{"doc_desc":{"title":"Etude des conditions d'utilisation de Golimumab et de son impact, en PRATIque CourantE, chez les patients atteints d'un rhumatisme inflammatoire chronique.","idno":"FRESH-PEF73342-fr","producers":[{"name":"Laurie LEVY-BACHELOT","affiliation":"MSD FRANCE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73342-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73342"},{"agency":"FReSH","code":"FRESH-PEF73342"}]},"title":"Etude des conditions d'utilisation de Golimumab et de son impact, en PRATIque CourantE, chez les patients atteints d'un rhumatisme inflammatoire chronique.","alternate_title":"GO-PRACTICE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Najat;GOUYETTE","firstname":"Najat","lastname":"GOUYETTE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12","role":"organisation id"},{"title":"SIREN","uri":"417890589","role":"organisation id"}],"email":"","affiliationName":"MSD FRANCE","PILabo":"MSD France","isContact":false},{"name":"Laurie;LEVY-BACHELOT","firstname":"Laurie","lastname":"LEVY-BACHELOT","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12","role":"organisation id"},{"title":"SIREN","uri":"417890589","role":"organisation id"}],"email":"laurie.levy-bachelot@msd.com","affiliationName":"MSD FRANCE","PILabo":"MSD France","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12","role":"sponsor id"},{"title":"SIREN","uri":"417890589","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12"},{"title":"SIREN","uri":"417890589"}]}]},"distribution_statement":{"contact":[{"name":"Laurie;LEVY-BACHELOT","lastname":"LEVY-BACHELOT","firstname":"Laurie","type":"contact","email":"laurie.levy-bachelot@msd.com","affiliationName":"MSD FRANCE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00kt5kp12","role":"organisation id","title":"ROR"},{"uri":"417890589","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[],"topics":[{"topic":"Rhumatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bfb0bafd-7894-45ba-84fc-ddab5fd6c537"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D012219"}]},{"topic":"Arthropathies inflammatoires","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/396939646","title":"CIM-11"}]}],"purpose":"Evaluer le maintien du traitement par golimumab 24 mois apr\u00e8s la prescription initiale chez des patients adultes atteints d'un rhumatisme inflammatoire chronique, en pratique clinique en France Le crit\u00e8re principal est le pourcentage total de patients ayant maintenu le traitement par golimumab deux ans apr\u00e8s la prescription initiale.","abstract":"","coll_dates":[{"start":"","end":""}],"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\": \"Inclusion :  1. Patients \u00e2g\u00e9s de 18 ans ou plus.  2. Patients ayant donn\u00e9 leur consentement oral pour participer apr\u00e8s avoir re\u00e7u des informations orales et \u00e9crites \u00e0 propos de l'\u00e9tude.  3. Patients ayant un diagnostic de rhumatisme inflammatoire chronique.  4. Patients ayant une prescription initiale hospitali\u00e8re de golimumab mais n'ayant pas encore initi\u00e9 le traitement par golimumab. 5. Patients capables de comprendre et remplir les questionnaires d'auto-\u00e9valuation  \",\n    \"clusion_E\": \"1 Patients trait\u00e9s ant\u00e9rieurement par golimumab et ayant arr\u00eat\u00e9 le traitement avant l'inclusion  2 patients ayant particip\u00e9 \u00e0 des \u00e9tudes pr\u00e9c\u00e9dentes du golimumab 3 Patients ayant d\u00e9j\u00e0 commenc\u00e9 le traitement par golimumab avant l'inclusion et \u00e9tant sous traitement au moment de l'inclusion  4 Patients pr\u00e9sentant des pathologies ou conditions qui, selon l'investigateur, limiteraient la capacit\u00e9 du patient \u00e0 participer totalement \u00e0 l'\u00e9tude ou \u00e0 respecter tous les imp\u00e9ratifs de l'\u00e9tude;\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Pas d\u2019acc\u00e8s","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"750 inclus"},"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\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"18-07-2016","lastUpdatedAuto":null,"lastUpdatedManual":"07-09-2020","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Pas de d\u00e9tails"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}