Phase 2
Completed N=128
Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide
Source: ClinicalTrials.gov NCT01403376 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination — 97.5; 97.4; 97.7; 90.0 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination |
97.5; 97.4; 97.7; 90.0; 76.9; 90.7 | — |
| SECONDARY Percentage of Participants With 2 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination |
35.0; 30.8; 46.5; 35.0; 41.0; 51.2 | — |
| SECONDARY Percentage of Participants With 4 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination |
22.5; 20.5; 39.5; 25.0; 23.1; 41.9 | — |
| SECONDARY Geometric Mean of Titers (GMT) Ratio Post/Pre Vaccination |
2.5; 2.3; 3.4; 2.6; 2.6; 4.1 | — |
| SECONDARY Immunoglobulin Levels |
1.28; 1.23; 1.14; 1.30; 1.27; 1.16 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01403376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.