Clinical trial NCT00619307 (phase 3, status: completed)
Conditions: relapsing multiple sclerosis
ICD codes: M94.1, A68.9, A68.0, A68.1, M35.6
Drugs: rebif new formulation + prophylactic ibuprofen, rebif new formulation + ibuprofen prn
SMILES: CC1=CC(O)=CC(C)=C1Cl, CC1=CC(O)=CC(C)=C1Cl
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