[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100286048":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":37,"armGroups":38,"interventions":44,"overallOfficials":49,"centralContacts":53,"locations":63,"responsibleParty":213,"collaborators":215,"id":219,"slug":33,"hasResults":220,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":220,"sex":225,"minAge":226,"maxAge":33,"enrollmentInfo":227,"targetDuration":33,"studyType":230,"phases":33,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":83,"whyStopped":33,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of anti-Ro\u002FSSA IgE positive patients","Comparison of proportion of anti-Ro\u002FSSA IgE positive patients between patients with active pSS and patient without active pSS anti-Ro\u002FSSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).\n\nActive pSS is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI) ≥ 5","Day 1",[14,17,20,24,27,30],{"measure":15,"description":16,"timeFrame":12},"Correlation between anti-Ro\u002FSSA IgE titers and pSS's activity.","pSS's activity is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI).\n\nAnti-Ro\u002FSSA IgE titers is measured by serial dilutions of the serum. Anti-Ro\u002FSSA IgE titers is the last dilution whose absorbance (in optical density) is higher than positivity threshold.",{"measure":18,"description":19,"timeFrame":12},"Correlation between anti-Ro\u002FSSA IgE positive patients and the symptomatology level","Anti-Ro\u002FSSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).\n\nThe symptomatology level is measured by the Score Eular Sjogren's Syndrome Patient Reported Index (ESSPRI).\n\nIf ESSPRI≥5: symptomatology whose intensity felt by the patient is not acceptable.\n\nIf ESSPRI\\\u003C5: symptomatology whose intensity felt by the patient is acceptable.",{"measure":21,"description":22,"timeFrame":23},"Correlation between anti-Ro\u002FSSA IgE positive patients and onset of lymphoma","Anti-Ro\u002FSSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).\n\nThere is a medical monitoring every years by medical record and\u002For by phone know that a development of lymphoma.","5 years",{"measure":25,"description":26,"timeFrame":12},"Correlation between anti-Ro\u002FSSA IgE positive patients and interferon alpha signature","Anti-Ro\u002FSSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).\n\nInterferon alpha signature level is measured by real-time Polymerase Chain Reaction (PCR). They calculate the average of delta cycle threshold in messenger ribonucleic acid (mRNA) of regulate gene by interferon alpha.",{"measure":28,"description":29,"timeFrame":12},"Comparison between anti-Ro\u002FSSA IgE positive patients and clinical and biologic characteristics","Anti-Ro\u002FSSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).\n\nComposite outcome of clinical and biologic characteristics is describe below.\n\nClinical characteristics: type of affected organs, lymphoma medical history, allergic disorders, scores Eular Sjögren Syndrome Disease Activity Index (ESSDAI), Eular Sjogren's Syndrome Patient Reported Index (ESSPRI) and analogue visual scale disease patient and doctor, saliva flow and Schirmer test.\n\nBiologic characteristics: anti-Ro\u002FSSA IgE titers, rheumatoid factor titers and number of totals lymphocytes and T cluster of differentiation 4 (CD4) lymphocytes.",{"measure":31,"description":32,"timeFrame":12},"Comparison between anti-La\u002FSSB IgE positive patients and clinical and biologic characteristics","Anti-La\u002FSSB IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).\n\nComposite outcome of clinical and biologic characteristics is describe below.\n\nClinical characteristics: type of affected organs, lymphoma medical history, allergic disorders, scores Eular Sjögren Syndrome Disease Activity Index (ESSDAI), Eular Sjogren's Syndrome Patient Reported Index (ESSPRI) and analogue visual scale disease patient and doctor, saliva flow and Schirmer test.