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active disease starting Upadacitinib",[13],"Drug: Upadacitinib 15 MG [Rinvoq]",{"label":15,"type":10,"description":16,"interventionNames":17},"Psoriatic Arthritis","Patients diagnosed with peripheral Psoriatic Arthritis according to the CASPAR criteria or with axial Psoriatic Arthritis according to ASAS criteria with active disease starting Upadacitinib",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Upadacitinib 15 MG [Rinvoq]","15 mg\u002F day",[15,9],[25],{"name":26,"affiliation":27,"role":28},"Georgios Filippou, MD","Università degli Studi di Milano \u002F IRCCS Ospedale Galeazzi-Sant'Ambrogio","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","0039 0283502707","georgios.filippou@grupposandonato.it",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Silvia Sirotti, MD","0039 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0282241","marta.caprioli78@gmail.com",{"name":70,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":75,"status":41,"city":76,"state":43,"zip":77,"country":45,"countryCode":46,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"IRCCS Policlinico San Donato","San Donato","20097",{"type":48,"coordinates":79},[80,81],7.66485,45.08201,{"lat":81,"lon":80},[84,88],{"name":85,"role":31,"phone":86,"phoneExt":10,"email":87},"Nikoleta Vaso, MD","0039 02527741","nikoleta.vaso@grupposandonato.it",{"name":85,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":90,"status":41,"city":91,"state":92,"zip":93,"country":45,"countryCode":46,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"IRCCS Ospedale Galeazzi-Sant'Ambrogio,","Milan","Mi","20157",{"type":48,"coordinates":95},[96,97],12.59836,42.78235,{"lat":97,"lon":96},[100,102,103,105],{"name":26,"role":31,"phone":101,"phoneExt":10,"email":33},"0039 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XXIII","Bergamo","24127",{"type":48,"coordinates":128},[129,130],9.66721,45.69601,{"lat":130,"lon":129},[133,137],{"name":134,"role":31,"phone":135,"phoneExt":10,"email":136},"Eleonora Bruschi, MD","0039 035267111","eleonorabruschi@virgilio.it",{"name":134,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":139,"status":41,"city":140,"state":10,"zip":141,"country":45,"countryCode":46,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"ASST Spedali Civili","Brescia","25153",{"type":48,"coordinates":143},[144,145],10.21472,45.53558,{"lat":145,"lon":144},[148,152],{"name":149,"role":31,"phone":150,"phoneExt":10,"email":151},"Matteo Filippini, MD","0039 03039951","matteofilippini@icloud.com",{"name":149,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":154,"status":41,"city":91,"state":10,"zip":155,"country":45,"countryCode":46,"cosmosGeoPoint":156,"geoPoint":158,"contacts":159},"ASST Gaetano Pini 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Niguarda","20162",{"type":48,"coordinates":181},[96,97],{"lat":97,"lon":96},[184,188,189],{"name":185,"role":31,"phone":186,"phoneExt":10,"email":187},"Oscar Massimiliano Epis, MD","0039 0264441","oscar.epis@ospedaleniguarda.it",{"name":185,"role":28,"phone":10,"phoneExt":10,"email":10},{"name":190,"role":104,"phone":10,"phoneExt":10,"email":10},"Antonella Adinolfi, MD",{"facility":192,"status":41,"city":91,"state":10,"zip":10,"country":45,"countryCode":46,"cosmosGeoPoint":193,"geoPoint":195,"contacts":196},"ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco",{"type":48,"coordinates":194},[96,97],{"lat":97,"lon":96},[197,201],{"name":198,"role":31,"phone":199,"phoneExt":10,"email":200},"Bruno Lucchino, MD","0039 0239041","lucchino.bruno@asst-fbf-sacco.it",{"name":198,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":203,"status":41,"city":204,"state":10,"zip":205,"country":45,"countryCode":46,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Fondazione IRCCS Policlinico San Matteo","Pavia","27100",{"type":48,"coordinates":207},[208,209],9.15917,45.19205,{"lat":209,"lon":208},[212,216],{"name":213,"role":31,"phone":214,"phoneExt":10,"email":215},"Ludovico De Stefano, MD","0039 03825011","ludovico.destefano01@universitadipavia.it",{"name":213,"role":104,"phone":10,"phoneExt":10,"email":10},{"facility":218,"status":41,"city":204,"state":10,"zip":205,"country":45,"countryCode":46,"cosmosGeoPoint":219,"geoPoint":221,"contacts":222},"IRCCS Istituti Clinici Scientifici Maugeri",{"type":48,"coordinates":220},[208,209],{"lat":209,"lon":208},[223,227],{"name":224,"role":31,"phone":225,"phoneExt":10,"email":226},"Garifallia Sakellariou, MD","0039 03825921","filiciasak@gmail.com",{"name":224,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":229,"status":41,"city":230,"state":10,"zip":231,"country":45,"countryCode":46,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"ASST Settelaghi - Ospedale di Circolo di Varese","Varese","21100",{"type":48,"coordinates":233},[234,235],8.82511,45.82058,{"lat":235,"lon":234},[238,242],{"name":239,"role":31,"phone":240,"phoneExt":10,"email":241},"Alberto Batticciotto, MD","0039 0332 278111","alberto.batticciotto@asst-settelaghi.it",{"name":243,"role":28,"phone":10,"phoneExt":10,"email":10},"Alberto