A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Rebif®; Rebif®
Intervention description: Rebif® will be administered at a dose of 44 microgram (mcg) subcutaneously three times a week in the morning using RebiSmart® self-injector device for 12 weeks.; Rebif® will be administered at a dose of 44 mcg subcutaneously three times a week in the evening using RebiSmart® self-injector device for 12 weeks.
Intervention MeSH terms: Interferon beta-1a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis, Relapsing-Remitting; Interferon beta 1a; Rebif®

Summary:

      This is an open-label, multi-center, 12-week, randomized, controlled, parallel group, Phase 4
      study to assess whether the morning administration of interferon beta 1a (Rebif®) leads to a
      lower severity of flu-like symptoms (FLS) as compared to the evening administration, in
      subjects with relapsing multiple sclerosis (RMS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between 18 and 60 years of age

          -  Female subjects must be neither pregnant nor breast-feeding and must lack
             child-bearing potential. Furthermore, female subjects must not have been pregnant from
             at least three months prior to enter in the study

          -  Subjects have RMS according to the revised McDonald Criteria (2010)

          -  Subjects with an expanded disability status scale (EDSS) score of less than 6.0

          -  Subjects naive to treatment and eligible for treatment with Rebif® 44 three times a
             week, or patients having received glatiramer acetate with a wash-out from at least one
             month, or patients having received treatment with natalizumab or fingolimod with a
             wash-out from at least three months

          -  Subjects able to self-inject treatment using RebiSmart®

          -  Subjects willing and able to comply with the protocol for the duration of the study

          -  Subjects have given written informed consent to take part in the study

        Exclusion Criteria:

          -  Subjects have any disease other than MS that could better explain his/her signs and
             symptoms

          -  Subjects who have received any immunosuppressive agents within 3 months prior to
             Baseline

          -  Subjects who have received any corticosteroids within 30 days prior to Baseline

          -  Subjects have a MS relapse within 30 days prior to Baseline

          -  Subjects have inadequate liver function and bone marrow reserve as defined in the
             protocol

          -  Subjects have moderate to severe renal impairment

          -  Subjects have any visual or physical impairment that precludes the subjects from
             self-injecting the treatment using RebiSmart®

          -  Subjects have hypersensitivity to natural or recombinant interferon, or to any of its
             excipients

          -  Subjects have any contra-indications to treatment with interferon (IFN) beta 1a
             according to Summary of Product Characteristics (SmPC)

          -  Subjects have any contra-indications to treatment with ibuprofen/paracetamol according
             to SmPC

          -  Obese subjects, defined by body mass index greater than 30 kilogram per square meter
             (kg/m^2)

          -  Subjects have participated in any other investigational trial within 30 days from
             Baseline

          -  Subjects have any other significant disease that in the Investigator's opinion would
             exclude the subject from the trial