Status:
COMPLETED
Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
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. Second...
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 perio...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01403376
Start Date
September 1 2011
End Date
January 1 2012
Last Update
February 18 2016
Active Locations (14)
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1
Investigational Site Number 040001
Vienna, Austria, 1010
2
Investigational Site Number 124005
Calgary, Canada, T2N 2T9
3
Investigational Site Number 124003
Greenfield Park, Canada, J4V 2J2
4
Investigational Site Number 124002
London, Canada, N6A 5A5