EUCTR2011-001160-21-DE
Active, not recruiting
Not Applicable
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 - TERIVA
sanofi-aventis recherche & developpement0 sites120 target enrollmentMay 20, 2011
ConditionsTherapeutic area: Diseases [C] - Nervous System Diseases [C10]Multiple sclerosisMedDRA version: 14.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
DrugsMutagrip
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Sponsor
- sanofi-aventis recherche & developpement
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients \<60 years old 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
Outcomes
Primary Outcomes
Not specified
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