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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01403376
Other study ID # PDY11684
Secondary ID 2011-001160-21U1
Status Completed
Phase Phase 2
First received July 14, 2011
Last updated January 21, 2016
Start date September 2011
Est. completion date January 2012

Study information

Verified date January 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 59 Years
Eligibility 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-ß-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-ß-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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
teriflunomide
Film-coated tablet Oral administration
Interferon-ß-1
Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Biological:
Influenza vaccine
Inactivated, split-virion influenza vaccine 2011-2012 One administration by intramuscular or intradermal route as per product specification

Locations

Country Name City State
Austria Investigational Site Number 040001 Wien
Canada 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 Quebec
Canada Investigational Site Number 124009 Toronto
Germany Investigational Site Number 276003 Berlin
Germany Investigational Site Number 276001 Essen
Germany Investigational Site Number 276002 Münster
Russian Federation Investigational Site Number 643002 Nizhny Novgorod
Ukraine Investigational Site Number 804002 Ivano-Frankovsk
Ukraine Investigational Site Number 804001 Kharkiv

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

Austria,  Canada,  Germany,  Russian Federation,  Ukraine, 

References & Publications (1)

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- — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Antibody Titer =40 at 28 Days Post Vaccination For each viral strain (H1N1, H3N2, and B), the antibody titer, level of antibodies in blood sample when exposed to antigen, was calculated as the mean of two replicates. If the titer was below or above the limit of detection, the threshold value was used.
The percentage of participants achieving a titer of 40 or more, as well as the 90% confidence interval (CI) using normal approximation were calculated for each strain and treatment group.
28 days post vaccination No
Secondary Percentage of Participants With 2 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination Percentages of participants with an increase from baseline of 2-fold or more in antibody titers and 90% CIs using normal approximation were calculated for each strain and treatment group. pre vaccination (baseline) and 28 days post vaccination No
Secondary Percentage of Participants With 4 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination Percentages of participants with an increase from baseline of 4-fold or more in antibody titers and 90% CIs using normal approximation were calculated for each strain and treatment group. pre vaccination (baseline) and 28 days post vaccination No
Secondary Geometric Mean of Titers (GMT) Ratio Post/Pre Vaccination pre vaccination (baseline) and 28 days post vaccination No
Secondary Immunoglobulin Levels pre vaccination (baseline) and 28 days post vaccination No
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