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TERIVA

Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide Treatment and Using a Population of Patients With Multiple Sclerosis as a Reference
CompletedPhase 2Relapsing MSNCT014033762011-001160-21

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Teriflunomide

    Dihydroorotate dehydrogenase inhibitor

  • Influenza vaccine
  • Mutagrip

Compared with

Results by group

Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination

28 days post vaccination

GroupValueIntervalNumber analysed
Teriflunomide 7 mg97.5 percentage of participants93.4–10040
Teriflunomide 14 mg97.4 percentage of participants93.3–10039
IFN-β-197.7 percentage of participants93.9–10043
Teriflunomide 7 mg90.0 percentage of participants82.2–97.840
Teriflunomide 14 mg76.9 percentage of participants65.8–8839
IFN-β-190.7 percentage of participants83.4–9843
Teriflunomide 7 mg97.5 percentage of participants93.4–10040
Teriflunomide 14 mg97.4 percentage of participants93.3–10039
IFN-β-193.0 percentage of participants86.6–99.443

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Teriflunomide 7mg410 (0.0%)
Teriflunomide 14mg410 (0.0%)
IFN-β-1460 (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

  • Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination

    28 days post vaccination

    Immune response

  • Number of patients achieving seroprotection (antibody titer ≥40)

    Immune response

Other measures (5)

  • Percentage of Participants With 2 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination

    pre vaccination (baseline) and 28 days post vaccination

    Immune response

  • Percentage of Participants With 4 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination

    pre vaccination (baseline) and 28 days post vaccination

    Immune response

  • Geometric Mean of Titers (GMT) Ratio Post/Pre Vaccination

    pre vaccination (baseline) and 28 days post vaccination

  • Immunoglobulin Levels

    pre vaccination (baseline) and 28 days post vaccination

  • • Number of patients with an antibody titer increase of 2 fold or more

    Immune response

Who could take part

Relapsing MS · 18 to 59

Inclusion Criteria: - Male or female patient \<60 years old with relapsing multiple sclerosis (RMS) either treated for at least 6 months with 7 or 14 mg teriflunomide in one of the studies LTS6048 or LTS6050, or treated with a stable dose of interferon-β-1 for at least 6 months. Exclusion Criteria: * Concomitant infectious pathology at the time of vaccination; * MS relapse within 1 month before vaccination; * Systemic corticosteroids within 1 month before the vaccination; * Any contraindication to influenza vaccine; * Any vaccination within the last 6 months; * Prior use of any investigational drug or participation to a clinical trial within 1 year (only for patients under interferon-β-1); * Prior or concomitant use (for a minimum of 1 year before study entry) of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, natalizumab (Tysabri®), leflunomide or fingolimod or other immunomodulator/immunosuppressant in development; * Prior or concomitant use of glatiramer acetate within 1 year before study entry; * Prior or concomitant use of intravenous immunoglobulins within 3 months before study entry; * Pregnant or breast feeding women; * Woman of childbearing potential without adequate contraception. 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

Primary Objective: Assess the antibody response to influenza vaccine in patients with relapsing form of multiple sclerosis (RMS) treated with teriflunomide compared to a reference population. Secondary Objectives: * Assess the effect of teriflunomide on immunoglobulin levels; * Assess the safety of influenza vaccination in patients with RMS treated with teriflunomide. The reference population was defined as multiple sclerosis (MS) patients with a stable treatment with interferon-β-1. Antibody response was measured using hemagglutination inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1, and B as present in the influenza vaccine used.

Papers

Loading reviews and guidelines…

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History

    1. Started

      Sept 2011

    2. Main results due

      Jan 2012

    3. Finished

      Jan 2012

    4. Results posted

      Feb 2013

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