Double-Blind Extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with rebif New Formulation (REFLEXION) - REFLEXIO

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 492

Inclusion Criteria

Reach scheduled end of study in study 27025 (completion of 24 month participation. Medical assessment by the Investigator/terating physician from study 27025 that there is no objection to the subject`s participation in this extension trial considering the medical experience from study 27025. Special attention should be given to laboratory abnormalities and clinically significant liver, renal and bone-marrow dysfunction If female subject must: be neither pregnant nor breast feeding, nor attempting to conceive, use a highly effective method of contraception. a highly effective method of contraception is defined as thosewhich result in a low failure rate (i.e. less than 1% per year) when use consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner subject is willing to follow study procedures subject has given written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

subject has any disease other than MS that could better explain the subject`s signs and symptoms subject has a primary progressive course of MS Subjects has total bilirubin > 2,5 times upper limit of normal both at month 24 and at the previous visit (i.e. month 21) (subjects with > 2,5 times upper limit of normal at month 24 only are eligible for enrollment and should be managed as per label reccommendations until normalisation of the value) suject has total aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase >2.5 times the upper limit of normal values at both month 24 and at the previous visit (i.e. month 21) (subjects with > 2,5 times upper limit of normal at month 24 only are eligible for enrollment and should be managed as per label reccommendations until normalisation of the value) subject suffers from another current autoimmune disease subject suffers from major medical or psychiatric illness (including history of, or current, severe depressive disorders and/or suicidal ideation) that in the opinion of the investigator cerates unique risk to the subject or could affect compliance with the study protocol subject has a history of seizures not adequately controlled by treatment subject has cardiac disease such as angina, congestive heart failure or arrythmia subject has a known allergy to IFN-beta or the excipient(s) of the study medication subject has any condition that could interfere with the MRI evaluation subject has a known allergy to gadolinium-DTPA subject has a histry of alcohol or drug abuse subject has previously participated in this study subject has moderate to severe renal impairment subject is pregnant or lactating subject has any medical, psychiatric or other conditions that compromise his/her ability to understand the subject information, to give informed consent, to comply with the study protocol, or to complete the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method