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English to French: A randomised, double-blind, placebo-controlled, multi-centre, phase II study of atacicept in anti-TNF naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate General field: Medical
Source text - English Purpose and aims of the study
Rheumatoid arthritis is a chronic inflammatory disease of the joints of unknown cause. Certain mechanisms that lead to joint inflammation (swelling and soreness) are becoming better understood and research in rheumatoid arthritis suggests that atacicept might play a role in controlling joint inflammation.
The goal of this research study is to evaluate the efficacy (effectiveness), tolerability and safety of atacicept in patients with active rheumatoid arthritis who have an inadequate response to other treatment(s), specifically methotrexate. In addition, the study will also measure the effects of atacicept on some parameters in the blood, (such as immune system proteins and antibodies) which reflect disease activity. This study will look at possible effects of atacicept on disease progression. This study will also compare treatment with atacicept to treatment with adalimumab (*****).
To be eligible you cannot have been treated with any tumor necrosis factor (TNF) blocking drugs.
It is also possible for you to participate in optional pharmacogenomic research whose purpose is to identify if there are genetic markers, (such as RA genes), which may help in predicting the response to treatment with atacicept. When used on a larger scale, this research could allow the development of new and more effective treatments for all patients who suffer from rheumatoid arthritis. If you wish to participate, you will be asked to sign a specific consent form for this optional research. Should you decide not to participate in the pharmacogenomic research, this decision will not affect your ability to take part in the main study.
About recombinant human atacicept
Atacicept is a protein produced in the laboratory by a process based on "recombinant DNA technology" (a technology which modifies the DNA sequence in order to produce a specific protein). Atacicept is expected to decrease inflammation by blocking the activity of two proteins (called BLyS and APRIL). Blocking these proteins and their actions on cells may play an important role in controlling the immune system and the inflammation related to your disease.
Atacicept is an investigational product of *****, the Sponsor of this study and is being developed in collaboration with *****. Atacicept is investigational, which means it is not approved by ***** for use outside of research studies like this one.
To date, approximately 177 subjects have already received atacicept at various dosages, some of which were much higher than the dosages being evaluated in this study.
Translation - French Objectifs de l’étude
La polyarthrite rhumatoïde (PR) est une maladie inflammatoire chronique des articulations, d’origine inconnue. Certains mécanismes conduisant à l’inflammation des articulations (gonflements et douleurs) sont aujourd’hui mieux compris et la recherche concernant la PR suggère que l’atacicept pourrait jouer un rôle dans le contrôle de l’inflammation des articulations.
Le but de cette étude est d’évaluer l’efficacité potentielle, la tolérabilité et l’innocuitéde l’atacicept chez les patients atteints de PR active et n’ayant pas bien répondu à d’autres traitements, en particulier au méthotrexate. De plus, cette étude mesure les effets de l’atacicept sur certains paramètres sanguins, comme les anticorps et protéines du système immunitaire, qui reflètent l’activité de la maladie. Cette étude s’intéresse aussi aux effets possibles de l’atacicept sur la progression de la maladie. Enfin, elle compare le traitement à l’atacicept au traitement à l’adalimumab (*****).
Pour pouvoir participer, vous devez ne pas avoir reçu de traitement aux inhibiteurs du facteur de nécrose tumorale (anti-TNF).
Il vous est également possible de participer à une recherche pharmacogénomique facultative dont le but est d’identifier s’il existe des marqueurs génétiques, par exemple des gènes de la PR, qui peuvent aider à prévoir la réponse à un traitement à base d’atacicept. Si elle est utilisée à plus grande échelle, cette étude pourrait permettre le développement de traitements nouveaux et plus efficaces pour tous les malades qui souffrent de PR. Si vous désirez participer, on vous demandera de remplir un formulaire spécifique de consentement pour cette étude facultative. Votre capacité à participer à l’étude principale ne sera pas compromise si vous décidez de ne pas participer à la recherche pharmacogénomique.
A propos de l’atacicept
L’atacicept est une protéine produite en laboratoire selon un procédé basé sur la « technologie de l’ADN recombinant » ; technologie qui modifie la séquence d’ADN afin de produire une protéine spécifique. On s’attend à ce que l’atacicept réduise l’inflammation en’inhibant l’activité de deux protéines, appelées BLyS et APRIL. Il est possible que le blocage de ces protéines et de leur action sur les cellules joue un rôle important dans la régulation du système immunitaire et de l’inflammation liée à votre maladie.
L’atacicept est un produit de recherche de *****, le promoteur de cette étude et est développé en collaboration avec *****. L’atacicept est expérimental, ce qui veut dire qu’il n’est pas approuvé par ***** pour un usage en dehors du cadre d’études comme celle-ci.
A ce jour, environ 177 personnes ont reçu de l’atacicept selon différentes posologies, dont certaines beaucoup plus élevées que celles évaluées dans cette étude.
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Other - New-York University
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Years of experience: 14. Registered at ProZ.com: May 2010.
Welcome to my profile!
I am a Frenchman born of a French mother and an Irish father. I have always loved practicing foreign languages and I have studied English, Dutch, Italian, Latin, Russian and Czech among others. I have also studied in the Netherlands, where I continue to live and where I have learned Dutch (Dutch as Foreign Language diploma). I am currently following an online course at New York University (NYU) in pursuit of a degree in General Translation.
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Keywords: English, French, Dutch, translation, translator, vertaler, vertaling, Nederlands, Nederland, Arabic. See more.English, French, Dutch, translation, translator, vertaler, vertaling, Nederlands, Nederland, Arabic, English, French Translator, All fields, French freelance translator, traducteur freelance Français, traduction juridique, law translation, Français, traduction medicale, traduction, French translation, political translation, general, English translation, economic, financial, Dutch translations, Dutch, French to English, English to French, Dutch to French, Dutch to English, Dutch translation services, journalism, economic translation, financial translation, medical translation, French freelancers, UN, United Nations, legal, economic Dutch translation services, accounting, Frans vertaler, Frans vertaling, Engels vertaling. See less.
