A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects (SCANSMART)
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Neurology Clinics at Danish and Norwegian hospitals (single treatment group)
Males and females between 18 and 65 years of age
Have relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald Criteria (2005)
Having an expanded disability status scale (EDSS) of less than 6 at the screening visit or within 2 months prior to the screening visit
Stable treatment (defined as treatment after titration period) with RebiSmart administered Rebif new formulation (RNF) 22/44 mcg subcutaneously thrice a week for a minimum of 4 weeks prior to inclusion
Previously treated with disease modifying drugs (DMDs) for a minimum of 6 months prior to the screening visit
Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined by either:
Post-menopausal or surgically sterile; or
Using a highly effective method of contraception for the duration of the study. This is defined as a method that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly , and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD), sexual abstinence or vasectomized partner
Have a scheduled visit 12 weeks after the inclusion visit
Willing and able to comply with the protocol for the duration of the study
Have given written informed consent
Have had a relapse within 30 days prior to the first visit
Have any contra-indications to treatment with Interferon-beta 1a according to Summary of Product Characteristics
Have any other significant disease that in the Investigator's opinion would exclude the subject from the trial