Phase 3
N=1,088
Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00134563 ↗Enrolled (actual)
1,088
Serious AEs
14.3%
Results posted
Nov 2012
Primary outcome: Primary: Annualized Relapse Rate [ARR]: Poisson Regression Estimates — 0.539; 0.370; 0.369 relapses per year — p=0.0005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Teriflunomide (Drug); Placebo (for teriflunomide) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Relapse Rate [ARR]: Poisson Regression Estimates |
0.539; 0.370; 0.369 | 0.0005 sig |
| SECONDARY Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints |
8.6; 5.8; 6.2; 16.0; 13.1; 11.3 | 0.0279 sig |
| SECONDARY Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) |
2.208; 1.308; 0.723; 0.533; 0.499; 0.331 | 0.0003 sig |
| SECONDARY Changes From Baseline in Fatigue Impact Scale [FIS] Total Score |
4.300; 2.343; 3.804 | 0.8271 |
Summary
The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).
Secondary objectives were:
* to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic Resonance Imaging [MRI] and patient-reported fatigue;
* to evaluate the safety and tolerability of teriflunomide.
Eligibility Criteria
Inclusion Criteria
- Multiple sclerosis [MS] subject who was ambulatory (EDSS of ≤ 5.5)
- Exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing);
- Meeting McDonald's criteria for MS diagnosis;
- Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial;
- No relapse onset in the preceding 60 days prior to randomization;
- Clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone [ACTH] or systemic steroid treatment.
Exclusion Criteria
- Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease;
- Significantly impaired bone marrow function;
- Pregnant or nursing woman;
- Alcohol or drug abuse;
- Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
- Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study;
Data sourced from ClinicalTrials.gov (NCT00134563). 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.