Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif

Multiple Sclerosis Clinical Trial

— RLO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377323
• Other study ID #: NE156
• Status: Completed
• Phase: N/A
• First received: July 31, 2014
• Last updated: May 23, 2017
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: December 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• MACFIMS
Cognitive evaluation of 50 participants
• MSQoL-54
Quality of life questionnaires

Locations

Country	Name	City	State
Canada	CHUM	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	EMD Serono Canada Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (24)

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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. — View Citation

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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.

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. — View Citation

Benito-León 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. Review. — View Citation

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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. — View Citation

Roessler RT, Rumrill PD Jr. Multiple sclerosis and employment barriers: a systemic perspective on diagnosis and intervention. Work. 2003;21(1):17-23. — View Citation

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. — View Citation

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. — View Citation

Smith MM, Arnett PA. Factors related to employment status changes in individuals with multiple sclerosis. Mult Scler. 2005 Oct;11(5):602-9. — View Citation

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. Review. — View Citation

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. — View Citation

Verdier-Taillefer MH, Sazdovitch V, Borgel F, Césaro 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. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Employment status	The primary endpoint is the proportion of patients in each group belonging in the employment categories listed below: Never worked; Work status unchanged; Work status changed: Not due to MS / Due to MS; Sub-groups: Full employment with accommodations; Part-time employment; Complete invalidity; Patient retired	baseline
Secondary	Quality of life	The MSQoL-54 scores of the Rebif treated patient group compared to the never treated patient group.	Baseline
Secondary	Cognitive function	The comparison of the score of each patient group using the MACFIMS cognitive function tests.	Baseline