{"doc_desc":{"title":"\u00c9tude Pharmaco\u00c9pid\u00e9miologique de l'imPact du traitement par RoActemra\u00ae sur la fatigue des patientS atteints de polyarthrite rhumato\u00efde dans un contexte de vie r\u00e9elle","idno":"FRESH-PEF74130-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74130-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74130"},{"agency":"FReSH","code":"FRESH-PEF74130"},{"agency":"NCT","code":"NCT01185522"}]},"title":"\u00c9tude Pharmaco\u00c9pid\u00e9miologique de l'imPact du traitement par RoActemra\u00ae sur la fatigue des patientS atteints de polyarthrite rhumato\u00efde dans un contexte de vie r\u00e9elle","alternate_title":"PEPS"},"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 en situation r\u00e9elle l'\u00e9volution de la fatigue chez des patients atteints de polyarthrite rhumato\u00efde mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re au cours des 4 premiers mois de traitement par RoActemra\u00ae, ainsi que rechercher des facteurs pr\u00e9dictifs d'une am\u00e9lioration de ce sympt\u00f4me. Objectifs secondaires : - D\u00e9crire les caract\u00e9ristiques de base des patients et le niveau de fatigue ressenti \u00e0 l'inclusion par la population de patients trait\u00e9s par RoActemra\u00ae ; - Evaluer la corr\u00e9lation entre l'\u00e9volution de la fatigue \u00e9valu\u00e9e par le questionnaire FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy \u2013 Fatigue) et l'EVA fatigue (\u00c9chelle Visuelle Analogique de la Fatigue) au cours des 4 premiers mois de traitement par RoActemra\u00ae ; - \u00c9valuer le d\u00e9lai d'apparition de l'effet du RoActemra\u00ae sur la fatigue dans un contexte r\u00e9el ; - \u00c9valuer la corr\u00e9lation entre l'\u00e9volution de la fatigue et l'activit\u00e9 de la maladie au cours des 4 mois de traitement par RoActemra\u00ae ; - \u00c9valuer le PASS (Patient Acceptable Symptom State) des \u00e9chelles de fatigue (FACIT-Fatigue, EVA fatigue, SF36 vitalit\u00e9) apr\u00e8s 4 mois de traitement par RoActemra\u00ae ; - \u00c9valuer la corr\u00e9lation entre l'\u00e9volution de la fatigue et d'autres r\u00e9sultats rapport\u00e9s par les patients : douleur, qualit\u00e9 du sommeil, incapacit\u00e9, vitalit\u00e9 SF36, anxi\u00e9t\u00e9, d\u00e9pression ; - D\u00e9crire la prise en charge des patients atteints de polyarthrite rhumato\u00efde et trait\u00e9s par RoActemra\u00ae ; - D\u00e9crire tous les \u00e9v\u00e9nements ind\u00e9sirables survenus au cours de l'\u00e9tude.","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2011-01-01"}],"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 : - Homme ou femme \u00e2g\u00e9 de plus de 18 ans. - Patients pr\u00e9sentant une polyarthrite rhumato\u00efde mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re et pour lesquels un traitement par RoActemra\u00ae a \u00e9t\u00e9 planifi\u00e9 par l'investigateur ; - Patients d\u00e9sireux et capables de remplir, lors des consultations et \u00e0 domicile, les questionnaires de l'\u00e9tude visant \u00e0 \u00e9valuer l'impact de leur maladie et de leur traitement ; - Les patients qui ont re\u00e7u une information \u00e9crite et orale compl\u00e8te sur l'\u00e9tude et qui ont donn\u00e9 leur accord pour un futur traitement automatis\u00e9 des donn\u00e9es g\u00e9n\u00e9r\u00e9es au cours de l'\u00e9tude.  \",\n    \"clusion_E\": \"Patient pr\u00e9sentant une hypersensibilit\u00e9 connue au RoActemra\u00ae ou \u00e0 l'un des composants du m\u00e9dicament \u00e0 l'\u00e9tude ; - Patient pr\u00e9sentant une infection concomitante active ; - Patient participant actuellement \u00e0 un essai clinique visant \u00e0 \u00e9valuer un autre traitement de la polyarthrite rhumato\u00efde\"\n}","data_kind":"['Donn\u00e9es cliniques']","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\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\":\"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":"721"},"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":"07-07-2025","isContributorPI":false,"contributorName":"Camille BACHOT","contributorAffiliation":"F. HOFFMANN-LA ROCHE AG","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":"Caract\u00e9ristiques d\u00e9mographiques des patients - Ant\u00e9c\u00e9dents de polyarthrite rhumato\u00efde (PR) - Traitements concomitants - Nombre d\u2019articulations douloureuses et gonfl\u00e9es - Param\u00e8tres biologiques - Prise en charge de la polyarthrite rhumato\u00efde - \u00c9v\u00e9nements ind\u00e9sirables - FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy \u2013 Fatigue) - EVA Fatigue (\u00c9chelle Visuelle Analogique de la Fatigue) - EVA Douleur (\u00c9chelle Visuelle Analogique de la Douleur) - EVA Activit\u00e9 de la maladie (\u00c9chelle Visuelle Analogique de l\u2019Activit\u00e9 de la Maladie) - EVA Qualit\u00e9 du sommeil (\u00c9chelle Visuelle Analogique de la Qualit\u00e9 du Sommeil) - HAQ-DI (Health Assessment Questionnaire \u2013 Disability Index) - SF-36 Vitalit\u00e9 (Short Form-36 Vitalit\u00e9) - HADS (Hospital Anxiety and Depression Scale)","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"}