Phase 3
N=1,169
An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00751881 ↗Enrolled (actual)
1,169
Serious AEs
11.5%
Results posted
Jun 2013
Primary outcome: Primary: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate — 0.501; 0.389; 0.319 relapses per year — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Teriflunomide (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate |
0.501; 0.389; 0.319 | 0.0001 sig |
| SECONDARY Core Treatment Period: Time to Disability Progression |
8.0; 5.3; 2.7; 14.2; 12.1; 7.8 | 0.0442 sig |
| SECONDARY Core Treatment Period: Time Without Relapse |
76.4; 81.5; 85.5; 60.6; 71.9; 76.3 | — |
| SECONDARY Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score |
0.089; 0.042; -0.050 | — |
| SECONDARY Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score |
4.669; 2.512; 1.915 | — |
| SECONDARY Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score |
6.311; 4.464; 2.043 | — |
| SECONDARY Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores |
-1.082; -0.397; -0.105; -2.913; -2.031; -1.434 | — |
| SECONDARY Core Treatment Period: Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores |
-1.629; -0.909; -0.638; -2.792; -1.704; -1.087 | — |
| SECONDARY Core Treatment Period: Overview of Adverse Events |
320; 344; 320; 47; 52; 44 | — |
| SECONDARY Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE) |
203; 200; 188; 16; 33; 29 | — |
| SECONDARY Extension Treatment Period: Time to Disability Progression |
0.130; 0.117; 0.077; 0.190; 0.175; 0.147 | — |
| SECONDARY Extension Treatment Period: ARR: Poisson Regression Estimate |
0.199; 0.200; 0.179 | — |
Summary
The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.
Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.
Other secondary objectives were:
* To assess the effect of the two doses of teriflunomide in comparison to placebo on:
* Fatigue;
* Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
* To evaluate the safety and tolerability of teriflunomide.
Eligibility Criteria
Inclusion Criteria
- Relapsing multiple sclerosis,
- Two relapses in prior 2 years or one relapse in prior year.
Exclusion Criteria
- Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
- Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
- Pregnant or nursing woman,
- Alcohol or drug abuse,
- Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
- Human immunodeficiency virus (HIV) positive,
- 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 (NCT00751881). 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.