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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	4 February 2013
Main ID:	EUCTR2011-001160-21-DE
Date of registration:	20/05/2011
Prospective Registration:	Yes
Primary sponsor:	sanofi-aventis recherche & developpement
Public title:	Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide
Scientific title:	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
Date of first enrolment:	18/07/2011
Target sample size:	120
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001160-21
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Population of patients with multiple sclerosis not treated by teriflunomid as a reference Number of treatment arms in the trial: 3
Phase:

Countries of recruitment
Austria	Canada	Germany	Russian Federation	Ukraine

Contacts

Name:
Address:
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Email:
Affiliation:

Name:
Address:
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Key inclusion & exclusion 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
• Women of childbearing potential without adequate contraception

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Multiple sclerosis
MedDRA version: 14.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: Teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-

Product Name: Teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-

Trade Name: Mutagrip
Product Name: Mutagrip
Pharmaceutical Form: Injection

Primary Outcome(s)

Primary end point(s): Number of patients achieving seroprotection (antibody titer =40)

Secondary Objective: - Assess the effect of teriflunomide on immunoglobulins,
- Assess the safety of influenza vaccination in multiple sclerosis (MS) patients treated with teriflunomide

Main Objective: Assess the antibody response to influenza vaccine in patients with relapsing form of multiple sclerosis (RMS) treated with teriflunomide and in a reference population of RMS patients

Timepoint(s) of evaluation of this end point: 28 days

Secondary Outcome(s)

Secondary end point(s): • Number of patients with an antibody titer increase of 2 fold or more
• Number of patients with an antibody titer increase of 4 fold or more
• Change of immunoglobulins (IgM, IgG, IgA) from baseline

Timepoint(s) of evaluation of this end point: 28 days

Secondary ID(s)

PDY11684

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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