{"doc_desc":{"title":"\u00c9valuation des facteurs influen\u00e7ant l'utilisation de Roacterma\u00ae en monoth\u00e9rapie chez les patients atteints de polyarthrite rhumato\u00efde dans un contexte de vie r\u00e9elle","idno":"FRESH-PEF74117-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74117-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74117"},{"agency":"FReSH","code":"FRESH-PEF74117"},{"agency":"NCT","code":"NCT01474291"}]},"title":"\u00c9valuation des facteurs influen\u00e7ant l'utilisation de Roacterma\u00ae en monoth\u00e9rapie chez les patients atteints de polyarthrite rhumato\u00efde dans un contexte de vie r\u00e9elle","alternate_title":"ACTSOLO"},"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","lastname":"Medical data center","firstname":"","type":"contact","email":"data_sharing.france@roche.com","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 principal : D\u00e9crire dans un contexte r\u00e9el les facteurs influen\u00e7ant l'utilisation de RoActemra\u00ae en monoth\u00e9rapie ou en association avec des antirhumatismaux modificateurs de la maladie (DMARDs) chez des patients atteints de polyarthrite rhumato\u00efde. Objectifs secondaires : - D\u00e9crire les caract\u00e9ristiques des patients trait\u00e9s par RoActemra\u00ae en monoth\u00e9rapie ou en association avec un autre traitement. - D\u00e9crire l'impact des caract\u00e9ristiques des m\u00e9decins sur l'utilisation de RoActemra\u00ae en monoth\u00e9rapie ou en association. - Pour les patients trait\u00e9s par RoActemra\u00ae en monoth\u00e9rapie, d\u00e9crire les raisons de l'arr\u00eat ou de la non-utilisation des csDMARDs. - \u00c9valuer le maintien du traitement un an apr\u00e8s le d\u00e9but du traitement par RoActemra\u00ae dans un contexte de vie r\u00e9elle. - D\u00e9crire l'efficacit\u00e9 de RoActemra\u00ae dans des conditions r\u00e9elles d'utilisation. - D\u00e9crire l'effet du RoActemra\u00ae sur la qualit\u00e9 de vie dans des conditions r\u00e9elles d'utilisation. - \u00c9valuer le profil de s\u00e9curit\u00e9 du RoActemra\u00ae dans des conditions r\u00e9elles d'utilisation.","abstract":"","coll_dates":[{"start":"2013-01-01","end":"2014-01-01"}],"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 plus de 18 ans - Patient atteint de polyarthrite rhumato\u00efde, pour lequel le rhumatologue a d\u00e9cid\u00e9 de commencer le RoActemra\u00ae en association avec un csDMARD ou en monoth\u00e9rapie. - Patient ayant re\u00e7u des informations orales et \u00e9crites sur l'\u00e9tude, sans aucune objection quant \u00e0 l'utilisation de ses donn\u00e9es personnelles.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Bonnes pratiques cliniques\/Bonnes Pratiques de Pharmacovigilance (GCP\/GVP)']"}},"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 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\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"603"},"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":"17-01-2022","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"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":""},"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 ; Evaluation 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 ; Ev\u00e9nements ind\u00e9sirables ; Motif d'arr\u00eat pr\u00e9coce de l'\u00e9tude ; \u00c9chelle visuelle analogique (EVA) de la douleur, \u00c9chelle visuelle analogique (EVA) de la fatigue, et \u00e9valuation globale par le patient de l'activit\u00e9 de la maladie ; HAQ-DI, \u00e9chelle RAID (Rheumatoid Arthritis Impact of Disease), et PASS (Patient Acceptable Symptom State).","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"}