\n\nBiologic characteristics: anti-La\u002FSSB IgE titers, rheumatoid factor titers and number of totals lymphocytes and T CD4 lymphocytes.",null,{"allocation":33,"interventionModel":33,"interventionModelDescription":33,"primaryPurpose":33,"observationalModel":35,"timePerspective":36,"maskingInfo":33},"COHORT","PROSPECTIVE","Patients with primary Sjögren's syndrome",[39],{"label":40,"type":33,"description":41,"interventionNames":42},"patients with primary Sjögren's syndrome","Blood samples will be collected at inclusion to determine anti-Ro\u002FSSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA) in patients with primary Sjögren's syndrome according to the American-European Consensus Criteria.",[43],"Other: Blood samples",[45],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":33},"Blood samples","Blood samples will be collected at inclusion to determine anti-Ro\u002FSSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA).",[40],[50],{"name":51,"affiliation":5,"role":52},"Pascal CATHEBRAS, MD PhD","PRINCIPAL_INVESTIGATOR",[54,59],{"name":51,"role":55,"phone":56,"phoneExt":57,"email":58},"CONTACT","(0)477828342","+33","pascal.cathebras@chu-st-etienne.fr",{"name":60,"role":55,"phone":61,"phoneExt":57,"email":62},"Florence RANCON, CRA","(0)477120284","florence.rancon@chu-st-etienne.fr",[64,81,100,122,143,159,170,181],{"facility":65,"status":66,"city":67,"state":33,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"CH Pierre Oudot","NOT_YET_RECRUITING","Bourgoin","38300","France","FR",{"type":72,"coordinates":73},"Point",[74,75],5.27236,45.59889,{"lat":75,"lon":74},[78,80],{"name":79,"role":55,"phone":33,"phoneExt":33,"email":33},"Marielle ROUX, MD",{"name":79,"role":52,"phone":33,"phoneExt":33,"email":33},{"facility":82,"status":83,"city":84,"state":33,"zip":85,"country":69,"countryCode":70,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"CHU Estaing - Clermont Ferrand","RECRUITING","Clermont-Ferrand","63000",{"type":72,"coordinates":87},[88,89],3.08682,45.77969,{"lat":89,"lon":88},[92,94,95,98],{"name":93,"role":55,"phone":33,"phoneExt":33,"email":33},"Marc RUIVARD, MD PhD",{"name":93,"role":52,"phone":33,"phoneExt":33,"email":33},{"name":96,"role":97,"phone":33,"phoneExt":33,"email":33},"Virginie RIEU, MD","SUB_INVESTIGATOR",{"name":99,"role":97,"phone":33,"phoneExt":33,"email":33},"Vincent GROBOST, MD",{"facility":101,"status":83,"city":102,"state":33,"zip":103,"country":69,"countryCode":70,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"CHU Grenoble Alpes","Grenoble","38700",{"type":72,"coordinates":105},[106,107],5.71479,45.17869,{"lat":107,"lon":106},[110,112,114,116,118,120],{"name":111,"role":55,"phone":33,"phoneExt":33,"email":33},"Laurence BOULLET, MD PhD",{"name":113,"role":52,"phone":33,"phoneExt":33,"email":33},"Laurence BOUILLET, MD PhD",{"name":115,"role":97,"phone":33,"phoneExt":33,"email":33},"Françoise SARROT-REYNAULD, MD",{"name":117,"role":97,"phone":33,"phoneExt":33,"email":33},"Alban DEROUX, MD",{"name":119,"role":97,"phone":33,"phoneExt":33,"email":33},"Alexis BOCQUET, MD",{"name":121,"role":97,"phone":33,"phoneExt":33,"email":33},"Aurélie MADELON, MD",{"facility":123,"status":83,"city":124,"state":33,"zip":125,"country":69,"countryCode":70,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Hôpital de la Croix Rousse","Lyon","69317",{"type":72,"coordinates":127},[128,129],4.84789,45.74906,{"lat":129,"lon":128},[132,134,135,137,139,141],{"name":133,"role":55,"phone":33,"phoneExt":33,"email":33},"Pascal SEVE, MD",{"name":133,"role":52,"phone":33,"phoneExt":33,"email":33},{"name":136,"role":97,"phone":33,"phoneExt":33,"email":33},"Yvan JAMILLOUX, MD",{"name":138,"role":97,"phone":33,"phoneExt":33,"email":33},"Mathieu GERFAUD-VALENTIN, MD",{"name":140,"role":97,"phone":33,"phoneExt":33,"email":33},"Claire BERNARD, MD",{"name":142,"role":97,"phone":33,"phoneExt":33,"email":33},"Mathilde FRANÇOIS, MD",{"facility":144,"status":83,"city":124,"state":33,"zip":145,"country":69,"countryCode":70,"cosmosGeoPoint":146,"geoPoint":148,"contacts":149},"CH Lyon Sud","69495",{"type":72,"coordinates":147},[128,129],{"lat":129,"lon":128},[150,152,153,155,157],{"name":151,"role":55,"phone":33,"phoneExt":33,"email":33},"Jean-Christophe LEGA, MD",{"name":151,"role":52,"phone":33,"phoneExt":33,"email":33},{"name":154,"role":97,"phone":33,"phoneExt":33,"email":33},"Quitterie REYNAUD, MD",{"name":156,"role":97,"phone":33,"phoneExt":33,"email":33},"Isabelle DURIEU, MD",{"name":158,"role":97,"phone":33,"phoneExt":33,"email":33},"Sabine MAINBOURG, MD",{"facility":160,"status":66,"city":124,"state":33,"zip":33,"country":69,"countryCode":70,"cosmosGeoPoint":161,"geoPoint":163,"contacts":164},"Hôpital