An Observational Study for the Assessment of Compliance and Persistence to Rebif® Therapy of Patients With Relapsing-remitting Multiple Sclerosis (MS) and Evaluation of Potential Factors Influencing These Parameters
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.
Multiple Sclerosis, Relapsing-Remitting
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Multicentre, Non Interventional, Non Randomized, Observational Study for the Assessment of Compliance and Persistence With Rebif® Therapy of Patients With Relapsing-Remitting Multiple Sclerosis as Well as for the Evaluation of Potential Factors Influencing These Parameters, in Real Life Clinical Practice|
- Assessment of subjects' compliance with physicians' instructions on the proper use of the treatment [ Time Frame: Preceding 2 weeks prior to subjects enrolment into the study ] [ Designated as safety issue: No ]Evaluation of the actual number of injections administered during the 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 [ Time Frame: From preceding 2 weeks prior to the first visit (Month 1) till the final visit (Month 6) of the study ] [ Designated as safety issue: No ]Evaluation of the number of injections actually administered over the preceding 2 weeks prior to the first and the final visit of the study
- Assessment of subjects' persistence to therapy [ Time Frame: Since subjects' enrolment until final study visit (Month 6) ] [ Designated as safety issue: No ]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.
- Assessment of the factors and their potential correlation with the defined subjects' compliance and persistence to therapy [ Time Frame: Subjects' enrollment to final study visit (Month 6) ] [ Designated as safety issue: No ]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
|Study Start Date:||December 2009|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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.
- To assess the compliance and persistence with Rebif therapy in MS subjects, after six months of therapy, in "real life" clinical settings in Greece
- To investigate the potential factors influencing compliance and persistence to Rebif therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112345
|Henry Dunant Hospital - IRB|
|Athens, Greece, 11526|
|Study Director:||Michalis Arvanitis, MD||Merck A.E., Greece|