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 B.V., Netherlands
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female, 18 to 65 years of age (both inclusive), at the time of informed consent
Participants diagnosed with RRMS according to McDonald criteria 2010
Participants have discontinued treatment with dimethyl fumarate (Tecfidera), teriflunomide (Aubagio), glatiramer acetate (Copaxone®), intramuscular IFNβ-1a (Avonex®), pegylated interferon (Plegridy®), subcutaneous IFNβ-1b (Betaferon®) or fingolimod (Gilenya®) within 6 months prior to Visit 1
* Currently treated with Rebif using RebiSmart 2.0, for a maximum of 6 months prior to Visit 1
* Participants have a score on the Expanded Disability Status Scale (EDSS) between 0 to 5.0 inclusive
* Participants willing and able to give informed consent.
You may not be if
Participants have known planned surgical procedures at the time of the informed consent that will prevent adherence to treatment with Rebif through RebiSmart 2.0
Participants diagnosed with primary progressive, secondary progressive, or progressive relapsing MS
pregnant or lactating, or planning to become pregnant subjects
In the opinion of the Investigator has significant renal or hepatic impairment or other significant disease (e.g., cognitive or visual impairment) that would compromise adherence and completion of the study
Reports any reason that he/she cannot complete the 1 year study
Participants have a history of hypersensitivity to natural or recombinant interferon, or any other component of the formulation
Participants who contraindicated for the treatment with subcutaneous IFNβ-1a therapy as per summary of product characteristics or currently approved specific country product information
Participants have any other factor that in the opinion of the Investigator would make the subject unsuitable for participation in this study
Participants have significant psychiatric symptoms that, in the opinion of the Investigator, would impact patient ability to comply with treatment recommendations.
