{"doc_desc":{"title":"Cohorte multicentrique de patients recevant un traitement syst\u00e9mique (conventionnel ou bioth\u00e9rapie) pour un psoriasis cutan\u00e9 mod\u00e9r\u00e9 \u00e0 s\u00e9v\u00e8re","idno":"FRESH-PEF8863-fr","producers":[{"name":"SARRA POCHON","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8863-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8863"},{"agency":"FReSH","code":"FRESH-PEF8863"}]},"title":"Cohorte multicentrique de patients recevant un traitement syst\u00e9mique (conventionnel ou bioth\u00e9rapie) pour un psoriasis cutan\u00e9 mod\u00e9r\u00e9 \u00e0 s\u00e9v\u00e8re","alternate_title":"PSOBIOTEQ"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Olivier;CHOSIDOW","PILabo":"AP-HP \/ Service de DermatologieH\u00f4pital Henri Mondor","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-8400-4310","role":"pi id"},{"title":"IdRef","uri":"02881441X","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"olivier.chosidow@aphp.fr","isContact":"Oui"},{"type":"investigator","name":"Florence;TUBACH","PILabo":"AP-HP \/ D\u00e9partement d'Epid\u00e9miologie et Recherche CliniqueURC- Paris Nord INSERM CIC-EC 1425H\u00f4pital Bichat","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-3590-4638","role":"pi id"},{"title":"IdRef","uri":"06974114X","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"florence.tubach@aphp.fr","isContact":"Oui"}],"oth_id":[{"name":"La cohorte PSOBIOTEQ r\u00e9pond \u00e0 l\u2019objectif du projet europ\u00e9en PSONET qui est le d\u00e9veloppement de proc\u00e9dures standardis\u00e9es pour la mise en commun et l\u2019analyse des donn\u00e9es de registres nationaux sur le suivi \u00e0 long terme de l\u2019efficacit\u00e9 et la s\u00e9curit\u00e9 d\u2019emploi des traitements syst\u00e9miques du psoriasis.","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"SOCIETE FRAN\u00c7AISE DE DERMATOLOGIE ET DE PATHOLOGIE SEXUELLEMENT TRANSMISSIBLE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03gck1m55","role":"sponsor id"}],"role":"sponsor"},{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"},{"name":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12","role":"sponsor id"},{"title":"SIREN","uri":"417890589","role":"sponsor id"}],"role":"sponsor"},{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10","role":"sponsor id"},{"title":"SIREN","uri":"433623550","role":"sponsor id"}],"role":"sponsor"},{"name":"JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE)","extlink":[{"title":"SIREN","uri":"562033068","role":"sponsor id"}],"role":"sponsor"},{"name":"ABBVIE","extlink":[{"title":"SIREN","uri":"750775660","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ABBOTT FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05wz8pk64"},{"title":"SIREN","uri":"602950206"}]},{"name":"AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01g80gk13"},{"title":"SIREN","uri":"180036113"}]},{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14"},{"title":"SIREN","uri":"267500452"}]},{"name":"JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE)","extlink":[{"title":"SIREN","uri":"562033068"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12"},{"title":"SIREN","uri":"417890589"}]},{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]}]},"distribution_statement":{"contact":[{"name":"Olivier;CHOSIDOW","email":"olivier.chosidow@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Florence;TUBACH","email":"florence.tubach@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Traitement syst\u00e9mique conventionnel"},{"keyword":"bioth\u00e9rapie"},{"keyword":"m\u00e9thotrexte"},{"keyword":"ciclosporine"},{"keyword":"infliximab"},{"keyword":"adalimumab"},{"keyword":"etanercept"},{"keyword":"ustekinumab"},{"keyword":"s\u00e9curit\u00e9 sanitaire"},{"keyword":"en vie r\u00e9elle"},{"keyword":"pharmaco\u00e9pid\u00e9miologie"},{"keyword":"cancer cutan\u00e9"},{"keyword":"carcinome"},{"keyword":"exposition"},{"keyword":"utilisation"},{"keyword":"m\u00e9lanome"}],"topics":[{"topic":"Oncologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"topic":"Dermatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5375c411-6db9-40ed-a854-6554102a587b"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D003880"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"PSOBIOTEQ est une cohorte prospective multicentrique incluant des patients recevant un traitement syst\u00e9mique (bioth\u00e9rapie ou traitements de fond conventionnels) pour un psoriasis cutan\u00e9 mod\u00e9r\u00e9 \u00e0 s\u00e9v\u00e8re. PSOBIOTEQ est le r\u00e9sultat de la fusion de deux \u00e9tudes partageant la m\u00eame population d'\u00e9tude mais d'objectifs diff\u00e9rents : PSOBIO, d\u00e9velopp\u00e9e par des dermatologues et \u00e9pid\u00e9miologistes acad\u00e9miques se focalisant sur les enjeux de s\u00e9curit\u00e9, et Pso-TEQ d\u00e9velopp\u00e9e par des industriels \u00e0 la demande de la Commission de transparence \/\/ Haute Autorit\u00e9 de Sant\u00e9, et se focalisant sur des enjeux d'utilisation. L'exposition d'int\u00e9r\u00eat est l'exposition \u00e0 une th\u00e9rapie biologique: