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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. |
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Register:
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EUCTR |
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Last refreshed on:
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30 April 2019 |
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Main ID: |
EUCTR2011-000215-79-FR |
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Date of registration:
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24/02/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA
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Scientific title:
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Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA |
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Date of first enrolment:
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07/06/2011 |
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Target sample size:
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30 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000215-79 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Pour être inclus dans l’étude les patients devront remplir les critères suivants :
Patients âgés de 18 à 85 ans.
Avoir une polyarthrite rhumatoïde nécessitant un traitement par Tociluzimab.
Affiliation à un régime de sécurité sociale.
Consentement éclairé écrit et capacité à se soumettre aux exigences de l’étude.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Si un seul de ces critères est rempli le patient ne sera pas inclus dans l’étude :
Patients sous tutelle ou curatelle.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Polyarthrite rhumatoïde
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Intervention(s)
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Trade Name: Roactemra
Pharmaceutical Form: Solution for injection
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
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Primary Outcome(s)
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Secondary Objective: Les objectifs secondaires seront de déterminer s’il existe une variation significative de la compliance artérielle, des paramètres du bilan lipidique et des marqueurs du risque cardiovasculaire (RAGE, MIF, ostéoprotégérine, NT-pro BNP) après 6 mois et un an de traitement.
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Primary end point(s): Le critère de jugement principal de l’étude sera la vasodilatation dépendante du débit (VDD) au niveau des artères périphériques (artère brachiale par Echographie Doppler).
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Main Objective: L’objectif principal sera de savoir s’il existe une amélioration significative de la fonction endothéliale après 6 mois de traitement par le Tocilizumab
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Secondary ID(s)
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RBHP 2010 Soubrier
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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