[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614445":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":44,"locations":50,"responsibleParty":317,"collaborators":319,"id":323,"slug":324,"hasResults":325,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":325,"sex":331,"minAge":332,"maxAge":32,"enrollmentInfo":333,"targetDuration":32,"studyType":336,"phases":337,"briefSummary":339,"conditions":340,"keywords":32,"overallStatus":53,"whyStopped":32,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":351},{"fullName":5,"class":6},"University Hospital, Brest","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group 4 mg","ACTIVE_COMPARATOR","Oral baricitinib 4 mg for 12 weeks; Oral GCs prescribed at baseline Then, at week 12, if PMR-AS ≤10, patients will receive baricitinib 4 mg for 12 weeks. If PMR-AS \\>10, they will receive GCs according to the PMR-AS. Dosage of GCs will be decreased (1 mg every week) or increased according to PMR-AS (PMR-AS \\\u003C10: decrease, PMR-AS \\>20 increase, 10≤ PMR-AS ≤20: stable dose) according to investigator's opinion.",[13,14],"Drug: Baricitinib 4 MG Oral Tablet","Drug: Placebo 2 mg",{"label":16,"type":10,"description":17,"interventionNames":18},"Experimental group 2 mg","Oral baricitinib 2 mg for 12 weeks; Oral GCs prescribed at inclusion Then, at week 12, if PMR-AS ≤10, patients will receive baricitinib 2 mg for 12 weeks. If PMR-AS \\>10, they will receive GCs according to the PMR-AS. Dosage of GCs will be decreased (1 mg every week) or increased according to PMR-AS (PMR-AS \\\u003C10: decrease, PMR-AS \\>20 increase, 10≤ PMR-AS ≤20: stable dose) according to investigator's opinion.",[19,20],"Drug: Baricitinib 2 MG Oral Tablet","Drug: Placebo 4 mg",{"label":22,"type":23,"description":24,"interventionNames":25},"Control group","PLACEBO_COMPARATOR","Oral placebo for 12 weeks; Oral GCs at inclusion. Then, at week 12, if PMR-AS ≤10, placebo for 12 weeks. If PMR-AS \\>10, they will receive GCs according to the PMR-AS. Dosage of GCs will be decreased (1 mg every week) or increased according to PMR-AS (PMR-AS \\\u003C10: decrease, PMR-AS \\>20: increase, 10≤ PMR-AS ≤20: stable dose) and according to investigator's opinion.",[20,14],[27,33,37,41],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Baricitinib 4 MG Oral Tablet","Patient will take a tablet of 4 mg\u002Fd during 12 weeks and then 4 mg\u002Fd during 12 weeks if the patient achieves PMR-AS≤ 10 at week 12.",[9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Baricitinib 2 MG Oral Tablet","Patient will take a tablet of 2 mg\u002Fd during 12 weeks and then 2 mg\u002Fd during 12 weeks if the patient achieves PMR-AS≤ 10 at week 12.",[16],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Placebo 4 mg","Patient will take a tablet of placebo for 12 weeks and then placebo during 12 weeks if the patient achieves PMR-AS ≤ 10 at week 12.",[22,16],{"type":28,"name":42,"description":39,"armGroupLabels":43,"otherNames":32},"Placebo 2 mg",[22,9],[45],{"name":46,"role":47,"phone":48,"phoneExt":32,"email":49},"Alain SARAUX, Pr","CONTACT","+33298223333","alain.saraux@chu-brest.fr",[51,67,80,93,102,115,125,137,149,161,173,186,198,210,222,234,247,259,268,280,292,305],{"facility":52,"status":53,"city":54,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"VIDAL François","RECRUITING","Aix-en-Provence","France","FR",{"type":58,"coordinates":59},"Point",[60,61],5.44973,43.5283,{"lat":61,"lon":60},[64],{"name":65,"role":47,"phone":32,"phoneExt":32,"email":66},"François VIDAL, Dr","fvidal@ch-aix.fr",{"facility":68,"status":69,"city":70,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"LEGRAND Jean-Louis","NOT_YET_RECRUITING","Arras",{"type":58,"coordinates":72},[73,74],2.78186,50.29301,{"lat":74,"lon":73},[77],{"name":78,"role":47,"phone":32,"phoneExt":32,"email":79},"Jean-Louis LEGRAND, Dr","Jean-louis.legrand@gh-artoisternois.fr",{"facility":81,"status":53,"city":82,"state":32,"zip":83,"country":55,"countryCode":56,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Besançon-CIC","Besançon","25000",{"type":58,"coordinates":85},[86,87],6.01815,47.24878,{"lat":87,"lon":86},[90],{"name":91,"role":47,"phone":32,"phoneExt":32,"email":92},"Eric TOUSSIROT, Pr","etoussirot@chu-besancon.fr",{"facility":94,"status":53,"city":82,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":95,"geoPoint":97,"contacts":98},"PRATI