Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Participants completing the EFC6049 (HMR1726D/3001) study were given the opportunity to continue in the extension study;
* participants receiving teriflunomide 7 mg or 14 mg were blindly maintained on the same dose of teriflunomide.
* participants receiving placebo were randomized at a 1:1 ratio to teriflunomide 7 mg or 14 mg.
The study period per participant was broken down as follows:
* Double-blind treatment: up to a maximum of 288 weeks or until teriflunomide was commercially available in the country where participant lived,
* Post-washout follow-up: 4 weeks after last treatment intake. No post-washout follow up if participant continued on teriflunomide treatment by obtaining its commercial form after end of the study.
The total duration of the extension was 292 weeks (about 6 years) from the first participant enrolled or until teriflunomide is commercially available in the country where participant lived.
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant who completed the previous double-blind placebo-controlled study EFC6049 and who did not meet criteria for treatment withdrawal.
Willingness to participate in a long-term safety/efficacy trial.
You may not be if
Any known condition or circumstance that would prevent in the investigator's opinion, compliance or completion of the study.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Clareo Health | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis