Phase 3
N=742
Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00803049 ↗Enrolled (actual)
742
Serious AEs
25.4%
Results posted
Jan 2017
Primary outcome: Primary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — 93.8; 91.3; 94.4; 91.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Teriflunomide (HMR1726) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
93.8; 91.3; 94.4; 91.2; 24.8; 28.0 | — |
| SECONDARY Time to 12 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP |
0.544; 0.494; 0.627; 0.473 | 0.2079 |
| SECONDARY Time to 24 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP |
0.444; 0.434; 0.518; 0.438 | 0.8017 |
| SECONDARY Percentage of Participants Free of Sustained Disability Progression (DP) |
45.6; 50.6; 37.3; 52.7; 55.6; 56.6 | — |
| SECONDARY Annualized MS Relapse Rate (ARR): Poisson Regression Estimates |
0.216; 0.183; 0.176; 0.160 | — |
| SECONDARY Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Volume of Abnormal Lesions (Burden of Disease [BOD]) at Week 192 Since LTS6050 Randomization |
5.307; 3.969; 3.720; 3.943 | — |
Summary
The primary objective of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse.
The secondary objective was to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00803049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.