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

NCT ID: NCT01403376

Last Updated: 2016-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-01-31

Brief 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.

Detailed 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Teriflunomide 7 mg

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

Group Type: EXPERIMENTAL

teriflunomide

Intervention Type: DRUG

Film-coated tablet

Oral administration

Influenza vaccine

Intervention Type: BIOLOGICAL

Inactivated, split-virion influenza vaccine 2011-2012

One administration by intramuscular or intradermal route as per product specification

Teriflunomide 14 mg

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

Group Type: EXPERIMENTAL

teriflunomide

Intervention Type: DRUG

Film-coated tablet

Oral administration

Influenza vaccine

Intervention Type: BIOLOGICAL

Inactivated, split-virion influenza vaccine 2011-2012

One administration by intramuscular or intradermal route as per product specification

IFN-β-1

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

Group Type: ACTIVE_COMPARATOR

Interferon-β-1

Intervention Type: DRUG

Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection

Influenza vaccine

Intervention Type: BIOLOGICAL

Inactivated, split-virion influenza vaccine 2011-2012

One administration by intramuscular or intradermal route as per product specification

Interventions

teriflunomide

Film-coated tablet

Oral administration

Intervention Type: DRUG

Interferon-β-1

Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection

Intervention Type: DRUG

Influenza vaccine

Inactivated, split-virion influenza vaccine 2011-2012

One administration by intramuscular or intradermal route as per product specification

Intervention Type: BIOLOGICAL

Other Intervention Names

HMR1726; Rebif®; Avonex®; Betaseron®; Betaferon®; Extavia®; Genfaxone®

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 040001

Vienna, , Austria

Investigational Site Number 124005

Calgary, , Canada

Investigational Site Number 124003

Greenfield Park, , Canada

Investigational Site Number 124002

London, , Canada

Investigational Site Number 124007

Montreal, , Canada

Investigational Site Number 124008

Ottawa, , Canada

Investigational Site Number 124001

Québec, , Canada

Investigational Site Number 124009

Toronto, , Canada

Investigational Site Number 276003

Berlin, , Germany

Investigational Site Number 276001

Essen, , Germany

Investigational Site Number 276002

Münster, , Germany

Investigational Site Number 643002

Nizhny Novgorod, , Russia

Investigational Site Number 804002

Ivano-Frankivsk, , Ukraine

Investigational Site Number 804001

Kharkiv, , Ukraine

Countries

Austria; Canada; Germany; Russia; Ukraine

References

Bar-Or A, Freedman MS, Kremenchutzky M, Menguy-Vacheron F, Bauer D, Jodl S, Truffinet P, Benamor M, Chambers S, O'Connor PW. Teriflunomide effect on immune response to influenza vaccine in patients with multiple sclerosis. Neurology. 2013 Aug 6;81(6):552-8. doi: 10.1212/WNL.0b013e31829e6fbf. Epub 2013 Jul 12.

Reference Type: RESULT

PMID: 23851964 (View on PubMed)

Other Identifiers

2011-001160-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1115-2742

Identifier Type: OTHER

Identifier Source: secondary_id

PDY11684

Identifier Type: -

Identifier Source: org_study_id