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TOWER

A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis
CompletedPhase 3Relapsing MSNCT007518812007-004452-36

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression EstimateRelative risk reduction (%) 36.30.0001
Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression EstimateRelative Risk Reduction (%) 22.30.0183

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Placebo or sham

  • Placebo

Results by group

Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate

Core treatment period between 48 - 152 weeks depending on time of enrollment

GroupValueIntervalNumber analysed
Placebo0.501 relapses per year0.432–0.581388
Teriflunomide 7 mg0.389 relapses per year0.332–0.457407
Teriflunomide 14 mg0.319 relapses per year0.267–0.381370

Placebo

0.501

Teriflunomide 7 mg

0.389

Teriflunomide 14 mg

0.319

p = 0.0001; Relative risk reduction (%) 36.3

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo38547 (12.2%)
Teriflunomide 7 mg40952 (12.7%)
Teriflunomide 14 mg37144 (11.9%)
Placebo / 14 mg25116 (6.4%)
Teriflunomide 7 mg / 14 mg26733 (12.4%)
Teriflunomide 14 mg / 14 mg23329 (12.4%)

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

  • Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate

    Core treatment period between 48 - 152 weeks depending on time of enrollment

    Disability progressionRelapses

  • Annualized relapse rate, defined as the number of relapses per patient-year.

    Relapses

Other measures (12)

  • Core Treatment Period: Time to Disability Progression

    Core treatment period between 48 - 152 weeks depending on time of enrollment

    Disability progression

  • Core Treatment Period: Time Without Relapse

    Core treatment period between 48 - 152 weeks depending on time of enrollment

    Disability progressionRelapses

  • Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score

    Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48

    Disability progressionBladder, bowel and sexual function

  • Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score

    Baseline (before randomization), Week 12, Week 24 and Week 48

    Disability progressionThinking and memoryFatigue

  • Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score

    Baseline (before randomization) and up to Week 152

    Disability progressionFatigue

  • Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores

    Baseline (before randomization), Week 12, Week 24 and Week 48

    Disability progressionPainQuality of life (reported by participants)

  • Core Treatment Period: Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores

    Baseline (before randomization) and up to Week 152

    Disability progressionQuality of life (reported by participants)

  • Core Treatment Period: Overview of Adverse Events

    From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first

    Safety

  • Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE)

    From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period

    Safety

  • Extension Treatment Period: Time to Disability Progression

    Core treatment period (maximum: 173 weeks) and Extension treatment period (maximum: 174 weeks)

    Disability progression

Who could take part

Relapsing MS · 18 to 55

Inclusion Criteria: * Relapsing multiple sclerosis, * Two relapses in prior 2 years or one relapse in prior year. Exclusion Criteria: * Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease, * Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia, * Pregnant or nursing woman, * Alcohol or drug abuse, * Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate, * Human immunodeficiency virus (HIV) positive, * 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 the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS. Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression. Other secondary objectives were: * To assess the effect of the two doses of teriflunomide in comparison to placebo on: * Fatigue; * Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being. * To evaluate the safety and tolerability of teriflunomide.

Papers

Loading reviews and guidelines…

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History

    1. Started

      Aug 2008

    2. Main results due

      Apr 2012

    3. Finished

      Aug 2015

    4. Results posted

      Jun 2013

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