Transition to Rebif New Formulation

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 When Necessary (PRN) or as Prophylaxis”

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.

Intervention(s) in this Clinical Trial

• Drug: Rebif New Formulation + prophylactic Ibuprofen
  • 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
• Drug: Rebif New Formulation + ibuprofen PRN
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Transition with prophylactic ibuprofen
• Active Comparator: Transition with PRN ibuprofen

Primary Measures

• Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score
  • Time Frame: 4 weeks
    Safety Issue?: No
• Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score
  • Time Frame: 4 weeks
    Safety Issue?: No
• Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score
  • Time Frame: 4 weeks
    Safety Issue?: Yes
• Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score
  • Time Frame: 4 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck KGaA Industry

Overall Clinical Trial Officials and Contacts

Sabine Latour, MD Study Director Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00619307

Study ID Number: 27571

ClinicalTrials.gov Identifier: NCT00619307

Health Authority: France: Afssaps - French Health Products Safety Agency