Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis

CompletedPhase 2MS (type not specified)NCT00811395 2007-003997-24

What it found

Main goal was not benefit

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

“Teriflunomide was well tolerated over 48 weeks.”

Read by software from the paper's abstract

48 weeks

Group	n	Value
Teriflunomide 14 mg	40	5 (12.2%) discontinued due to AEs
Placebo	41	2 (5.0%) discontinued due to AEs

Total participants: 123

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
Glatiramer acetate
Unknown

Placebo or sham

Placebo (for teriflunomide)

Results by group

Overview of Adverse Events [AE]

from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)

Group	Value	Number analysed
Placebo + IFN-β	35 participants	41
Teriflunomide 7 mg + IFN-β	35 participants	37
Teriflunomide 14 mg + IFN-β	33 participants	38
Placebo + GA	39 participants	40
Teriflunomide 7 mg + GA	40 participants	42
Teriflunomide 14 mg + GA	38 participants	41
Placebo + IFN-β	2 participants	41
Teriflunomide 7 mg + IFN-β	4 participants	37
Teriflunomide 14 mg + IFN-β	1 participants	38
Placebo + GA	6 participants	40
Teriflunomide 7 mg + GA	5 participants	42
Teriflunomide 14 mg + GA	2 participants	41
Placebo + IFN-β	0 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + GA	0 participants	40
Teriflunomide 7 mg + GA	0 participants	42
Teriflunomide 14 mg + GA	0 participants	41
Placebo + IFN-β	2 participants	41
Teriflunomide 7 mg + IFN-β	3 participants	37
Teriflunomide 14 mg + IFN-β	3 participants	38
Placebo + GA	2 participants	40
Teriflunomide 7 mg + GA	3 participants	42
Teriflunomide 14 mg + GA	5 participants	41

Overview of AE With Potential Risk of Occurence

from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)

Group	Value	Number analysed
Placebo + IFN-β	28 participants	41
Teriflunomide 7 mg + IFN-β	30 participants	37
Teriflunomide 14 mg + IFN-β	30 participants	38
Placebo + GA	34 participants	40
Teriflunomide 7 mg + GA	33 participants	42
Teriflunomide 14 mg + GA	32 participants	41
Placebo + IFN-β	7 participants	41
Teriflunomide 7 mg + IFN-β	11 participants	37
Teriflunomide 14 mg + IFN-β	13 participants	38
Placebo + GA	5 participants	40
Teriflunomide 7 mg + GA	4 participants	42
Teriflunomide 14 mg + GA	5 participants	41
Placebo + IFN-β	16 participants	41
Teriflunomide 7 mg + IFN-β	21 participants	37
Teriflunomide 14 mg + IFN-β	20 participants	38
Placebo + GA	27 participants	40
Teriflunomide 7 mg + GA	22 participants	42
Teriflunomide 14 mg + GA	21 participants	41
Placebo + IFN-β	8 participants	41
Teriflunomide 7 mg + IFN-β	5 participants	37
Teriflunomide 14 mg + IFN-β	11 participants	38
Placebo + GA	6 participants	40
Teriflunomide 7 mg + GA	6 participants	42
Teriflunomide 14 mg + GA	11 participants	41
Placebo + IFN-β	0 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + GA	0 participants	40
Teriflunomide 7 mg + GA	0 participants	42
Teriflunomide 14 mg + GA	0 participants	41
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	3 participants	37
Teriflunomide 14 mg + IFN-β	4 participants	38
Placebo + GA	1 participants	40
Teriflunomide 7 mg + GA	5 participants	42
Teriflunomide 14 mg + GA	7 participants	41
Placebo + IFN-β	0 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + GA	0 participants	40
Teriflunomide 7 mg + GA	1 participants	42
Teriflunomide 14 mg + GA	0 participants	41
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	4 participants	37
Teriflunomide 14 mg + IFN-β	6 participants	38
Placebo + GA	0 participants	40
Teriflunomide 7 mg + GA	2 participants	42
Teriflunomide 14 mg + GA	2 participants	41
Placebo + IFN-β	5 participants	41
Teriflunomide 7 mg + IFN-β	3 participants	37
Teriflunomide 14 mg + IFN-β	4 participants	38
Placebo + GA	4 participants	40
Teriflunomide 7 mg + GA	5 participants	42
Teriflunomide 14 mg + GA	10 participants	41
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	1 participants	37
Teriflunomide 14 mg + IFN-β	2 participants	38
Placebo + GA	3 participants	40
Teriflunomide 7 mg + GA	3 participants	42
Teriflunomide 14 mg + GA	1 participants	41
Placebo + IFN-β	6 participants	41
Teriflunomide 7 mg + IFN-β	4 participants	37
Teriflunomide 14 mg + IFN-β	4 participants	38
Placebo + GA	4 participants	40
Teriflunomide 7 mg + GA	6 participants	42
Teriflunomide 14 mg + GA	10 participants	41

Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA]

from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)

Group	Value	Number analysed
Placebo + IFN-β	2 participants	41
Teriflunomide 7 mg + IFN-β	1 participants	37
Teriflunomide 14 mg + IFN-β	3 participants	38
Placebo + GA	1 participants	40
Teriflunomide 7 mg + GA	0 participants	42
Teriflunomide 14 mg + GA	1 participants	41
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	1 participants	38
Placebo + GA	1 participants	40
Teriflunomide 7 mg + GA	0 participants	42
Teriflunomide 14 mg + GA	1 participants	41
Placebo + IFN-β	0 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + GA	1 participants	40
Teriflunomide 7 mg + GA	0 participants	42
Teriflunomide 14 mg + GA	0 participants	41
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	1 participants	38
Placebo + GA	1 participants	40
Teriflunomide 7 mg + GA	0 participants	42
Teriflunomide 14 mg + GA	0 participants	41
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + GA	0 participants	40
Teriflunomide 7 mg + GA	0 participants	42
Teriflunomide 14 mg + GA	0 participants	41
Placebo + IFN-β	1 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + GA	0 participants	40
Teriflunomide 7 mg + GA	0 participants	42
Teriflunomide 14 mg + GA	0 participants	41
Placebo + IFN-β	0 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + GA	0 participants	40
Teriflunomide 7 mg + GA	0 participants	42
Teriflunomide 14 mg + GA	0 participants	41
Placebo + IFN-β	0 participants	41
Teriflunomide 7 mg + IFN-β	0 participants	37
Teriflunomide 14 mg + IFN-β	0 participants	38
Placebo + GA	0 participants	40
Teriflunomide 7 mg + GA	0 participants	42
Teriflunomide 14 mg + GA	0 participants	41

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	2 (4.9%)
Teriflunomide 7 mg + IFN-β	37	4 (10.8%)
Teriflunomide 14 mg + IFN-β	38	1 (2.6%)
Placebo + GA	40	6 (15.0%)
Teriflunomide 7 mg + GA	42	5 (11.9%)
Teriflunomide 14 mg + GA	41	2 (4.9%)

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 in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)
Safety
Overview of AE With Potential Risk of Occurence
from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)
Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA]
from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)
Safety ( Adverse event reports,laboratory parameters,ECG,CT of MRI image of pancreas and vitals signs)
MRI lesionsSafety

Other measures (6)

Annualized Relapse Rate [ARR]: Poisson Regression Estimates
48 weeks
Disability progressionRelapses
Overview of 12-week Sustained Disability Progression
48 weeks
Disability progression
Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints
48 weeks
Disability progression
Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)
baseline (before randomization in PDY6045 or PDY6046) and 48 weeks
MRI lesions
Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)
48 weeks
MRI lesions
Cerebral MRI Assessment: Total Volume of Gd-enhancing T1-lesions Per Scan
48 weeks
MRI lesions

Who could take part

MS (type not specified) · 18 to 55

Inclusion Criteria: * PDY6045 or PDY6046 participant who: * completed the week 24 visit of either study PDY6045 or PDY6046, * was still meeting eligibility criteria for receiving treatment, * had agreed to continue stable dose of Interferon-β [IFN-β] or Glatiramer Acetate [GA] and consented to continue on treatment. Exclusion Criteria: * Any known condition or circumstance that would have prevented in the investigator's opinion, compliance or completion of the study The above information is not intended to contain all considerations relevant to 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 evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β [IFN-β] or glatiramer Acetate [GA] in patients with multiple sclerosis [MS] with relapses. Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging [MRI] parameters. This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.

Papers

Loading reviews and guidelines…

Linked trials

Extension of
Phase II Study of Teriflunomide as Adjunctive Therapy to …
Phase 2 · Completed
Extension of
Phase II Study of Teriflunomide as Adjunctive Therapy to …
Phase 2 · Completed

Links found where a registry record names another trial's registry number.

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History

Started
Oct 2007
Main results due
Apr 2010
Finished
Apr 2010
Results posted
Dec 2012

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