Clinical trial NCT01403376: Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-07-27
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

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.

Primary outcomes:
measure: Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination
timeFrame: 28 days post vaccination
Secondary outcomes:
measure: Percentage of Participants With 2 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination
timeFrame: pre vaccination (baseline) and 28 days post vaccination
measure: Percentage of Participants With 4 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination
timeFrame: pre vaccination (baseline) and 28 days post vaccination
measure: Geometric Mean of Titers (GMT) Ratio Post/Pre Vaccination
timeFrame: pre vaccination (baseline) and 28 days post vaccination
measure: Immunoglobulin Levels
timeFrame: pre vaccination (baseline) and 28 days post vaccination
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Investigational Site Number 040001
city: Calgary
country: Canada
facility: Investigational Site Number 124005
city: Greenfield Park
country: Canada
facility: Investigational Site Number 124003
city: London
country: Canada
facility: Investigational Site Number 124002
city: Montreal
country: Canada
facility: Investigational Site Number 124007
city: Ottawa
country: Canada
facility: Investigational Site Number 124008
city: Quebec
country: Canada
facility: Investigational Site Number 124001
city: Toronto
country: Canada
facility: Investigational Site Number 124009
city: Berlin
country: Germany
facility: Investigational Site Number 276003
city: Essen
country: Germany
facility: Investigational Site Number 276001
city: Münster
country: Germany
facility: Investigational Site Number 276002
city: Nizhny Novgorod
country: Russian Federation
facility: Investigational Site Number 643002
city: Ivano-Frankovsk
country: Ukraine
facility: Investigational Site Number 804002
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.