Relapsing multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Conditions
Interventions
Trade Name: NA
Product Name: Interferon-beta 1a FBS-free/HSA-free, RNF
Product Code: NA
Pharmaceutical Form: Solution for injection
Sponsors
Merck Serono International SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject with Relapsing Forms of MS (RMS) EDSS score =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Secondary Progressive Multiple Sclerosis (SPMS) 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 1 Subject received corticosteroids or 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) or alkaline phosphatase > 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 (including current, severe disorders and/or suicidal ideation) that in the opinion of the investigator could affect compliance with the study protocol Subject is pregnant or attempting to conceive Visual or physical impairment that precludes completion of diaries and questionnaires by himself/herself Contraindication to ibuprofen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To obtain clinical experience with the transition to RNF in order to provide physicians with recommendations how to best manage this transition through the use of concomitant ibuprofen.;Primary end point(s): The primary endpoint is the FLS score from the MSTCQ at week 4. This is defined as the sum of the scores for “side effects” section questions 1-4, corresponding to a maximum total score of 20.;Main Objective: To assess subject satisfaction by the MS Treatment Concern Questionnaire (MSTCQ) specifically measuring Flu Like Symptoms (FLS) during the first 4 weeks after subjects transitioned to RNF in 2 treatment groups: one treatment group receives ibuprofen prophylactically and the other ibuprofen PRN. | — |
Countries
France, Germany
Outcome results
None listed