Clément",{"type":58,"coordinates":96},[86,87],{"lat":87,"lon":86},[99],{"name":100,"role":47,"phone":32,"phoneExt":32,"email":101},"Clément PRATI, Pr","cprati@chu-besancon.fr",{"facility":103,"status":69,"city":104,"state":32,"zip":105,"country":55,"countryCode":56,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"CHU de Bordeaux Pellegrin","Bordeaux","33076",{"type":58,"coordinates":107},[108,109],-0.58046,44.84124,{"lat":109,"lon":108},[112],{"name":113,"role":47,"phone":32,"phoneExt":32,"email":114},"Marie-Elise TRUCHETET, Pr","marie-elise.truchetet@chu-bordeaux.fr",{"facility":116,"status":53,"city":117,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Dr Alain SARAUX","Brest",{"type":58,"coordinates":119},[120,121],-4.48628,48.39029,{"lat":121,"lon":120},[124],{"name":46,"role":47,"phone":48,"phoneExt":32,"email":49},{"facility":126,"status":53,"city":127,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"RAT Anne-Christine","Caen",{"type":58,"coordinates":129},[130,131],-0.35912,49.18585,{"lat":131,"lon":130},[134],{"name":135,"role":47,"phone":32,"phoneExt":32,"email":136},"Anne-Christine RAT, Pr","rat-ac@chu-caen.fr",{"facility":138,"status":53,"city":139,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"LESKE Charles","Cholet",{"type":58,"coordinates":141},[142,143],-0.87974,47.05893,{"lat":143,"lon":142},[146],{"name":147,"role":47,"phone":32,"phoneExt":32,"email":148},"LESKE Charles, Dr","charles.leske@ch-cholet.fr",{"facility":150,"status":69,"city":151,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"TOURNADRE Anne","Clermont-Ferrand",{"type":58,"coordinates":153},[154,155],3.08682,45.77969,{"lat":155,"lon":154},[158],{"name":159,"role":47,"phone":32,"phoneExt":32,"email":160},"Anne TOURNADRE, Pr","atournadre@chu-clermontferrand.fr",{"facility":162,"status":69,"city":163,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"RAMON André","Dijon",{"type":58,"coordinates":165},[166,167],5.01391,47.31344,{"lat":167,"lon":166},[170],{"name":171,"role":47,"phone":32,"phoneExt":32,"email":172},"André RAMON, Pr","andre.ramon@chu-dijon.fr",{"facility":174,"status":69,"city":175,"state":32,"zip":176,"country":55,"countryCode":56,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"APHP - Kremlin-Bicêtre","Le Kremlin-Bicêtre","94270",{"type":58,"coordinates":178},[179,180],2.36073,48.81471,{"lat":180,"lon":179},[183],{"name":184,"role":47,"phone":32,"phoneExt":32,"email":185},"Raphaele SEROR, Pr","raphaele.seror@aphp.fr",{"facility":187,"status":53,"city":188,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"DIREZ Guillaume","Le Mans",{"type":58,"coordinates":190},[191,192],0.20251,48.0021,{"lat":192,"lon":191},[195],{"name":196,"role":47,"phone":32,"phoneExt":32,"email":197},"Guillaume DIREZ, Dr","gdirez@ch-lemans.fr",{"facility":199,"status":69,"city":200,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"FLIPO René-Marc","Lille",{"type":58,"coordinates":202},[203,204],3.05512,50.63391,{"lat":204,"lon":203},[207],{"name":208,"role":47,"phone":32,"phoneExt":32,"email":209},"René-Marc FLIPO, Pr","Renemarc.FLIPO@chu-lille.fr",{"facility":211,"status":53,"city":212,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"WIRTH Théo","Marseille",{"type":58,"coordinates":214},[215,216],5.38107,43.29695,{"lat":216,"lon":215},[219],{"name":220,"role":47,"phone":32,"phoneExt":32,"email":221},"Théo WIRTH, Dr","Theo.WIRTH@ap-hm.fr",{"facility":223,"status":53,"city":224,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"LE HENAFF Catherine","Morlaix",{"type":58,"coordinates":226},[227,228],-3.82792,48.57784,{"lat":228,"lon":227},[231],{"name":232,"role":47,"phone":32,"phoneExt":32,"email":233},"Catherine LE HENAFF, Dr","CLehenaff@ch-morlaix.fr",{"facility":235,"status":53,"city":236,"state":32,"zip":237,"country":55,"countryCode":56,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"CHU de Nice","Nice","06000",{"type":58,"coordinates":239},[240,241],7.26608,43.70313,{"lat":241,"lon":240},[244],{"name":245,"role":47,"phone":32,"phoneExt":32,"email":246},"Christian ROUX, Pr","roux.c2@chu-nice.fr",{"facility":248,"status":69,"city":249,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":250,"geoPoint":254,"contacts":255},"FAUTREL Bruno - AP-HP La