{"doc_desc":{"title":"Tocilizumab sous-cutan\u00e9 en monoth\u00e9rapie ou en association avec des m\u00e9dicaments antirhumatismaux modificateurs de la maladie conventionnels de synth\u00e8se (csDMARD) chez des patients atteints de polyarthrite rhumato\u00efde active mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re, suivis par des rhumatologues en milieu hospitalier et en cabinet : \u00c9tude non interventionnelle visant \u00e0 d\u00e9crire, en conditions r\u00e9elles, le taux de r\u00e9tention du traitement bioth\u00e9rapeutique \u00e0 1 an","idno":"FRESH-PEF74116-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74116-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74116"},{"agency":"FReSH","code":"FRESH-PEF74116"},{"agency":"NCT","code":"NCT02608112"}]},"title":"Tocilizumab sous-cutan\u00e9 en monoth\u00e9rapie ou en association avec des m\u00e9dicaments antirhumatismaux modificateurs de la maladie conventionnels de synth\u00e8se (csDMARD) chez des patients atteints de polyarthrite rhumato\u00efde active mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re, suivis par des rhumatologues en milieu hospitalier et en cabinet : \u00c9tude non interventionnelle visant \u00e0 d\u00e9crire, en conditions r\u00e9elles, le taux de r\u00e9tention du traitement bioth\u00e9rapeutique \u00e0 1 an","alternate_title":"TANDEM"},"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 principal : \u00e9valuer le taux de r\u00e9tention du Tocilizumab sous-cutan\u00e9 \u00e0 12 mois dans des conditions r\u00e9elles chez des patients atteints de polyarthrite rhumato\u00efde active mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re suivis par des rhumatologues en milieu hospitalier ou en cabinet. Objectifs secondaires : - \u00c9valuer le taux de r\u00e9tention m\u00e9dicamenteuse de Tocilizumab sous-cutan\u00e9 \u00e0 6 et 18 mois. - Comparer la r\u00e9tention m\u00e9dicamenteuse de Tocilizumab sous-cutan\u00e9 en monoth\u00e9rapie et en association avec le Methotrexate ou un autre m\u00e9dicament antirhumatismal modificateur de la maladie conventionnel de synth\u00e8se (csDMARD). - D\u00e9crire le dosage des st\u00e9ro\u00efdes apr\u00e8s l'introduction de Tocilizumab sous-cutan\u00e9 avec une stratification sur l'utilisation du Methotrexate ou d'autres csDMARDs \u00e0 6, 12 et 18 mois. - \u00c9valuer l'observance du Tocilizumab sous-cutan\u00e9 en utilisant la version fran\u00e7aise du questionnaire d'observance en rhumatologie 5 (CQR5) et le journal du patient \u00e0 6, 12 et 18 mois. - \u00c9valuer la version fran\u00e7aise du CQR5 en \u00e9valuant la corr\u00e9lation avec les donn\u00e9es recueillies dans le journal du patient. - D\u00e9crire les modalit\u00e9s d'utilisation du Tocilizumab sous-cutan\u00e9. - D\u00e9crire la prise en charge de la polyarthrite rhumato\u00efde et le parcours de soins des patients entre les rhumatologues hospitaliers et les rhumatologues lib\u00e9raux. - D\u00e9crire l'efficacit\u00e9 de Tocilizumab sous-cutan\u00e9 dans les conditions r\u00e9elles d'utilisation. - D\u00e9crire les caract\u00e9ristiques des patients trait\u00e9s par Tocilizumab sous-cutan\u00e9 et les caract\u00e9ristiques des m\u00e9decins impliqu\u00e9s. - \u00c9valuer le profil de tol\u00e9rance de Tocilizumab sous-cutan\u00e9 dans les conditions r\u00e9elles d'utilisation. - D\u00e9crire la qualit\u00e9 de vie (QoL) des patients recevant Tocilizumab sous-cutan\u00e9 dans les conditions r\u00e9elles d'utilisation.","abstract":"","coll_dates":[{"start":"2015-01-01","end":"2018-01-01"}],"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 d'au moins 18 ans. - Patients atteints d'une polyarthrite rhumato\u00efde mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re n'ayant jamais \u00e9t\u00e9 trait\u00e9s par Tocilizumab (administr\u00e9 par voie intraveineuse ou en sous-cutan\u00e9) et pour lesquels les rhumatologues ont d\u00e9cid\u00e9 d'instaurer un traitement par Tocilizumab  sous-cutan\u00e9 en monoth\u00e9rapie ou en association avec un autre csDMARD. - Les patients qui ont \u00e9t\u00e9 inform\u00e9s verbalement et par \u00e9crit de cette \u00e9tude, qui ne s'opposent pas \u00e0 ce que leurs donn\u00e9es soient trait\u00e9es \u00e9lectroniquement ou soumises \u00e0 un contr\u00f4le de qualit\u00e9 et qui ont sign\u00e9 le formulaire de consentement.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"['SDISC']","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\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"286"},"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":"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":"eCRF","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Eligibilit\u00e9 \/ Formulaire de consentement ; Crit\u00e8res d'inclusion \/ Crit\u00e8res d'exclusion ; Statut ; D\u00e9mographie ; Ant\u00e9c\u00e9dents de polyarthrite rhumato\u00efde et ant\u00e9c\u00e9dents m\u00e9dicaux ; Traitements ant\u00e9rieurs ; Activit\u00e9 de la polyarthrite rhumato\u00efde : vitesse de s\u00e9dimentation des \u00e9rythrocytes (ESR) \/ prot\u00e9ine C-r\u00e9active (CRP) ; Traitement par RoActemra\u00ae sc ; Hospitalisation pour polyarthrite rhumato\u00efde ; Arr\u00eat pr\u00e9coce ; Traitement concomitant ; Effets ind\u00e9sirables ; CQR-5\/CQ5D\/HAQDI.","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"}