Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis

CompletedPhase 2MS (type not specified)NCT00489489 2006-003134-14

What it found

Main goal was not benefit

The main measure was safety, drug levels or similar, not whether the treatment works.

“The primary objective was to evaluate safety; secondary objectives were to evaluate the effects of treatment on disease activity assessed by MRI and relapse rate.”

Read by software from the paper's abstract

24 weeks

Group	n	Value
placebo		4.9% TEAEs led to treatment discontinuation

Total participants: 118

Read by software from the paper's abstract

What was tested

Treatment tested

Teriflunomide
Dihydroorotate dehydrogenase inhibitor
Interferon beta-1a
Interferon alpha/beta receptor agonist

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	Number analysed
Placebo + IFN-β	35 participants	41
Teriflunomide 7 mg + IFN-β	33 participants	37
Teriflunomide 14 mg + IFN-β	32 participants	38
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	2 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + IFN-β	0 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	1 participants	37
Teriflunomide 14 mg + IFN-β	1 participants	38

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	Number analysed
Placebo + IFN-β	24 participants	41
Teriflunomide 7 mg + IFN-β	25 participants	37
Teriflunomide 14 mg + IFN-β	26 participants	38
Placebo + IFN-β	5 participants	41
Teriflunomide 7 mg + IFN-β	8 participants	37
Teriflunomide 14 mg + IFN-β	11 participants	38
Placebo + IFN-β	5 participants	41
Teriflunomide 7 mg + IFN-β	2 participants	37
Teriflunomide 14 mg + IFN-β	7 participants	38
Placebo + IFN-β	0 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + IFN-β	13 participants	41
Teriflunomide 7 mg + IFN-β	18 participants	37
Teriflunomide 14 mg + IFN-β	19 participants	38
Placebo + IFN-β	0 participants	41
Teriflunomide 7 mg + IFN-β	3 participants	37
Teriflunomide 14 mg + IFN-β	3 participants	38
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	4 participants	38
Placebo + IFN-β	4 participants	41
Teriflunomide 7 mg + IFN-β	1 participants	37
Teriflunomide 14 mg + IFN-β	3 participants	38
Placebo + IFN-β	5 participants	41
Teriflunomide 7 mg + IFN-β	3 participants	37
Teriflunomide 14 mg + IFN-β	3 participants	38
Placebo + IFN-β	0 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + IFN-β	0 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38

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	Number analysed
Placebo + IFN-β	2 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	2 participants	38
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	1 participants	38
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	1 participants	38
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + IFN-β	0 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + IFN-β	0 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

Group	Participants at risk	Serious adverse events
Placebo + IFN-β	41	1 (2.4%)
Teriflunomide 7 mg + IFN-β	37	2 (5.4%)
Teriflunomide 14 mg + + IFN-β	38	0 (0.0%)

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)
Safety
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)
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 lesions
Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)
24 weeks
MRI lesions
Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan
24 weeks
MRI lesions
Annualized Relapse Rate [ARR]: Poisson Regression Estimates
24 weeks
Disability progressionRelapses
Pharmacokinetic [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 IFN-β 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 with placebo, in patients with multiple sclerosis [MS] with relapses who were on a stable dose of interferon-β [IFN-β]. Secondary objectives were: * to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in combination with a stable dose of IFN-β 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 IFN-β.

Papers

Results
Freedman MS, Wolinsky JS, Wamil B, Confavreux C, Comi G, Kappos L, Olsson TP, Miller A, Benzerdjeb H, Li H, Simonson C, O'Connor PW; Teriflunomide Multiple Sclerosis Trial Group and the MRI Analysis Center. Teriflunomide added to interferon-beta in relapsing multiple sclerosis: a randomized phase II trial. Neurology. 2012 Jun 5;78(23):1877-85. doi: 10.1212/WNL.0b013e318258f7d4. Epub 2012 May 23.
The primary objective was to evaluate safety; secondary objectives were to evaluate the effects of treatment on disease activity assessed by MRI and relapse rate.
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…
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Links found where a registry record names another trial's registry number.

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History

Started
May 2007
Main results due
Jun 2009
Finished
Jun 2009
Results posted
Nov 2012

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