Pitié-Salpétrière","Paris",{"type":58,"coordinates":251},[252,253],2.3488,48.85341,{"lat":253,"lon":252},[256],{"name":257,"role":47,"phone":32,"phoneExt":32,"email":258},"Bruno FAUTREL, Pr","bruno.fautrel@aphp.fr",{"facility":260,"status":69,"city":249,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":261,"geoPoint":263,"contacts":264},"OTTAVIANI Sébastien - AP-HP Bichat",{"type":58,"coordinates":262},[252,253],{"lat":253,"lon":252},[265],{"name":266,"role":47,"phone":32,"phoneExt":32,"email":267},"Sébastien OTTAVIANI, Dr","sebastien.ottaviani@aphp.fr",{"facility":269,"status":69,"city":270,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"CHU Reims","Reims",{"type":58,"coordinates":272},[273,274],4.02853,49.26526,{"lat":274,"lon":273},[277],{"name":278,"role":47,"phone":32,"phoneExt":32,"email":279},"Jean-Hugues Salmon","jhsalmon@chu-reims.fr",{"facility":281,"status":53,"city":282,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":283,"geoPoint":287,"contacts":288},"GOTTENBERG Jacques-Eric","Strasbourg",{"type":58,"coordinates":284},[285,286],7.74553,48.58392,{"lat":286,"lon":285},[289],{"name":290,"role":47,"phone":32,"phoneExt":32,"email":291},"Jacques-Eric GOTTENBERG, Pr","jacques-eric.gottenberg@chru-strasbourg.fr",{"facility":293,"status":69,"city":294,"state":32,"zip":295,"country":55,"countryCode":56,"cosmosGeoPoint":296,"geoPoint":300,"contacts":301},"CHU de Toulouse","Toulouse","31059",{"type":58,"coordinates":297},[298,299],1.44367,43.60426,{"lat":299,"lon":298},[302],{"name":303,"role":47,"phone":32,"phoneExt":32,"email":304},"Adeline RUYSSEN-WITRAND, Pr","ruyssen-witrand.a@chu-toulouse.fr",{"facility":306,"status":53,"city":307,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":308,"geoPoint":312,"contacts":313},"CARVAJAL ALEGRIA Guillermo","Tours",{"type":58,"coordinates":309},[310,311],0.70398,47.39484,{"lat":311,"lon":310},[314],{"name":315,"role":47,"phone":32,"phoneExt":32,"email":316},"Guillermo CARVAJAL ALEGRIA, Dr","guillermo.carvajal@univ-tours.fr",{"type":318,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[320],{"name":321,"class":322},"Eli Lilly and Company","INDUSTRY","100614445","phase-3-justification-and-evaluation-of-baricitinib-plus-corticosteroids-versus-corticosteroids-alone-in-polymyalgia-rheumatica-100614445",false,"NCT07279688","Justification And Evaluation of Baricitinib Plus Corticosteroids Versus corticosteroiDs Alone in pOlymyalgia RhEumatica","Justification And Evaluation of Baricitinib Plus Corticosteroids Versus corticosteroiDs Alone in pOlymyalgia RhEumatica - JADORE-BARI Study","JADORE-BARI","Inclusion Criteria:\n\n* At least 50 years of age.\n* Fulfilling ACR\u002FEULAR classification criteria for PMR newly diagnosed or treatment resistant.\n* No GCs or GCs \\\u003C15 mg\u002Fday since at least 15 days prior to planned randomization.\n* PMR-AS-CRP \\>17.\n* Absence of other inflammatory arthropathy, connective tissue diseases or vasculitis.\n* Able to give informed consent.\n* French health insurance holder\n\nExclusion Criteria:\n\n* Clinical evidence of giant cell arteritis.\n* Uncontrolled high blood pressure or cardiovascular disease.\n* High risk of VTE because of a history of VTE (DVT and\u002For PE) within 12 weeks prior to randomization or a history of recurrent (\\>1) VTE (counting co-occurring DVT+PE as 1 single event).\n* Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR\n* Planned major surgical procedure during the study or medical history, blood abnormalities or any clinical condition that compromises inclusion.\n* Current smoker if age \\>65 years.\n* Current active uncontrolled infection.\n* Treatment by probenecid.\n* Alkaline phosphatase (ALP) ≥2 x ULN.\n* Total bilirubin level (TBL) ≥1.5 x ULN.\n* Neutropenia (absolute neutrophil count \\\u003C1000 cells\u002FuL) (\\\u003C1.00 x 103\u002FuL or \\\u003C1.00 GI\u002FL).\n* Lymphopenia (lymphocyte count \\\u003C500 cells\u002FuL) (\\\u003C0.50 x 103\u002FuL or \\\u003C0.50 GI\u002FL).\n* Patient under court protection or protected adults","ALL","50 Years",{"count":334,"type":335},140,"ESTIMATED","INTERVENTIONAL",[338],"PHASE3","Polymyalgia rheumatic (PMR) is an inflammatory rheumatic disease affecting the elderly. The diagnosis is based on established ACR\u002FEULAR classification criteria.