Multiple sclerosis MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who have completed the last study visit of the previous study (EFC6049) and do not meet criteria for treatment withdrawal - Female patients of childbearing potential must agree to comply with the contraception requirement described in section 7.4 of the protocol. - Female patients have demonstrated not to be pregnant by serum pregnancy test or breast feeding at the time of study entry. - McDonald's criteria must continue to support the diagnosis of clinically definite MS (see protocol appendix A). - An informed consent must be obtain in writing from the patient for this extension study prior to enrollment. Patients must demonstrate a willingness and ability to participate in a long term safety and efficacy trial with the opportunity to continue treatment on either 7 mg or 14 mg/day of teriflunomide under double-blind conditions, until availability of the results for study EFC6049 (HMR1726D/3001). Patients must actively refuse existing approved therapies. In addition a supplemental HIV-testing informed consent will be required for patients who have not yet signed it in the main study (EFC6049) in order to have an HIV testing at baseline and yearly. 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 1080 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients who do not complete the EFC6049 (HMR1726D/3001) study. - Patients who developed clinically relevant cardiovascular, hepatic, endocrine, or other major systematic disease making implementation of the protocol or interpretation of the study results difficult or that would put the patient at risk by participing in the study. - Any known condition or circumstance that would prevent in the investigator's opinion, compliance or completion of the study. - Pregnancy - Breast-feeding - Women of child-bearing potential, except if they satisfy all conditions described in protocol section7.4. - Patients wishing to parent children during the course of the trial, or following the trial except if they agree to follow the appropriate drug washout procedure when they stop their study participation (protocol section 10.2) - Patients requiring treatment during the study period with drugs not permitted by the study protocol (Protocol section 8.9.2) - Prior use within 4 weeks before randomization or concomitant use of cholestyramine and/or activated charcoal - Patients with a history of recent and clinically significant drug or alcohol abuse - Liver function impairment or persisting ALT or direct bilirubin elevations of more than 1.5-fold the upper limit of normal - Mental conditions rendering the patient unable to understand the nature, scope and possible consequence of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To document the long-term safety and tolerability of two doses of teriflunomide (7 and 14 mg) in MS patients with relapses. ;Secondary Objective: To document the long-term effect on disability progression (key secondary endpoint), annual relapse rate and MRI variables.;Primary end point(s): The primary endpoint is the safety of teriflunomide. Number of patients with adverse events;Timepoint(s) of evaluation of this end point: Up to a maximum of 336 weeks (+ 4-week follow-up period). | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Up to a maximum of 336 weeks.; Secondary end point(s): 1) Time to disability progression as assessed by Expanded Disability Status Scale (EDSS) 2) Proportion of patients free of disability progression 3) Annualized relapse rate (number of confirmed relapses per patientyear) 4) Burden of disease : Change from baseline in the volume of abnormal brain tissue as measured by brain MRI | — |
Countries
Austria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Russian Federation, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactMedical Information
sanofi-aventis recherche & développement
Outcome results
None listed