Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01403376
Recruitment Status : Completed
First Posted : July 27, 2011
Results First Posted : February 26, 2013
Last Update Posted : February 18, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE July 14, 2011
First Posted Date  ICMJE July 27, 2011
Results First Submitted Date  ICMJE January 22, 2013
Results First Posted Date  ICMJE February 26, 2013
Last Update Posted Date February 18, 2016
Study Start Date  ICMJE September 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
Number of patients achieving seroprotection (antibody titer ≥40) [ Time Frame: 28 days ]
Change History Complete list of historical versions of study NCT01403376 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
  • 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.
  • 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.
  • Geometric Mean of Titers (GMT) Ratio Post/Pre Vaccination [ Time Frame: pre vaccination (baseline) and 28 days post vaccination ]
  • Immunoglobulin Levels [ Time Frame: pre vaccination (baseline) and 28 days post vaccination ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
  • Number of patients with an antibody titer increase of 2 fold or more [ Time Frame: Baseline and 28 days ]
  • Number of patients with an antibody titer increase of 4 fold or more [ Time Frame: Baseline and 28 days ]
  • Change of immunoglobulins (IgM, IgG, IgA) from baseline [ Time Frame: Baseline and 28 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: teriflunomide

    Film-coated tablet

    Oral administration

    Other Name: HMR1726
  • Drug: Interferon-β-1
    Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
    Other Names:
    • Rebif®
    • Avonex®
    • Betaseron®
    • Betaferon®
    • Extavia®
    • Genfaxone®
  • Biological: Influenza vaccine

    Inactivated, split-virion influenza vaccine 2011-2012

    One administration by intramuscular or intradermal route as per product specification

Study Arms  ICMJE
  • Experimental: Teriflunomide 7 mg
    Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
    Interventions:
    • Drug: teriflunomide
    • Biological: Influenza vaccine
  • Experimental: Teriflunomide 14 mg
    Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
    Interventions:
    • Drug: teriflunomide
    • Biological: Influenza vaccine
  • 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
    Interventions:
    • Drug: Interferon-β-1
    • Biological: Influenza vaccine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2012)
128
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2011)
120
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   Germany,   Russian Federation,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01403376
Other Study ID Numbers  ICMJE PDY11684
2011-001160-21 ( EudraCT Number: UTN )
U1111-1115-2742 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP