Transition to Rebif New Formulation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Relapsing Multiple Sclerosis

Intervention / Treatment
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* Drug: Rebif New Formulation + prophylactic Ibuprofen
* Drug: Rebif New Formulation + ibuprofen PRN


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transition with prophylactic ibuprofen<br> | Drug: Rebif New Formulation + prophylactic Ibuprofen<br>* 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<br>|
| Active Comparator: Transition with PRN ibuprofen<br> | Drug: Rebif New Formulation + ibuprofen PRN<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score | This is defined as the sum of the scores for the side effects section questions 1-4, with a minimum possible total score of 1 and a maximum possible total score of 20 in the MSTCQ. The lower the score, the better the outcome. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score | This is defined as the sum of the scores for the injection systems section questions 1-9 and the side effects section questions 1-11, with a minimum possible total score of 20 and a maximum possible total score of 100. The lower the score, the better the outcome. | 4 weeks | 
| Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score | This is defined as the sum of the scores for the injection systems section questions 1-9, with a minimum possible total score of 9 and a maximum possible total score of 45. The lower the score, the better the outcome. | 4 weeks | 
| Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score | This is defined as the sum of the scores for the side effects section questions 5 to 8, with a minimum possible total score of 1 and a maximum possible total score of 20. The lower the score, the better the outcome. | 4 weeks | 
| Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score | This is defined as the sum of the scores for side effects section questions 9 to 11, corresponding to minimum possible total score of 3 and a maximum possible total score of 15. The lower the score, the better the outcome. | 4 weeks |