Transition to Rebif New Formulation

Condition(s) targeted: Relapsing Multiple Sclerosis

Intervention: Rebif New Formulation + prophylactically Ibuprofen (Drug); Rebif New Formulation + ibuprofen PRN (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: EMD Serono

Official(s) and/or principal investigator(s):
Sabine Latoure, MD, Study Director, Affiliation: Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany

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

Official title: A Randomized, Multicenter, Two-Arm, Open-Label, Phase IIIb Study to Evaluate the Satisfaction in Relapsing Multiple Sclerosis Subjects Transitioning to Rebif® New Formulation From Rebif® (Interferon Beta-1a) With Ibuprofen PRN or as Prophylaxis

Study design: Supportive Care, Randomized, Open Label, Parallel Assignment

Primary outcome: Patient Satisfaction

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject with relapsing forms of Multiple Sclerosis

- EDSS score < 5. 5 at study entry

- Subjects who have been administering Rebif 44mcg tiw 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 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:

Local Medical Information, Paris, France

Local Medical Information, Munich, Germany

Starting date: June 2007
Last updated: February 8, 2008