\n\nThe activity of the disease is evaluated using the PMR-AS, a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment and pain assessment measured by the patient using VAS, and the C-reactive protein (CRP) level. The PMR-AS-CRP (PMR-AS) is considered as relevant to define disease activity (low activity \\\u003C7; moderate activity 7 to 17; high activity \\>17), flare (\\>10), remission (\\\u003C1.5), but also to decide if treatment has to be decreased, unchanged or increased (PMR-AS \\\u003C10: decrease, PMR-AS \\>20 increase, 10≤ PMR-AS ≤20: stable dose) \\[10-12\\].\n\nLong term low-dose glucocorticoid (GCs) (prednisone or prednisolone started at 12.5 to 25 mg\u002Fday progressively tapered) is the mainstay of the treatment. But comorbidities in PMR are due to GCs and 30% of the patients underwent a relapse when tapering GCs.\n\nToday, the physicians do not know what is the best duration and the best dosage of GCs. The international recommendation suggests to start prednisone at a dose between 12.5 to 25 mg, to be at 10 mg at 1 or 2 months, and then to decrease slowly. The treatment is generally ordered for 6-18 months but it is possible to try a shorter treatment duration when patients have been previously treated with GCs or in case of comorbidities.\n\nThe TENOR study, a phase 2 study, demonstrated efficacy of tocilizumab as first line treatment in PMR and its ability to spare GCs. The Semaphore study confirmed the usefulness of tocilizumab in corticodependent forms and demonstrated its efficacy. Another IL-6 inhibitor, sarilumab was authorized for the treatment for polymyalgia rheumatic in adult patients with inadequate response to corticosteroid or relapsing disease but is not reimbursed in France.\n\nBaricitinib is an oral selective JAK inhibitor of JAK1 and JAK2 with a short half-life. There are two dosages available (i.e., 2-mg and 4-mg) which can help conduct a simple dose tapering. Administration of baricitinib resulted in a rapid dose dependent inhibition of IL-6 induced STAT3 phosphorylation. An evaluation could be made using the PMR-AS with and without imputation to minimize the effect of baricitinib on CRP by anti-IL-6 effect.\n\nPreliminary results of the BACHELOR study (34 patients treated with baricitinib or placebo) suggested a great efficacy of baricitinib in early PMR without steroids.\n\nIt could be a treatment of PMR, with low dose or no steroids only during the first month, to minimize the adverse events of steroids. JAK inhibitors have been reevaluated by EMA, the Oral Surveillance study suggesting that tofacitinib (Xeljanz®) increases the risk of major cardiovascular problems, cancer, VTE, serious infections and death due to any cause when compared with medicines belonging to the class of TNF-alpha inhibitors. EMA has concluded that these safety findings apply to all approved uses of JAK inhibitors in chronic inflammatory disorders. Nevertheless, the risk was not increased during the first months of treatment in all studies and a short treatment could have lower risks than steroids.\n\nAs no suitable treatment alternatives are available, excepted GCs which increase the vascular risk and osteoporosis, short treatment by jak inhibitor could be a relevant alternative treatment of PMR. Indeed, the physicians do not have any disease modifying drug (excepted anti IL6 off-label) in treatment of PMR. So, GCs are used for more than one year in the treatment of PMR. Baricitinib, used only 6 months demonstrated its ability to cure early PMR without steroids. It could be an alternative to steroid when physicians consider that ratio benefit\u002Frisk is better with a 6 months treatment by baricitininib than \\>one year by steroids.\n\nOur goal is now to demonstrate in a large cohort the ability of a 6-month treatment with baricitinib in comparison to placebo to decrease glucocorticoids and then to maintain low disease activity without corticosteroids in PMR and a good safety profile.\n\nDue to the possible lower risk of 2 mg than 4 mg of baricitinib, but probably a lower efficacy, the investigators plan to compare both baricitinib (4 mg and 2 mg) to placebo. The study will be conducted in France.",[341],"Polymyalgia Rheumatica (PMR)","2026-06-09",{"date":344,"type":345},"2026-06-10","ACTUAL",{"date":347,"type":345},"2025-12-18",{"date":349,"type":335},"2029-06",{"name":5,"class":6},22]