Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
What it found
The main measure showed a statistically significant benefit.
“The median number of combined unique active lesions per scan was 0.5, 0.2, and 0.3 in the placebo, teriflunomide 7 mg/day (p < 0.03 vs placebo), and teriflunomide 14 mg/day (p < 0.01 vs placebo) groups during the 36-week double-blind treatment phase.”Read by software from the paper's abstract
36 weeks
| Group | n | Value |
|---|---|---|
| placebo | 0.5 | |
| teriflunomide 7 mg/day | 0.2 | |
| teriflunomide 14 mg/day | 0.3 |
p = < 0.03 (7 mg/day vs placebo); p < 0.01 (14 mg/day vs placebo)
Total participants: 179
Read by software from the paper's abstract
What was tested
Treatment tested
- Teriflunomide
Dihydroorotate dehydrogenase inhibitor
Placebo or sham
- Placebo (placebo for teriflunomide)
What it measured
Main measures
MRI assessment: number of unique active lesions per scan (T2/proton density and gadolinium-enhanced T1 scan analysis)
36 weeks
MRI lesionsOverview of Adverse Events [AE]
from first study drug intake up to 6 weeks after last intake or entry in the extension study, whichever came first
Safety
Other measures (6)
MRI assessment: number of T1-enhancing lesions per scan
36 weeks
MRI lesionsMRI assessment: number of T2-lesions per scan
36 weeks
MRI lesionsMRI assessment: Number of participants with no new lesions
36 weeks
MRI lesionsMRI assessment: Change from baseline in T2 burden of disease
36 weeks
MRI lesionsNumber of participants with progression on Expanded Disability Status Scale [EDSS]
36 weeks
Disability progressionBladder, bowel and sexual functionNumber of participants with MS relapse confirmed by Scripps Neurological Rating Scale [NRS] and EDSS scores.
36 weeks
Disability progressionRelapsesWalking and mobilityBladder, bowel and sexual functionMood and sleep
Who could take part
MS (type not specified) · 18 to 65
Inclusion Criteria: * Clinically confirmed multiple sclerosis [MS]; * Expanded Disability Status Scale [EDSS] score less or equal to 6; * Two documented relapses in the previous 3 years, and one clinical relapse during the preceding year; * Screening magnetic resonance imaging [MRI] scan fulfilling the criteria for a diagnosis of MS. Exclusion Criteria: * Clinically relevant cardiovascular, hepatic, hematologic, neurological, endocrine or other major systemic disease; * Pregnant or nursing woman; * Wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation); * Prior treatment with interferon [IFN], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial; * 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. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses. Secondary objectives were: * To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI) variables as well as clinical and quality of life measures. * To investigate the pharmacokinetic and pharmacodynamic relationships.
Papers
Results
Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis.BMC Neurol · 2020
Results
O'Connor PW, Li D, Freedman MS, Bar-Or A, Rice GP, Confavreux C, Paty DW, Stewart JA, Scheyer R; Teriflunomide Multiple Sclerosis Trial Group; University of British Columbia MS/MRI Research Group. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology. 2006 Mar 28;66(6):894-900. doi: 10.1212/01.wnl.0000203121.04509.31.The median number of combined unique active lesions per scan was 0.5, 0.2, and 0.3 in the placebo, teriflunomide 7 mg/day (p < 0.03 vs placebo), and teriflunomide 14 mg/day (p < 0.01 vs placebo) groups during the 36-week double-blind treatment phase.
Read by software from the paper's abstract
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History
Started
Apr 2001
Main results due
Mar 2003
Finished
Mar 2003
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