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

January 21, 2016 updated by: Sanofi

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Wien, Austria, 1010
        • Investigational Site Number 040001
      • Calgary, Canada, T2N 2T9
        • Investigational Site Number 124005
      • Greenfield Park, Canada, J4V 2J2
        • Investigational Site Number 124003
      • London, Canada, N6A 5A5
        • Investigational Site Number 124002
      • Montreal, Canada, H3A 2B4
        • Investigational Site Number 124007
      • Ottawa, Canada, K1H 8L6
        • Investigational Site Number 124008
      • Quebec, Canada, G1J 1Z4
        • Investigational Site Number 124001
      • Toronto, Canada, M5B 1W8
        • Investigational Site Number 124009
      • Berlin, Germany, 10785
        • Investigational Site Number 276003
      • Essen, Germany, 45122
        • Investigational Site Number 276001
      • Münster, Germany, 48149
        • Investigational Site Number 276002
      • Nizhny Novgorod, Russian Federation, 603076
        • Investigational Site Number 643002
      • Ivano-Frankovsk, Ukraine, 76008
        • Investigational Site Number 804002
      • Kharkiv, Ukraine, 61018
        • Investigational Site Number 804001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teriflunomide 7 mg
Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months

Film-coated tablet

Oral administration

Other Names:
  • HMR1726

Inactivated, split-virion influenza vaccine 2011-2012

One administration by intramuscular or intradermal route as per product specification

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

Film-coated tablet

Oral administration

Other Names:
  • HMR1726

Inactivated, split-virion influenza vaccine 2011-2012

One administration by intramuscular or intradermal route as per product specification

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

Inactivated, split-virion influenza vaccine 2011-2012

One administration by intramuscular or intradermal route as per product specification

Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Other Names:
  • Rebif®
  • Extavia®
  • Avonex®
  • Betaseron®
  • Betaferon®
  • Genfaxone®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With 2 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination
Time Frame: pre vaccination (baseline) and 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
Percentage of Participants With 4 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination
Time Frame: pre vaccination (baseline) and 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
Geometric Mean of Titers (GMT) Ratio Post/Pre Vaccination
Time Frame: pre vaccination (baseline) and 28 days post vaccination
pre vaccination (baseline) and 28 days post vaccination
Immunoglobulin Levels
Time Frame: pre vaccination (baseline) and 28 days post vaccination
pre vaccination (baseline) and 28 days post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 26, 2011

First Posted (Estimate)

July 27, 2011

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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