{"doc_desc":{"title":"Multicentric Cohort of Patients Receiving Systemic Treatment (Conventional or Biotherapy) for Moderate to Severe Cutaneous Psoriasis","idno":"FRESH-PEF8863-en","producers":[{"name":"SARRA POCHON","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8863-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8863"},{"agency":"FReSH","code":"FRESH-PEF8863"}]},"title":"Multicentric Cohort of Patients Receiving Systemic Treatment (Conventional or Biotherapy) for Moderate to Severe Cutaneous Psoriasis","alternate_title":"PSOBIOTEQ"},"study_authorization":{"agency":[]},"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":"Yes"},{"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":"Yes"}],"oth_id":[{"name":"The PSOBIOTEQ meets the objective of the European PSONET project to develop standardised procedures for the sharing and analysis of national data registers for the long-term monitoring of the efficacy and safety of systemic psoriasis treatment.","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"systemic conventional treatment"},{"keyword":"methotrexate"},{"keyword":"cyclosporine"},{"keyword":"health safety"},{"keyword":"real life"},{"keyword":"skin cancer"},{"keyword":"carcinoma"},{"keyword":"usage"},{"keyword":"biotherapy"},{"keyword":"infliximab"},{"keyword":"adalimumab"},{"keyword":"etanercept"},{"keyword":"ustekinumab"},{"keyword":"pharmacoepidemiology"},{"keyword":"exposure"},{"keyword":"melanoma"}],"topics":[{"topic":"Oncology","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":"Dermatology","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":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients receiving systemic treatment (biotherapy or conventional treatment) for moderate to severe cutaneous psoriasis. PSOBIOTEQ is the result of merging two studies that share the same study population but address different objectives: PSOBIO, developed by academic dermatologists and epidemiologists focusing on safety issues, and Pso-TEQ, developed by industrial teams at the request of the French Transparency Commission (Haute Autorit\u00e9 de Sant\u00e9) that focuses on usage issues. The exposure of interest is the biological therapy exposure: Infliximab, Adalimumab, Etanercept and Ustekinumab. The general objective of PSOBIO is to assess the safety and efficacy of biotherapy in the treatment of cutaneous psoriasis \"in real life\" compared with conventional systemic therapy. However, Pso-TEQ has a descriptive objective concerning the usage methods of biological therapies \"in real life\" and the long-term benefits.","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Inclusion criteria: - Patients aged 18 or over; - Attending or hospitalised in services participating in the study; - Has been informed of the research objectives and outcome and has signed an informed consent form to participate; - Cutaneous psoriasis (clinical diagnosis); - Justifying the prescription of major systemic therapy (Methotrexate or Cyclosporine or biotherapy) and belongs to one of the following 3 groups: - Patients beginning biotherapy (Infliximab, Adalimumab, Etanercept, Ustekinumab and other biotherapy entering the market) AND who have not been previously exposed; - Patients beginning biotherapy AND who have been already exposed. \",\n    \"clusion_E\": \"biotherapy) for at least 3 months (Methotrexate or Cyclosporine) AND for which no biotherapy treatment is planned within the next 6 months AND are naive to all biotherapy.criteria: - Patients for whom cutaneous psoriasis is not the main reason for systemic treatment (biotherapy or conventional treatment); treatment justified by psoriatic arthritis, concomitant Crohn's disease, etc. - Patients unable to comply with the cohort monitoring (unreachable by phone, unable to complete the self -administered questionnaire) or whose follow-up is expected to be difficult.\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data','Behavioral data']","quality_statement":{"standards":[{"name":"['MeDRA']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"2,636"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Data belongs to AP-HP and cannot be used or sent to a third party without prior consent. Access to data is by request to the Psobioteq project scientific committee; Access shall also be subject to a partnership contract signed between AP-HP and the legal representative of the requesting team specifying the terms and conditions of data provision. Every laboratory participating in the Psobioteq study will have access to data involving their product.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"Psonet study variables (European study) will be sent to the European registry according to the terms outlined in a specific document."}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"12-05-2014","lastUpdatedAuto":null,"lastUpdatedManual":"13-05-2015","isContributorPI":"No","contributorName":"SARRA POCHON","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry","Public (France)","Public (France)","Industry","Public (France)","Industry","Industry"],"otherFundingAgentType":["","","","","","",""]},"sponsor":{"sponsorType":["Private non-profit","Public (France)","Industry","Industry","Industry","Industry"],"otherSponsorType":["","","","","",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Collection of clinical and paraclinical data within the cohort will be carried out using a CleanWEB Electronic Case Report Form. An adjudication committee shall validate the potential SAEs and significant medical effects presented to them. The events requiring adjudication will be listed by the Scientific Committee for the study. Events to be adjudicated will be sent to experts through anonymised data transfer by CRA under the coordination of the project head. Adjudication will be applied to treatment received (biotherapy or not), based on clinical history and to possible photographs and additional adapted tests.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Metropolitan France"},"dataTypes":{"clinicalDataDetails":"--","biologicalDataDetails":"--","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}