infliximab, adalimumab, etanercept, ustekinumab. L'objectif g\u00e9n\u00e9ral de PSOBIO est d'\u00e9valuer \"en vie r\u00e9elle\" la s\u00e9curit\u00e9 et l'efficacit\u00e9 des bioth\u00e9rapies dans le traitement du psoriasis cutan\u00e9e en comparaison avec les th\u00e9rapies syst\u00e9miques conventionnelles. Par ailleurs, Pso-TEQ a un objectif descriptif concernant les modalit\u00e9s d'utilisation des bioth\u00e9rapies en situation r\u00e9elle et leurs b\u00e9n\u00e9fices \u00e0 long-terme.","abstract":"","coll_dates":[{"start":"2012-01-01","end":"2020-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d'inclusion: - Patient \u00e2g\u00e9 de 18 ans ou plus ; - consultant ou hospitalis\u00e9 dans des services participant \u00e0 l\u2019\u00e9tude ; - ayant \u00e9t\u00e9 inform\u00e9 sur les objectifs et le d\u00e9roulement de la recherche et ayant sign\u00e9 un formulaire de consentement \u00e9clair\u00e9 et \u00e9crit \u00e0 y participer ; - pour un psoriasis cutan\u00e9 (diagnostic clinique) ; - justifiant un traitement syst\u00e9mique majeur (le m\u00e9thotrexate ou la ciclosporine ou une bioth\u00e9rapie et correspondant \u00e0 l\u2019une des 3 situations suivantes :          - Patient pour lequel est initi\u00e9e une bioth\u00e9rapie (infliximab, adalimumab, etanercept, ustekinumab et toute autre bioth\u00e9rapie arrivant sur le march\u00e9) ET n'en ayant jamais re\u00e7u pr\u00e9c\u00e9demment          - Patient pour lequel est initi\u00e9e une bioth\u00e9rapie, ET en ayant d\u00e9j\u00e0 re\u00e7u.         - Patient recevant un traitement syst\u00e9mique conventionnel majeur (hors bioth\u00e9rapie) depuis au moins trois mois (m\u00e9thotrexate ou ciclosporine) ET pour lequel il n'est pas pr\u00e9vu d'instituer un traitement par bioth\u00e9rapie dans les 6 prochains mois ET na\u00eff de toute bioth\u00e9rapie.  \",\n    \"clusion_E\": \"Patient pour qui le psoriasis cutan\u00e9 n'est pas le motif principal de traitement syst\u00e9mique (bioth\u00e9rapie ou traitement conventionnel) ; traitement justifi\u00e9 par un rhumatisme psoriasique, une maladie de Crohn concomitante  - Patient dans l'incapacit\u00e9 \u00e0 se plier aux modalit\u00e9s de suivi de la cohorte (non joignable par t\u00e9l\u00e9phone, incapable de compl\u00e9ter l'auto-questionnaire), dont le suivi est jug\u00e9 difficile\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es comportementales']","quality_statement":{"standards":[{"name":"['MeDRA']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"2 636"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"L\u2019AP-HP est propri\u00e9taire des donn\u00e9es et aucune utilisation ou transmission \u00e0 un tiers ne peut \u00eatre effectu\u00e9e sans son accord pr\u00e9alable. L\u2019acc\u00e8s aux donn\u00e9es, fait l\u2019objet d\u2019une demande aupr\u00e8s du comit\u00e9 scientifique du projet Psobioteq; Cet acc\u00e8s sera \u00e9galement conditionn\u00e9 \u00e0 la mise en place d\u2019un contrat de partenariat sign\u00e9 entre l\u2019AP-HP et le repr\u00e9sentant l\u00e9gal de l\u2019\u00e9quipe demanderesse pr\u00e9cisant les modalit\u00e9s et conditions de mise \u00e0 disposition des donn\u00e9es. Chaque laboratoire participant \u00e0 l\u2019\u00e9tude Psobioteq aura acc\u00e8s aux donn\u00e9es concernant son produit.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"Les variables de l\u2019\u00e9tude Psonet (\u00e9tude europ\u00e9enne) seront transmises au registre europ\u00e9en selon des modalit\u00e9s qui seront d\u00e9crites dans un document sp\u00e9cifique."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"12-05-2014","lastUpdatedAuto":null,"lastUpdatedManual":"13-05-2015","isContributorPI":"Non","contributorName":"SARRA POCHON","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie","Public (France)","Public (France)","Industrie","Public (France)","Industrie","Industrie"],"otherFundingAgentType":["","","","","","",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif","Public (France)","Industrie","Industrie","Industrie","Industrie"],"otherSponsorType":["","","","","",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Le recueil des donn\u00e9es cliniques et para cliniques dans le cadre de la cohorte, se fera \u00e0 l'aide d\u2019un Cahier d'Observations Electronique CleanWEB. Un comit\u00e9 d\u2019adjudication a pour mission de valider les potentiels EIG et les effets m\u00e9dicalement significatifs qui leur sont pr\u00e9sent\u00e9s. Les \u00e9v\u00e8nements n\u00e9cessitant adjudications seront list\u00e9s par le comit\u00e9 scientifique de l\u2019\u00e9tude.Les \u00e9v\u00e8nements \u00e0 adjudiquer seront soumis aux experts gr\u00e2ce \u00e0 un transfert de donn\u00e9es anonymis\u00e9es par les ARC sous la coordination du chef de projet. L\u2019adjudication se fera en insu du traitement re\u00e7u (bioth\u00e9rapie ou non), sur la base de l\u2019histoire clinique et \u00e9galement des \u00e9ventuelles photographies et examens compl\u00e9mentaires adapt\u00e9s.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"--","biologicalDataDetails":"--","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}