Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide

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 - TERIVA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001160-21-DE

Enrollment

120

Registered

2011-05-20

Start date

2011-07-18

Completion date

Unknown

Last updated

2013-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis MedDRA version: 14.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: Teriflunomide Product Code: HMR1726D Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Teriflunomide CAS Number: 108605-62-5 Current Sponsor code: HMR1726D Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male or female patients =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Having 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 Beta-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/immunosupressant 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 • Women of childbearing potential without adequate contraception

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the antibody response to influenza vaccine in patients with relapsing form of multiple sclerosis (RMS) treated with teriflunomide and in a reference population of RMS patients;Secondary Objective: - Assess the effect of teriflunomide on immunoglobulins, - Assess the safety of influenza vaccination in multiple sclerosis (MS) patients treated with teriflunomide ;Primary end point(s): Number of patients achieving seroprotection (antibody titer =40);Timepoint(s) of evaluation of this end point: 28 days	—

Measure

Time frame

Main Objective: Assess the antibody response to influenza vaccine in patients with relapsing form of multiple sclerosis (RMS) treated with teriflunomide and in a reference population of RMS patients;Secondary Objective: - Assess the effect of teriflunomide on immunoglobulins, - Assess the safety of influenza vaccination in multiple sclerosis (MS) patients treated with teriflunomide ;Primary end point(s): Number of patients achieving seroprotection (antibody titer =40);Timepoint(s) of evaluation of this end point: 28 days

—

Secondary

Measure	Time frame
Secondary end point(s): • Number of patients with an antibody titer increase of 2 fold or more • Number of patients with an antibody titer increase of 4 fold or more • Change of immunoglobulins (IgM, IgG, IgA) from baseline;Timepoint(s) of evaluation of this end point: 28 days	—

Countries

Austria, Canada, Germany, Russian Federation, Ukraine

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026