Transition to Rebif New Formulation
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Rebif New Formulation + prophylactic Ibuprofen; Rebif New Formulation + ibuprofen PRN
Intervention description: Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, receives systematically 400 mg ibuprofen as prophylactic treatment against flu-like symptoms on days when Rebif New Formulation 44 mcg three times a week is injected; Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, should not administer Ibuprofen before the first Rebif New Formulation injection. If flu-like symptoms occur after the 44 mcg Rebif New Formulation injection then the subject can administer 400 mg ibuprofen. This should only be administered after the Rebif New Formulation injection and not before the Rebif New Formulation injection.
Intervention MeSH terms: Interferon beta-1a; Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      To assess patient satisfaction with respect to the incidence of flu-like symptoms (FLS) in
      patients with multiple sclerosis transitioned from current Rebif (subcutaneously injected
      interferon beta-1a, 44 mcg three-times-weekly) to the new formulation of Rebif (RNF) while
      receiving ibuprofen either prophylactically or only when necessary (PRN) after the occurence
      of flu-like symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject with relapsing forms of Multiple Sclerosis (MS)

          -  Expanded disability status scale (EDSS) score < 5.5 at study entry

          -  Subjects who have been administering Rebif 44 mcg three times a week for at least 6
             months prior to study enrolment

          -  Subject currently using Rebiject II and who will use their own Rebiject II for the
             Rebif New Formulation injections

          -  Subject is between 18 and 60 years old inclusive

          -  Female subjects must be neither pregnant nor breast-feeding and must lack childbearing
             potential, as defined by either: post-menopausal or surgically sterile, or use a
             highly effective method of contraception.

          -  Subject is willing to follow study procedures

          -  Subject is willing and must not present any contra-indication to taking ibuprofen
             during 4 weeks of the study

          -  Subject has given written informed consent

        Exclusion Criteria:

          -  Secondary Progressive Multiple Sclerosis without superimposed attacks

          -  Use of any other injectible medications during the week prior to the screening period,
             during the screening or treatment periods

          -  Subject receiving MS therapy in addition (i.e. combination therapy) to Rebif within 3
             months prior to study enrolment or at any time during study protocol

          -  History of any chronic pain syndrome

          -  Subjects that use any investigational drug or experimental procedure within 12 weeks
             of visit

          -  Subject received corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days
             of visit 1

          -  Subject with flu-like symptoms (FLS) associated with any cause (i.e. no current flu
             and no FLS related to Interferon in the week prior to baseline)

          -  Subject has abnormal liver function, defined by a total bilirubin > 1.5 times the
             upper limit of normal, aspartate aminotransferase (AST) or alanine aminotransferase
             (ALT) > 2.5 times the upper limit of the normal values.

          -  Subject has inadequate bone marrow reserve, defined as a total white blood cell count
             < 3.0 x 109/L, platelet count < 75 x 109/L, haemoglobin < 100 g/L.

          -  Subject suffers from an active autoimmune disease other than MS

          -  Subject suffers from major medical or psychiatric illness

          -  Subject has seizures history or is currently experiencing seizures not adequately
             controlled by anti-epileptics

          -  Subject is pregnant or attempting to conceive

          -  Visual or physical impairment that precludes completion of diaries and questionnaires
             by himself/herself

          -  Contraindication to ibuprofen:known hypersensitivity to the active ingredient
             ibuprofen

          -  Known hypersensitivity to non-steroidal anti-inflammatory drugs which can lead to
             asthmatic attacks, gastric and/or intestinal ulcers, gastro-intestinal bleeding,
             cerebro-vascular bleeding or other active bleeding, severe hepatic dysfunction, severe
             kidney dysfunction, severe cardiac insufficiency, or systemic lupus erythematosus