Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide

• Conditions: Multiple sclerosis; MedDRA version: 14.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-001160-21-AT
• Lead Sponsor: sanofi-aventis recherche & developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Male or female patients =18 and <60 years with relapsing forms of multiple sclerosis
- treated for at least 6 months with 7 and 14 mg teriflunomide or
- treated with a stable dose of IFN-ß-1 for at least 6 months
• Patients having signed the specific informed consent form for this study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Having 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 Beta-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/immunosupressant 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
• Women of childbearing potential without adequate contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified