Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif
NCT ID: NCT02377323
Last Updated: 2017-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
296 participants
INTERVENTIONAL
2014-01-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Observational Study to Evaluate Quality of Life (QoL) and Influence of Cognitive Status on QoL in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) During 2 Years Treatment With Rebif New Formulation (RNF)
NCT01110993
An Observational Study Comparing Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54) in Relapsing Multiple Sclerosis (RMS) Patients on Long-term Rebif® Therapy
NCT01141751
Rebif New Formulation (RNF) Quality of Life (QOL) Study
NCT00472797
Post-Authorization Observational Study to Evaluate Cognition and Fatigue in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Treated With Rebif®
NCT01075880
A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis
NCT02064816
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment with Rebif
Patients treated with Rebif only, for at least two years, and for up to 18 years
MACFIMS
Cognitive evaluation of 50 participants
MSQoL-54
Quality of life questionnaires
Never treated
Patients never treated with a disease-modifying drug (DMD)
MACFIMS
Cognitive evaluation of 50 participants
MSQoL-54
Quality of life questionnaires
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MACFIMS
Cognitive evaluation of 50 participants
MSQoL-54
Quality of life questionnaires
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 treated with other DMD, other than Rebif;
* Co-existence of other diseases that could influence outcomes.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
EMD Serono Canada Inc.
INDUSTRY
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pierre Duquette
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pierre Duquette, MD
Role: PRINCIPAL_INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHUM
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Roessler RT, Rumrill PD Jr. Multiple sclerosis and employment barriers: a systemic perspective on diagnosis and intervention. Work. 2003;21(1):17-23.
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.
Simmons RD, Tribe KL, McDonald EA. Living with multiple sclerosis: longitudinal changes in employment and the importance of symptom management. J Neurol. 2010 Jun;257(6):926-36. doi: 10.1007/s00415-009-5441-7. Epub 2010 Jan 19.
Larocca N, Kalb R, Scheinberg L, Kendall P. Factors associated with unemployment of patients with multiple sclerosis. J Chronic Dis. 1985;38(2):203-10. doi: 10.1016/0021-9681(85)90093-1.
Smith MM, Arnett PA. Factors related to employment status changes in individuals with multiple sclerosis. Mult Scler. 2005 Oct;11(5):602-9. doi: 10.1191/1352458505ms1204oa.
Verdier-Taillefer MH, Sazdovitch V, Borgel F, Cesaro P, Kurtz A, Millet MF, Roullet E, Marteau R. Occupational environment as risk factor for unemployment in multiple sclerosis. Acta Neurol Scand. 1995 Jul;92(1):59-62. doi: 10.1111/j.1600-0404.1995.tb00467.x.
Glad SB, Nyland H, Aarseth JH, Riise T, Myhr KM. How long can you keep working with benign multiple sclerosis? J Neurol Neurosurg Psychiatry. 2011 Jan;82(1):78-82. doi: 10.1136/jnnp.2010.210732. Epub 2010 Aug 27.
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.
Benito-Leon J, Morales JM, Rivera-Navarro J, Mitchell A. A review about the impact of multiple sclerosis on health-related quality of life. Disabil Rehabil. 2003 Dec 2;25(23):1291-303. doi: 10.1080/09638280310001608591.
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.
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.
Solari A. Role of health-related quality of life measures in the routine care of people with multiple sclerosis. Health Qual Life Outcomes. 2005 Mar 18;3:16. doi: 10.1186/1477-7525-3-16.
Amato MP, Zipoli V, Portaccio E. Multiple sclerosis-related cognitive changes: a review of cross-sectional and longitudinal studies. J Neurol Sci. 2006 Jun 15;245(1-2):41-6. doi: 10.1016/j.jns.2005.08.019. Epub 2006 Apr 27.
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.
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.
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.
Jennekens-Schinkel A, Laboyrie PM, Lanser JB, van der Velde EA. Cognition in patients with multiple sclerosis After four years. J Neurol Sci. 1990 Nov;99(2-3):229-47. doi: 10.1016/0022-510x(90)90158-j.
Amato MP, Ponziani G, Siracusa G, Sorbi S. Cognitive dysfunction in early-onset multiple sclerosis: a reappraisal after 10 years. Arch Neurol. 2001 Oct;58(10):1602-6. doi: 10.1001/archneur.58.10.1602.
Benedict RH, Cookfair D, Gavett R, Gunther M, Munschauer F, Garg N, Weinstock-Guttman B. Validity of the minimal assessment of cognitive function in multiple sclerosis (MACFIMS). J Int Neuropsychol Soc. 2006 Jul;12(4):549-58. doi: 10.1017/s1355617706060723.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NE156
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.