Edouard Herriot - CHU Lyon",{"type":72,"coordinates":162},[128,129],{"lat":129,"lon":128},[165,167,168],{"name":166,"role":55,"phone":33,"phoneExt":33,"email":33},"Arnaud HOT, MD PhD",{"name":166,"role":52,"phone":33,"phoneExt":33,"email":33},{"name":169,"role":97,"phone":33,"phoneExt":33,"email":33},"Cécile-Audrey DUREL, MD",{"facility":171,"status":66,"city":172,"state":33,"zip":33,"country":69,"countryCode":70,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"CHU Reims","Reims",{"type":72,"coordinates":174},[175,176],4.02853,49.26526,{"lat":176,"lon":175},[179],{"name":180,"role":97,"phone":33,"phoneExt":33,"email":33},"Amélie SERVATTAZ, MD PhD",{"facility":182,"status":83,"city":183,"state":33,"zip":184,"country":69,"countryCode":70,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Chu Saint-Etienne","Saint-Etienne","42055",{"type":72,"coordinates":186},[187,188],4.39,45.43389,{"lat":188,"lon":187},[191,192,193,195,197,199,201,203,205,207,209,211],{"name":51,"role":55,"phone":33,"phoneExt":33,"email":33},{"name":51,"role":52,"phone":33,"phoneExt":33,"email":33},{"name":194,"role":97,"phone":33,"phoneExt":33,"email":33},"Isabelle GUICHARD, MD",{"name":196,"role":97,"phone":33,"phoneExt":33,"email":33},"Jean-Baptiste GAULTIER, MD",{"name":198,"role":97,"phone":33,"phoneExt":33,"email":33},"Anne-Emmanuelle DEPINCE-BERGER, MD",{"name":200,"role":97,"phone":33,"phoneExt":33,"email":33},"Thierry THOMAS, MD PhD",{"name":202,"role":97,"phone":33,"phoneExt":33,"email":33},"Hubert MAROTTE, MD PhD",{"name":204,"role":97,"phone":33,"phoneExt":33,"email":33},"Héloïse MUNOZ-PONS, MD",{"name":206,"role":97,"phone":33,"phoneExt":33,"email":33},"Martin KILLIAN, MD",{"name":208,"role":97,"phone":33,"phoneExt":33,"email":33},"Béatrice PALLOT-PRADES, MD",{"name":210,"role":97,"phone":33,"phoneExt":33,"email":33},"Karima BOUSSOUALIM, MD",{"name":212,"role":97,"phone":33,"phoneExt":33,"email":33},"Mijola LAMBERT, MD",{"type":214,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[216],{"name":217,"class":218},"Ministry of Health, France","OTHER_GOV","100286048",false,"NCT03003572","Autoreactive Anti-Ro\u002FSSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity","I GET DRY","Inclusion Criteria:\n\n* Primary Sjögren's syndrome according to the American-European Consensus Criteria)\n* Informed and having signed the study consent form\n\nExclusion Criteria:\n\n* Secondary Sjögren's syndrome\n* Other systemic autoimmune disease (e.g. rheumatoid arthritis, AntiNeutrophil Antibodies (ANCA) -associated vasculitis, mixed connective tissue disease…)\n* Incapacity or refusal to sign the informed consent form\n* Incapacity or refusal to perform the follow-up examinations required by the study\n* Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, Tumor Necrosis Factor (TNF) antagonists or interferon during the 6 months prior to the inclusion\n* Has any current signs or symptoms of active infection","ALL","18 Years",{"count":228,"type":229},185,"ESTIMATED","OBSERVATIONAL","Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to life-threatening conditions and is always responsible for a decreased quality of life. Its evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be carried out routinely is major in patients' follow-up. Because of the existence of autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for anti-Ro\u002FSSA antibodies in inducing interferon alpha (IFNα) signaling and the specific pharmacologic properties of IgE, anti-Ro\u002FSSA IgE should be an interesting biomarker to determine pSS's activity. The aim of the study is to evaluate whether the proportion of anti-Ro\u002FSSA IgE positive patients is higher in patients with active disease (i.e. Eular Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or already known diagnosis) will be included, Anti-Ro\u002FSSA IgE titers will be determined, the disease's features will be collected (including Eular Sjögren Syndrome Disease Activity Index\u002FEular Sjogren's Syndrome Patient Reported Index).",[233],"Primary Sjögren's Syndrome",[235,236,237,238,239],"Sjögren's syndrome","Immunoglobulin E","Anti-Ro\u002FSSA","Autoimmune disease","Biomarker","2026-05-05",{"date":242,"type":243},"2026-05-06","ACTUAL",{"date":245,"type":243},"2018-03-27",{"date":247,"type":229},"2027-06",{"name":5,"class":6},8]