multiple sclerosis. Ann Neurol. 2009 Oct;66(4):513-20. doi: 10.1002/ana.21757. | |
| 23244804 |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| MSQoL-54 | Other | Quality of life questionnaires |
|
| Baseline |
| Background |
| Glanz BI, Degano IR, Rintell DJ, Chitnis T, Weiner HL, Healy BC. Work productivity in relapsing multiple sclerosis: associations with disability, depression, fatigue, anxiety, cognition, and health-related quality of life. Value Health. 2012 Dec;15(8):1029-35. doi: 10.1016/j.jval.2012.07.010. Epub 2012 Oct 25. |
| 20350069 | Background | Krokavcova M, Nagyova I, Van Dijk JP, Rosenberger J, Gavelova M, Middel B, Szilasiova J, Gdovinova Z, Groothoff JW. Self-rated health and employment status in patients with multiple sclerosis. Disabil Rehabil. 2010;32(21):1742-8. doi: 10.3109/09638281003734334. |
| 12897387 | Background | Roessler RT, Rumrill PD Jr. Multiple sclerosis and employment barriers: a systemic perspective on diagnosis and intervention. Work. 2003;21(1):17-23. |
| Background | 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. |
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| 1823781 | Background | Rao SM, Leo GJ, Ellington L, Nauertz T, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. II. Impact on employment and social functioning. Neurology. 1991 May;41(5):692-6. doi: 10.1212/wnl.41.5.692. |
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| 1449401 | Background | Rudick RA, Miller D, Clough JD, Gragg LA, Farmer RG. Quality of life in multiple sclerosis. Comparison with inflammatory bowel disease and rheumatoid arthritis. Arch Neurol. 1992 Dec;49(12):1237-42. doi: 10.1001/archneur.1992.00530360035014. |
| 17310341 | Background | Kobelt G, Berg J, Lindgren P, Kerrigan J, Russell N, Nixon R. Costs and quality of life of multiple sclerosis in the United Kingdom. Eur J Health Econ. 2006 Sep;7 Suppl 2:S96-104. doi: 10.1007/s10198-006-0380-z. |
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| 2027484 | Background | Rao SM, Leo GJ, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns, and prediction. Neurology. 1991 May;41(5):685-91. doi: 10.1212/wnl.41.5.685. |
| 7848126 | Background | Amato MP, Ponziani G, Pracucci G, Bracco L, Siracusa G, Amaducci L. Cognitive impairment in early-onset multiple sclerosis. Pattern, predictors, and impact on everyday life in a 4-year follow-up. Arch Neurol. 1995 Feb;52(2):168-72. doi: 10.1001/archneur.1995.00540260072019. |
| 9117376 | Background | Kujala P, Portin R, Ruutiainen J. The progress of cognitive decline in multiple sclerosis. A controlled 3-year follow-up. Brain. 1997 Feb;120 ( Pt 2):289-97. doi: 10.1093/brain/120.2.289. |
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| 10467384 | Background | Fischer JS, LaRocca NG, Miller DM, Ritvo PG, Andrews H, Paty D. Recent developments in the assessment of quality of life in multiple sclerosis (MS). Mult Scler. 1999 Aug;5(4):251-9. doi: 10.1177/135245859900500410. |
| 7613530 | Background | Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |