transition to rebif new formulation

Conditions: Relapsing Multiple Sclerosis

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