{"doc_desc":{"title":"Description en vie r\u00e9elle de l'\u00e9pargne glucocortico\u00efde chez les patients trait\u00e9s par RoActemra\u00ae pour une polyarthrite rhumato\u00efde mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re","idno":"FRESH-PEF74129-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74129-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74129"},{"agency":"FReSH","code":"FRESH-PEF74129"},{"agency":"NCT","code":"NCT01392001"}]},"title":"Description en vie r\u00e9elle de l'\u00e9pargne glucocortico\u00efde chez les patients trait\u00e9s par RoActemra\u00ae pour une polyarthrite rhumato\u00efde mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re","alternate_title":"SPARE-1"},"study_authorization":{"agency":[{"name":"Autre"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":";Medical data center","email":"data_sharing.france@roche.com","type":"contact","affiliationName":"F. HOFFMANN-LA ROCHE AG","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01mqmer16","role":"organisation id","title":"ROR"},{"uri":"775752140","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Tocilizumab"}],"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"}]},{"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":"Objectif primaire : D\u00e9crire en vie r\u00e9elle l'effet d'\u00e9pargne glucocortico\u00efde apr\u00e8s 12 mois de traitement par RoActemra\u00ae chez des patients atteints de PR mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re et d\u00e9terminer les facteurs pr\u00e9dictifs. Objectifs secondaires : 1. d\u00e9crire les caract\u00e9ristiques de la population au d\u00e9but de l'\u00e9tude ; 2. \u00e9valuer l'efficacit\u00e9 du RoActemra\u00ae (r\u00e9ponse EULAR et\/ou dosage des glucocortico\u00efdes) en vie r\u00e9elle ; 3. d\u00e9crire la prise en charge th\u00e9rapeutique de la polyarthrite rhumato\u00efde [glucocortico\u00efdes et\/ou antirhumatismaux modificateurs de la maladie (ARMM) conventionnels en association avec le RoActemra\u00ae] ; 4. d\u00e9crire l'\u00e9volution de la capacit\u00e9 fonctionnelle des patients et l'impact de la maladie sur le patient au cours du suivi (questionnaires d'auto-\u00e9valuation HAQ-DI et RAID) ; 5. \u00e9valuer la s\u00e9curit\u00e9 du RoActemra\u00ae.","abstract":"","coll_dates":[{"start":"2011-01-01","end":"2013-01-01"}],"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 : - Patients \u00e2g\u00e9s de 18 ans et plus ; - Patients atteints de polyarthrite rhumato\u00efde mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re ; - Patients pour lesquels le rhumatologue a d\u00e9cid\u00e9 d'initier un traitement par RoActemra\u00ae ; - Patients prenant des glucocortico\u00efdes oraux >5 mg\\\/jour de prednisone ou \u00e9quivalent depuis au moins 3 mois ; - Les patients ayant re\u00e7u des informations orales et \u00e9crites sur l'\u00e9tude et n'ayant pas soulev\u00e9 d'objection \u00e0 la collecte et au traitement informatique de leurs donn\u00e9es personnelles.  \",\n    \"clusion_E\": \"Les patients participant \u00e0 un essai clinique sur la polyarthrite rhumato\u00efde au moment de l'inclusion ne pouvaient pas participer \u00e0 l'\u00e9tude\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"['CDISC']","committee":"","governance":""}],"other_quality_statement":"['Bonnes pratiques cliniques\/Bonnes Pratiques de Pharmacovigilance (GCP\/GVP)']"}},"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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"321"},"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":"","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":"23-06-2022","lastUpdatedAuto":null,"lastUpdatedManual":"13-01-2025","isContributorPI":"Non","contributorName":"Camille BACHOT","contributorAffiliation":"F. HOFFMANN-LA ROCHE AG","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":""},"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":"papier","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Validation des crit\u00e8res d'inclusion et d'exclusion - Donn\u00e9es sociod\u00e9mographiques - Ant\u00e9c\u00e9dents m\u00e9dicaux et maladies concomitantes - Ant\u00e9c\u00e9dents de polyarthrite rhumato\u00efde, traitements ant\u00e9rieurs et\/ou en cours - Donn\u00e9es cliniques et biologiques les plus r\u00e9centes - \u00c9valuation globale par le m\u00e9decin de l'activit\u00e9 de la polyarthrite rhumato\u00efde (asymptomatique \u00e0 tr\u00e8s s\u00e9v\u00e8re) - Traitements de la polyarthrite rhumato\u00efde et motif d'arr\u00eat le cas \u00e9ch\u00e9ant - Traitement par RoActemra\u00ae - \u00c9v\u00e9nements ind\u00e9sirables - Motif d'arr\u00eat pr\u00e9coce de l'\u00e9tude - HAQ-DI, \u00e9chelle RAID.","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"}