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Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses
CompletedPhase 3Relapsing MSNCT008030492006-003361-14

What it found

Main goal was not benefit

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

“In the TEMSO extension, safety observations were consistent with the core trial, with no new or unexpected AEs in patients receiving teriflunomide for up to 9 years.”
Read by software from the paper's abstract

up to 9 years

Total participants: 742

Read by software from the paper's abstract

What was tested

Treatment tested

Results by group

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

Baseline (LTS6050) up to 28 days after last dose of study drug up to 450 weeks

GroupValueIntervalNumber analysed
Placebo/Teriflunomide 7 mg93.8 percentage of participants129
Teriflunomide 7 mg/7 mg91.3 percentage of participants254
Placebo/Teriflunomide 14 mg94.4 percentage of participants107
Teriflunomide 14 mg/14 mg91.2 percentage of participants250
Placebo/Teriflunomide 7 mg24.8 percentage of participants129
Teriflunomide 7 mg/7 mg28.0 percentage of participants254
Placebo/Teriflunomide 14 mg21.5 percentage of participants107
Teriflunomide 14 mg/14 mg24.8 percentage of participants250
Placebo/Teriflunomide 7 mg2.3 percentage of participants129
Teriflunomide 7 mg/7 mg0.8 percentage of participants254
Placebo/Teriflunomide 14 mg0 percentage of participants107
Teriflunomide 14 mg/14 mg0.8 percentage of participants250
Placebo/Teriflunomide 7 mg17.1 percentage of participants129
Teriflunomide 7 mg/7 mg12.2 percentage of participants254
Placebo/Teriflunomide 14 mg12.1 percentage of participants107
Teriflunomide 14 mg/14 mg10.8 percentage of participants250

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo/Teriflunomide 7 mg12932 (24.8%)
Teriflunomide 7 mg/7 mg25471 (28.0%)
Placebo/Teriflunomide 14 mg10723 (21.5%)
Teriflunomide 14 mg/14 mg25062 (24.8%)

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

  • Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Baseline (LTS6050) up to 28 days after last dose of study drug up to 450 weeks

    Safety

  • The primary endpoint is the safety of teriflunomide. Number of patients with adverse events

    Safety

Other measures (6)

  • Time to 12 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP

    Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)

    Disability progression

  • Time to 24 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP

    Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)

    Disability progression

  • Percentage of Participants Free of Sustained Disability Progression (DP)

    Up to 10.8 years since EFC6049 randomization (EFC6049: 108 weeks + LTS6050: 450 weeks)

    Disability progressionBladder, bowel and sexual function

  • Annualized MS Relapse Rate (ARR): Poisson Regression Estimates

    Up to 8 years since LTS6050 randomization

    Disability progressionRelapsesFatigue

  • Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Volume of Abnormal Lesions (Burden of Disease [BOD]) at Week 192 Since LTS6050 Randomization

    Baseline, Week 192

    MRI lesions

  • 1) Time to disability progression as assessed by Expanded Disability Status Scale (EDSS)

    Disability progression

Who could take part

Relapsing MS · 18 to 55

Inclusion Criteria: * Participant who completed the previous double-blind placebo-controlled study EFC6049 and who did not meet criteria for treatment withdrawal. * Willingness to participate in a long-term safety/efficacy trial. Exclusion Criteria: * 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 participant'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 document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse. The secondary objective was to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.

Papers

Loading reviews and guidelines…

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History

    1. Started

      Oct 2006

    2. Main results due

      Dec 2015

    3. Finished

      Dec 2015

    4. Results posted

      Jan 2017

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