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| Name | Class |
|---|---|
| Merck A.E., Greece | INDUSTRY |
The present study aims to assess the adherence to therapy with interferon beta-1a (Rebif®) and at investigating potential factors that are involved in its outcome, in a representative sample of patients with relapsing remitting multiple sclerosis (RRMS), under real life conditions.
In the relapsing-remitting type of the disease the objective of the therapy is the reduction of relapse rate, duration and severity, as well as the delay of transition to the progressive form of the disease. Subjects' adherence to long-term therapy of MS plays a pivotal role in the optimization of therapeutic outcome and maximization of the derived clinical benefit for the treated subjects. Rebif current formulation has been developed by assessing and refining the physicochemical characteristics of existing formulations aiming at further improving product's tolerability profile. Studies performed for the assessment of Rebif have demonstrated a 3-fold reduction in injection site reactions as well as improved overall tolerability and safety profile.
This is a multicentre, prospective, non interventional, non randomized, open label study for the assessment of the adherence to therapy with Rebif of subjects with RRMS. The participating subjects shall be already on treatment with (Rebif) prior to their enrolment into the study, according to the approved Summary of Product Characteristics (SPC) and the clinical, imaging and laboratory findings of the disease, as evaluated by their treating physician, in real life clinical practice. Data will be collected retrospectively from a sample of 150 subjects' medical files and through questions that will be posed to the subjects, and prospectively during the course of the study. The total duration of the study is estimated to be 18 months.
OBJECTIVES
Primary objective:
Secondary objective:
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of subjects' compliance with physicians' instructions on the proper use of the treatment | Evaluation of the actual number of injections administered during the preceding 2 weeks prior to subjects' enrolment into the study | Preceding 2 weeks prior to subjects enrolment into the study |
| Assessment of subjects' compliance with physicians' instructions on the proper use of the treatment after 6 months of therapy | Evaluation of the number of injections actually administered over the preceding 2 weeks prior to the first and the final visit of the study | From preceding 2 weeks prior to the first visit (Month 1) till the final visit (Month 6) of the study |
| Assessment of subjects' persistence to therapy | Assessment will include recording of the number of days under treatment since subjects' enrolment into the study and until the performance of the study final visit, at Month 6. | Since subjects' enrolment until final study visit (Month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the factors and their potential correlation with the defined subjects' compliance and persistence to therapy | Subject's training regarding proper administration of the study drug and proper use of auto-injector of the study drug (Rebiject II); implementation by subject of the recommendations for treatment administration and instructions on the proper use of device (via prefilled syringe or auto-injector); prophylactic use of non steroidal anti-inflammatory drugs (NSAIDs); reasons for missed injections; EDSS score at baseline; relapse history prior to Rebif therapy initiation; MS treatments received by the subject during the preceding year before Rebif therapy commencement |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with documented diagnosis of RRMS according to the McDonald criteria (2005)
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| Name | Affiliation | Role |
|---|---|---|
| Michalis Arvanitis, MD | Merck A.E., Greece | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Dunant Hospital - IRB | Athens | 11526 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18728744 | Background | Manfredonia F, Pasquali L, Dardano A, Iudice A, Murri L, Monzani F. Review of the clinical evidence for interferon beta 1a (Rebif) in the treatment of multiple sclerosis. Neuropsychiatr Dis Treat. 2008 Apr;4(2):321-36. doi: 10.2147/ndt.s476. | |
| 15916455 | Background | Murdoch D, Lyseng-Williamson KA. Subcutaneous recombinant interferon-beta-1a (Rebif): a review of its use in relapsing-remitting multiple sclerosis. Drugs. 2005;65(9):1295-312. doi: 10.2165/00003495-200565090-00010. |
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| Subjects' enrollment to final study visit (Month 6) |
| 16053475 | Background | Gold R, Rieckmann P, Chang P, Abdalla J; PRISMS Study Group. The long-term safety and tolerability of high-dose interferon beta-1a in relapsing-remitting multiple sclerosis: 4-year data from the PRISMS study. Eur J Neurol. 2005 Aug;12(8):649-56. doi: 10.1111/j.1468-1331.2005.01083.x. |
| 16441244 | Background | Cramer JA, Cuffel BJ, Divan V, Al-Sabbagh A, Glassman M. Patient satisfaction with an injection device for multiple sclerosis treatment. Acta Neurol Scand. 2006 Mar;113(3):156-62. doi: 10.1111/j.1600-0404.2005.00568.x. |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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