Clareo Health | A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects
A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck KGaA, Darmstadt, Germany
With
Merck Serono Norway
Smerud Medical Research International AS
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
