- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01403376
Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide (TERIVA)
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Wien, Austria, 1010
- Investigational Site Number 040001
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Calgary, Canada, T2N 2T9
- Investigational Site Number 124005
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Greenfield Park, Canada, J4V 2J2
- Investigational Site Number 124003
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London, Canada, N6A 5A5
- Investigational Site Number 124002
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Montreal, Canada, H3A 2B4
- Investigational Site Number 124007
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Ottawa, Canada, K1H 8L6
- Investigational Site Number 124008
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Quebec, Canada, G1J 1Z4
- Investigational Site Number 124001
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Toronto, Canada, M5B 1W8
- Investigational Site Number 124009
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Berlin, Germany, 10785
- Investigational Site Number 276003
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Essen, Germany, 45122
- Investigational Site Number 276001
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Münster, Germany, 48149
- Investigational Site Number 276002
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Nizhny Novgorod, Russian Federation, 603076
- Investigational Site Number 643002
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Ivano-Frankovsk, Ukraine, 76008
- Investigational Site Number 804002
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Kharkiv, Ukraine, 61018
- Investigational Site Number 804001
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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Experimental: Teriflunomide 7 mg
Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
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Film-coated tablet Oral administration
Other Names:
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
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Film-coated tablet Oral administration
Other Names:
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
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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:
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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
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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pre vaccination (baseline) and 28 days post vaccination
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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
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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.
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pre vaccination (baseline) and 28 days post vaccination
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Geometric Mean of Titers (GMT) Ratio Post/Pre Vaccination
Time Frame: pre vaccination (baseline) and 28 days post vaccination
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pre vaccination (baseline) and 28 days post vaccination
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Immunoglobulin Levels
Time Frame: pre vaccination (baseline) and 28 days post vaccination
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pre vaccination (baseline) and 28 days post vaccination
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferons
- Interferon-beta
- Interferon beta-1b
- Teriflunomide
Other Study ID Numbers
- PDY11684
- 2011-001160-21 (EudraCT Number: UTN)
- U1111-1115-2742 (Other Identifier: UTN)
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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