Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis
What it found
The main measure was safety, drug levels or similar, not whether the treatment works.
“Teriflunomide added to stable-dose GA had acceptable safety and tolerability, and reduced some MRI markers of disease activity compared with GA alone.”Read by software from the paper's abstract
| Group | n | Value |
|---|---|---|
| Teriflunomide 14 mg | 40 | 5 (12.2%) discontinued treatment due to AEs |
| Placebo | 41 | 2 (5.0%) discontinued treatment due to AEs |
Total participants: 123
Read by software from the paper's abstract
What was tested
Treatment tested
- Teriflunomide
Dihydroorotate dehydrogenase inhibitor
- Glatiramer acetate
Unknown
Placebo or sham
- Placebo (for teriflunomide)
Results by group
Overview of Adverse Events (AE]
from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo + GA | 32 participants | 41 | |
| Teriflunomide 7 mg + GA | 35 participants | 42 | |
| Teriflunomide 14 mg + GA | 35 participants | 40 | |
| Placebo + GA | 3 participants | 41 | |
| Teriflunomide 7 mg + GA | 3 participants | 42 | |
| Teriflunomide 14 mg + GA | 1 participants | 40 | |
| Placebo + GA | 0 participants | 41 | |
| Teriflunomide 7 mg + GA | 0 participants | 42 | |
| Teriflunomide 14 mg + GA | 0 participants | 40 | |
| Placebo + GA | 0 participants | 41 | |
| Teriflunomide 7 mg + GA | 3 participants | 42 | |
| Teriflunomide 14 mg + GA | 4 participants | 40 |
Overview of AE With Potential Risk of Occurrence
from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo + GA | 24 participants | 41 | |
| Teriflunomide 7 mg + GA | 28 participants | 42 | |
| Teriflunomide 14 mg + GA | 28 participants | 40 | |
| Placebo + GA | 4 participants | 41 | |
| Teriflunomide 7 mg + GA | 2 participants | 42 | |
| Teriflunomide 14 mg + GA | 5 participants | 40 | |
| Placebo + GA | 6 participants | 41 | |
| Teriflunomide 7 mg + GA | 5 participants | 42 | |
| Teriflunomide 14 mg + GA | 6 participants | 40 | |
| Placebo + GA | 0 participants | 41 | |
| Teriflunomide 7 mg + GA | 1 participants | 42 | |
| Teriflunomide 14 mg + GA | 0 participants | 40 | |
| Placebo + GA | 18 participants | 41 | |
| Teriflunomide 7 mg + GA | 18 participants | 42 | |
| Teriflunomide 14 mg + GA | 15 participants | 40 | |
| Placebo + GA | 1 participants | 41 | |
| Teriflunomide 7 mg + GA | 5 participants | 42 | |
| Teriflunomide 14 mg + GA | 7 participants | 40 | |
| Placebo + GA | 0 participants | 41 | |
| Teriflunomide 7 mg + GA | 1 participants | 42 | |
| Teriflunomide 14 mg + GA | 0 participants | 40 | |
| Placebo + GA | 2 participants | 41 | |
| Teriflunomide 7 mg + GA | 1 participants | 42 | |
| Teriflunomide 14 mg + GA | 5 participants | 40 | |
| Placebo + GA | 3 participants | 41 | |
| Teriflunomide 7 mg + GA | 3 participants | 42 | |
| Teriflunomide 14 mg + GA | 8 participants | 40 | |
| Placebo + GA | 0 participants | 41 | |
| Teriflunomide 7 mg + GA | 0 participants | 42 | |
| Teriflunomide 14 mg + GA | 0 participants | 40 | |
| Placebo + GA | 1 participants | 41 | |
| Teriflunomide 7 mg + GA | 3 participants | 42 | |
| Teriflunomide 14 mg + GA | 1 participants | 40 |
Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)
from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo + GA | 1 participants | 41 | |
| Teriflunomide 7 mg + GA | 0 participants | 42 | |
| Teriflunomide 14 mg + GA | 1 participants | 40 | |
| Placebo + GA | 1 participants | 41 | |
| Teriflunomide 7 mg + GA | 0 participants | 42 | |
| Teriflunomide 14 mg + GA | 1 participants | 40 | |
| Placebo + GA | 1 participants | 41 | |
| Teriflunomide 7 mg + GA | 0 participants | 42 | |
| Teriflunomide 14 mg + GA | 0 participants | 40 | |
| Placebo + GA | 1 participants | 41 | |
| Teriflunomide 7 mg + GA | 0 participants | 42 | |
| Teriflunomide 14 mg + GA | 0 participants | 40 | |
| Placebo + GA | 1 participants | 41 | |
| Teriflunomide 7 mg + GA | 0 participants | 42 | |
| Teriflunomide 14 mg + GA | 0 participants | 40 | |
| Placebo + GA | 0 participants | 41 | |
| Teriflunomide 7 mg + GA | 0 participants | 42 | |
| Teriflunomide 14 mg + GA | 0 participants | 40 | |
| Placebo + GA | 0 participants | 41 | |
| Teriflunomide 7 mg + GA | 0 participants | 42 | |
| Teriflunomide 14 mg + GA | 0 participants | 40 | |
| Placebo + GA | 0 participants | 41 | |
| Teriflunomide 7 mg + GA | 0 participants | 42 | |
| Teriflunomide 14 mg + GA | 0 participants | 40 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Placebo + GA | 41 | 3 (7.3%) | |
| Teriflunomide 7 mg + GA | 42 | 3 (7.1%) | |
| Teriflunomide 14 mg + GA | 40 | 1 (2.5%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Overview of Adverse Events (AE]
from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)
SafetyOverview of AE With Potential Risk of Occurrence
from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)
Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)
from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)
Safety (adverse event reports; physical examination and laboratory evaluation)
Safety
Other measures (5)
Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)
baseline (before randomization) and 24 weeks
MRI lesionsCerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)
24 weeks
MRI lesionsCerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan
24 weeks
MRI lesionsAnnualized Relapse Rate [ARR]: Poisson Regression Estimates
24 weeks
Disability progressionRelapsesPharmacokinetic [PK]: Teriflunomide Plasma Concentration
24 weeks
How the body handles the medicine
Who could take part
MS (type not specified) · 18 to 55
Inclusion Criteria: * Definite MS diagnosis according to McDonald's criteria; * Relapsing clinical course, with or without progression; * Expanded Disability Status Scale [EDSS] less or equal to 5.5 (ambulatory); * Stable dose of Glatiramer Acetate [GA] for at least 26 weeks prior to the screening visit; * No onset of MS relapse in the preceding 60 days prior to randomization; * Clinically stable for 4 weeks prior to randomization. Exclusion Criteria: * Other chronic disease of the immune system, liver function impairment or chronic pancreatic disease; * 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; * Human immunodeficiency virus [HIV] positive status; * 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 was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with multiple sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA]. The secondary objectives were: * to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in combination with a stable dose of GA on Magnetic Resonance Imaging [MRI] parameters, relapse rate and patient-reported fatigue; * to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of GA.
Papers
Results
Freedman MS, Wolinsky JS, Truffinet P, Comi G, Kappos L, Miller AE, Olsson TP, Benamor M, Chambers S, O'Connor PW. A randomized trial of teriflunomide added to glatiramer acetate in relapsing multiple sclerosis. Mult Scler J Exp Transl Clin. 2015 Dec 7;1:2055217315618687. doi: 10.1177/2055217315618687. eCollection 2015 Jan-Dec.Teriflunomide added to stable-dose GA had acceptable safety and tolerability, and reduced some MRI markers of disease activity compared with GA alone.
Read by software from the paper's abstract
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Linked trials
Extended by
Long Term Safety of Teriflunomide When Added to Interfero…Phase 2 · Completed
Links found where a registry record names another trial's registry number.
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History
Started
Apr 2007
Main results due
Oct 2009
Finished
Oct 2009
Results posted
Nov 2012
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