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AzTrials

Multiple SclerosisRLONCT02377323

Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif

A study testing MACFIMS and MSQoL-54 in people with Multiple Sclerosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
MACFIMS and MSQoL-54
Could I receive a placebo?
No, everyone receives an active treatment
How many people
296 participants
Where
1 siteCanada
Study dates
Jan 2014to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Patients diagnosed with primary progressive MS;
  • Patients treated with other DMD, other than Rebif;
  • Co-existence of other diseases that could influence outcomes.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • CHUM

    Montreal, Quebec, H2L 4M1

Other trials in Canada

About this study

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

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

Read the 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.

Being tested
MACFIMS, MSQoL-54
Keywords
Multiple Sclerosis, Patient-reported outcomes, Employment status, Quality of Life, Cognition, Rebif
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MACFIMSOther

    Cognitive evaluation of 50 participants

  • MSQoL-54Other

    Quality of life questionnaires

Study groups in NCT02377323
Study groupRoleWhat they receive
Treatment with RebifOtherPatients treated with Rebif only, for at least two years, and for up to 18 years
Receives: Other: MACFIMS; Other: MSQoL-54
Never treatedOtherPatients never treated with a disease-modifying drug (DMD)
Receives: Other: MACFIMS; Other: MSQoL-54

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Employment status

    The primary endpoint is the proportion of patients in each group belonging in the employment categories listed below:

    1. Never worked
    2. Work status unchanged
    3. Work status changed: Not due to MS / Due to MS

    Sub-groups:

    1. Full employment with accommodations
    2. Part-time employment
    3. Complete invalidity
    4. Patient retired

    Measured: baseline

Secondary outcomes (2)

  1. Quality of life

    The MSQoL-54 scores of the Rebif treated patient group compared to the never treated patient group.

    Measured: Baseline

  2. Cognitive function

    The comparison of the score of each patient group using the MACFIMS cognitive function tests.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionMay 2015
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02377323
Sponsor's protocol ID
NE156
Acronym
RLO
Status last verified
May 2017
First submitted
31 Jul 2014
Last updated
24 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19847899

  • 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.

    PubMed 23244804

  • 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.

    PubMed 20350069

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

    PubMed 12897387

  • 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.

    PubMed 20084515

  • 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.

    PubMed 3156140

  • 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.

    PubMed 16193900

  • 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.

    PubMed 7572062

  • 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.

    PubMed 20802029

  • 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.

    PubMed 1823781

  • 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.

    PubMed 14617435

  • 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.

    PubMed 1449401

  • 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.

    PubMed 17310341

  • 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.

    PubMed 15777478

Questions about this trial

What is this clinical trial studying?

A study testing MACFIMS and MSQoL-54 in people with Multiple Sclerosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Employment status (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02377323, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.

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