Batticciotto,, MD",{"type":245,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100564556","efficacy-of-upadacitinib-in-psoriatic-arthritis-and-comparison-to-rheumatoid-arthritis-100564556",false,"NCT06630715","Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis.","Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis. OPTimising IMAging For The Use In The Follow-Up Of Arthritis: The OPTIMA Study","OPTIMA","The inclusion criteria for Psoriatic Arthritis patients are:\n\n1. Patients diagnosed with peripheral Psoriatic Arthritis according to the CASPAR criteria or with axial Psoriatic Arthritis according to ASAS criteria and with at least one of the following:\n\n   1. With active peripheral Psoriatic Arthritis regarding ongoing therapy in one of the following sites: MCP joints 1-5, proximal interphalangeal (PIP) joints of hands 1-5, distal interphalangeal (DIP) joints of hands 2-5, wrists, elbows, knees and ankles\u002Fheels and feet, according to any of the following criteria:\n\n      I) DAPSA ≥ 15 and joint inflammation according to the Global OMERACT-EULAR US scoring for synovitis and power Doppler (GLOESS) with a grade at patient level \\>3,2\n\n      II) With a clinical enthesitis and an active enthesitis (positive power Doppler of any grade), in the clinical symptomatic site, according to the OMERACT US definitions\n\n      III) With active dactylitis (clinical diagnosis made by the physician at the time of baseline visit) and a positive US dactylitis according to the DACTylitis glObal Sonographic (DACTOS) score \\>3\n\n      IV) DAPSA ≥ 15 and tenosynovitis according to the OMERACT US scoring system for tenosynovitis with a grade \\>1\n   2. With active axial PsA regarding ongoing therapy (ASDAS ≥ 2.1) and active sacroiliitis according to the ASAS MRI definitions\n2. Who are eligible according to the current guidelines\u002Fregulations to start treatment with UPA and present a favorable risk\u002Fbenefit profile according to the clinician's opinion for such treatment.\n3. Aged older than 18 years.\n4. Able to provide informed consent, according to requirements of local IRB\u002Fethics committee.\n\nThe inclusion criteria for Rheumatoid Arthritis patients are:\n\n1. Patients diagnosed with RA according to the ACR\u002FEULAR 2010 classification criteria\n2. With active Rheumatoid Arthritis according to the following criteria: DAS28-PCR \\>3.2, and the presence of at least one US finding of the following:\n\n   1. Joint inflammation at hands and wrists according to the Global OMERACT-EULAR (GLOESS) US scoring for synovitis and power Doppler with a grade at patient level \\>2\n   2. One tenosynovitis at hands or wrists, according to the OMERACT US scoring system for tenosynovitis with a grade \\>1\n3. Who are eligible according to the current guidelines\u002Fregulations to start treatment with Upadacitinib and present a favourable risk\u002Fbenefit profile according to the clinician's opinion for such treatment.\n4. Aged older than 18 years.\n5. Able to provide informed consent, according to requirements of local IRB\u002Fethics committee.\n\nExclusion Criteria:\n\n1. Patients with any contraindication to Upadacitinib:\n\n   1. women who are pregnant or breastfeeding\n   2. active infection\n   3. evidence of tuberculosis infection\n   4. known infection with human immunodeficiency virus or hepatitis B or C\n   5. patients who have current malignancy or history of malignancy in the last 5 years\n   6. high cardiovascular risk\n   7. high risk of venous thromboembolism\n   8. patients with severe hepatic impairment\n2. Patients with associated fibromyalgia syndrome according to the 2016 ACR diagnostic criteria\n3. Unable to provide informed consent, according to requirements of local IRB\u002Fethics committee.","ALL","18 Years",{"count":257,"type":258},178,"ESTIMATED","OBSERVATIONAL","The general objective of the OPTIMA study is to assess the time course and interrelationship of imaging (ultrasound and magnetic resonance imaging), clinical, laboratory, and Patient Reported Outcome variables in patients with active Psoriatic Arthritis (any subset) and Rheumatoid Arthritis starting therapy with a Jak-Inhibitor (Upadacitinib), during the first 6 months of follow-up.\n\nParticipants will be evaluated at the start of therapy with upadacitinib and during the follow-up visits at 2 weeks, 1, 3, and 6 months post-treatment initiation. At each visit (with the exception of the 2-weeks visit), data relating to the clinical evaluation, laboratory tests, and ultrasound of the affected joints will be collected according to standard clinical practice; questionnaires on disease activity will also be completed. In the case of axial involvement, a magnetic resonance imaging will be performed at baseline and after 6 months of therapy, only if required by the standard of care.",[262,263],"Rheumatoid Arthritis (RA","Psoriatic Arthritis (PsA",[265,15,266,267,268,269,270,271,272],"rheumathoid Arthritis","Ultrasound","MRI","Upadacitinib","Dactylitis","Enthesitis","Synovitis","sacroiliitis","2024-10-04",{"date":275,"type":276},"2024-10-08","ACTUAL",{"date":278,"type":276},"2024-07-23",{"date":280,"type":258},"2025-12",{"name":5,"class":6},14]