Transition to Rebif New Formulation

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Ibuprofen; Interferon beta-1a

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