Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

• Number of patients with adverse events [ Time Frame: Up to a maximum of 292 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives ] [ Designated as safety issue: Yes ]
  

• Time to disability progression as assessed by Expanded Disability Status Scale (EDSS) [ Time Frame: Up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives ] [ Designated as safety issue: No ]
  
• Proportion of patients free of disability progression [ Time Frame: Up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives ] [ Designated as safety issue: No ]
  
• Annualized relapse rate (number of confirmed relapses per patient-year) [ Time Frame: Up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives ] [ Designated as safety issue: No ]
  
• Burden of disease : Change from baseline in the volume of abnormal brain tissue as measured by brain MRI [ Time Frame: Up to a maximum of 288 weeks ] [ Designated as safety issue: No ]
  

Patients completing the EFC6049 (HMR1726D/3001) study are given the opportunity to continue in the extension study;

• patients receiving teriflunomide 7 mg or 14 mg are blindly maintained on the same dose of teriflunomide.
• patients receiving placebo are randomized to teriflunomide 7 mg or 14 mg.

The study period per patient is broken down as follows:

• Double-blind treatment: up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives,
• Post-washout follow-up: 4 weeks after last treatment intake. No post-washout follow up if patient continues on teriflunomide treatment by obtaining it's commercial form after end of the study.

The total duration of the extension is 292 weeks (about 6 years) from the first patient enrolled or until teriflunomide is commercially available in the country where patient lives.