Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide (TERIVA)

Sanofi

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Interferon-β-1; Biological: Influenza vaccine; Drug: teriflunomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01403376

U1111-1115-2742 (Other Identifier)

PDY11684

2011-001160-21 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

The maximum duration of the study period for a participant was approximatively 49 days broken down as follows:

• Screening period of up to 21 days;
• Influenza vaccination at Day 1;
• Follow-up period of 28 days (±2 days).

MS treatment (Teriflunomide or interferon-β-1) was to be continued during the course of the study.

Enrollment: 128 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

128 participants in 3 patient groups

Teriflunomide 7 mg

Experimental group

Description:

Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months

Treatment:

Drug: teriflunomide

Biological: Influenza vaccine

Teriflunomide 14 mg

Experimental group

Description:

Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months

Treatment:

Drug: teriflunomide

Biological: Influenza vaccine

IFN-β-1

Active Comparator group

Description:

Influenza vaccine in participants treated with a stable dose of Interferon-β-1 (IFN-β-1) for at least 6 months

Treatment:

Drug: Interferon-β-1

Biological: Influenza vaccine