Rehabilitation Study in MS Patients

Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®

Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical ability of patients with and without FRP.

Inclusion Criteria:

• Female and Male patients aged 18 and more;
• Confirmed diagnosis of RRMS according to the MacDonald or Poser criteria;
• First indication for Betaferon treatment (as described in Summary of Product Characteristics (SmPC));
• No relapse of multiple sclerosis (MS) in the last two months before the inclusion;
• Walking patients having an Expanded Disability Status Scale (EDSS) score between > 1 and </= 4 at the inclusion visit;
• Female of child-bearing potential must agree to practice adequate contraception methods over all the duration of the study;
• Patient can follow all the study and comply with all procedures of the trial protocol
• Laboratory evaluations (i.e. evaluation of hepatic enzymes gammaGT, full blood count and differential white blood cell [WBC]) must be available and the results must be normal;
• Written informed consent.

Exclusion Criteria:

• Any contraindication to Betaferon as described in the SmPC of the product;
• Patient with a previously orthopaedic surgical intervention within the past year of the inclusion;
• Patient previously included in this study;
• Patient previously treated within the past 3 months with Rebif, Avonex or Copaxone;
• Patient previously treated within the past 12 months with Betaferon;
• Participation in any clinical trial within the past 30 days involving the investigational drug intake.