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221914","Guadalajara","Jalisco","44160",{"type":72,"coordinates":593},[594,595],-103.34749,20.67738,{"lat":595,"lon":594},{"facility":598,"status":48,"city":589,"state":590,"zip":599,"country":580,"countryCode":581,"cosmosGeoPoint":600,"geoPoint":602,"contacts":48},"Centro de Estudios de Investigación Básica y Clínica, S.C. \u002FID# 221910","44690",{"type":72,"coordinates":601},[594,595],{"lat":595,"lon":594},{"facility":604,"status":48,"city":605,"state":605,"zip":606,"country":580,"countryCode":581,"cosmosGeoPoint":607,"geoPoint":611,"contacts":48},"RM Pharma Specialists S.A de C.V. \u002FID# 221915","Mexico City","03100",{"type":72,"coordinates":608},[609,610],-99.12766,19.42847,{"lat":610,"lon":609},{"facility":613,"status":48,"city":605,"state":605,"zip":614,"country":580,"countryCode":581,"cosmosGeoPoint":615,"geoPoint":617,"contacts":48},"CINTRE, Centro de Investigación y Tratamiento Reumatológico SC \u002FID# 221913","11850",{"type":72,"coordinates":616},[609,610],{"lat":610,"lon":609},{"facility":619,"status":48,"city":620,"state":621,"zip":622,"country":580,"countryCode":581,"cosmosGeoPoint":623,"geoPoint":627,"contacts":48},"Medical Care & Research SA de CV \u002FID# 221911","Mérida","Yucatán","97070",{"type":72,"coordinates":624},[625,626],-89.62318,20.967,{"lat":626,"lon":625},{"facility":629,"status":48,"city":630,"state":631,"zip":632,"country":633,"countryCode":634,"cosmosGeoPoint":635,"geoPoint":639,"contacts":48},"North Shore Hospital \u002FID# 221850","Takapuna","Auckland","0622","New Zealand","NZ",{"type":72,"coordinates":636},[637,638],174.77583,-36.79167,{"lat":638,"lon":637},{"facility":641,"status":48,"city":642,"state":643,"zip":644,"country":645,"countryCode":646,"cosmosGeoPoint":647,"geoPoint":651,"contacts":48},"Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi \u002FID# 221859","Poznan","Greater Poland Voivodeship","61-545","Poland","PL",{"type":72,"coordinates":648},[649,650],16.92993,52.40692,{"lat":650,"lon":649},{"facility":653,"status":48,"city":654,"state":655,"zip":656,"country":645,"countryCode":646,"cosmosGeoPoint":657,"geoPoint":661,"contacts":48},"Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. \u002FID# 224430","Krakow","Lesser Poland Voivodeship","31-011",{"type":72,"coordinates":658},[659,660],19.93658,50.06143,{"lat":660,"lon":659},{"facility":663,"status":48,"city":664,"state":665,"zip":666,"country":645,"countryCode":646,"cosmosGeoPoint":667,"geoPoint":671,"contacts":48},"WroMedica I. Bielicka, A. Strzalkowska s.c. \u002FID# 221860","Wroclaw","Lower Silesian Voivodeship","51-685",{"type":72,"coordinates":668},[669,670],17.03006,51.10286,{"lat":670,"lon":669},{"facility":673,"status":48,"city":674,"state":675,"zip":676,"country":645,"countryCode":646,"cosmosGeoPoint":677,"geoPoint":681,"contacts":48},"MTZ Clinical Research Powered by Pratia \u002FID# 224431","Warsaw","Masovian Voivodeship","02-172",{"type":72,"coordinates":678},[679,680],21.01178,52.22977,{"lat":680,"lon":679},{"facility":683,"status":48,"city":684,"state":48,"zip":685,"country":686,"countryCode":687,"cosmosGeoPoint":688,"geoPoint":692,"contacts":48},"GCM Medical Group PSC \u002FID# 224394","San Juan","00917-3104","Puerto Rico","PR",{"type":72,"coordinates":689},[690,691],-66.10572,18.46633,{"lat":691,"lon":690},{"facility":694,"status":48,"city":684,"state":48,"zip":695,"country":686,"countryCode":687,"cosmosGeoPoint":696,"geoPoint":698,"contacts":48},"Mindful Medical Research \u002FID# 222513","00918-3756",{"type":72,"coordinates":697},[690,691],{"lat":691,"lon":690},{"facility":700,"status":48,"city":701,"state":702,"zip":703,"country":704,"countryCode":48,"cosmosGeoPoint":705,"geoPoint":709,"contacts":48},"Seoul National University Hospital \u002FID# 221897","Seoul","Seoul Teugbyeolsi","03080","South Korea",{"type":72,"coordinates":706},[707,708],126.9784,37.566,{"lat":708,"lon":707},{"facility":711,"status":48,"city":712,"state":713,"zip":714,"country":715,"countryCode":716,"cosmosGeoPoint":717,"geoPoint":721,"contacts":48},"HUA - Txagorritxu \u002FID# 221992","Vitoria-Gasteiz","Alava","01009","Spain","ES",{"type":72,"coordinates":718},[719,720],-2.67268,42.84998,{"lat":720,"lon":719},{"facility":723,"status":48,"city":724,"state":725,"zip":726,"country":715,"countryCode":716,"cosmosGeoPoint":727,"geoPoint":731,"contacts":48},"Consorci Corporacio Sanitaria Parc Tauli Sabadell \u002FID# 221995","Sabadell","Barcelona","08208",{"type":72,"coordinates":728},[729,730],2.10942,41.54329,{"lat":730,"lon":729},{"facility":733,"status":48,"city":734,"state":735,"zip":736,"country":715,"countryCode":716,"cosmosGeoPoint":737,"geoPoint":741,"contacts":48},"Hospital Universitario Basurto \u002FID# 221999","Bilbao","Vizcaya","48013",{"type":72,"coordinates":738},[739,740],-2.92528,43.26271,{"lat":740,"lon":739},{"facility":743,"status":48,"city":744,"state":735,"zip":745,"country":715,"countryCode":716,"cosmosGeoPoint":746,"geoPoint":750,"contacts":48},"Hospital Universitario de Galdakao \u002FID# 221996","Galdakao","48960",{"type":72,"coordinates":747},[748,749],-2.8429,43.23073,{"lat":749,"lon":748},{"facility":752,"status":48,"city":753,"state":48,"zip":754,"country":715,"countryCode":716,"cosmosGeoPoint":755,"geoPoint":759,"contacts":48},"Duplicate_Hospital Universitario A Coruna - CHUAC \u002FID# 221993","A Coruña","15006",{"type":72,"coordinates":756},[757,758],-8.396,43.37135,{"lat":758,"lon":757},{"facility":761,"status":48,"city":762,"state":48,"zip":763,"country":715,"countryCode":716,"cosmosGeoPoint":764,"geoPoint":768,"contacts":48},"Hospital Universitario 12 de Octubre \u002FID# 221994","Madrid","28041",{"type":72,"coordinates":765},[766,767],-3.70256,40.4165,{"lat":767,"lon":766},{"facility":770,"status":48,"city":771,"state":48,"zip":772,"country":715,"countryCode":716,"cosmosGeoPoint":773,"geoPoint":777,"contacts":48},"Hospital Universitario Virgen de Valme \u002FID# 221997","Seville","41014",{"type":72,"coordinates":774},[775,776],-5.97317,37.38283,{"lat":776,"lon":775},{"facility":779,"status":48,"city":780,"state":48,"zip":781,"country":715,"countryCode":716,"cosmosGeoPoint":782,"geoPoint":786,"contacts":48},"Hospital Universitario y Politecnico La Fe \u002FID# 221998","Valencia","46026",{"type":72,"coordinates":783},[784,785],-0.37966,39.47391,{"lat":785,"lon":784},{"facility":788,"status":48,"city":789,"state":790,"zip":791,"country":792,"countryCode":793,"cosmosGeoPoint":794,"geoPoint":798,"contacts":48},"Taichung Veterans General Hospital \u002FID# 221748","Taichung","Keelung","40705","Taiwan","TW",{"type":72,"coordinates":795},[796,797],120.6839,24.1469,{"lat":797,"lon":796},{"facility":800,"status":48,"city":801,"state":790,"zip":802,"country":792,"countryCode":793,"cosmosGeoPoint":803,"geoPoint":807,"contacts":48},"Taipei Veterans General Hosp \u002FID# 221746","Taipei","11217",{"type":72,"coordinates":804},[805,806],121.52639,25.05306,{"lat":806,"lon":805},{"facility":809,"status":48,"city":810,"state":801,"zip":811,"country":792,"countryCode":793,"cosmosGeoPoint":48,"geoPoint":48,"contacts":48},"National Taiwan University Hospital \u002FID# 221745","Taipei City","100",{"facility":813,"status":48,"city":789,"state":48,"zip":814,"country":792,"countryCode":793,"cosmosGeoPoint":815,"geoPoint":817,"contacts":48},"China Medical University Hospital \u002FID# 221747","40447",{"type":72,"coordinates":816},[796,797],{"lat":797,"lon":796},{"facility":819,"status":48,"city":801,"state":48,"zip":820,"country":792,"countryCode":793,"cosmosGeoPoint":821,"geoPoint":823,"contacts":48},"Taipei Medical University Hospital \u002FID# 227653","11031",{"type":72,"coordinates":822},[805,806],{"lat":806,"lon":805},{"facility":825,"status":48,"city":826,"state":48,"zip":827,"country":792,"countryCode":793,"cosmosGeoPoint":828,"geoPoint":832,"contacts":48},"Linkou Chang Gung Memorial Hospital \u002FID# 222469","Taoyuan City","333",{"type":72,"coordinates":829},[830,831],121.29696,24.99368,{"lat":831,"lon":830},{"facility":834,"status":48,"city":835,"state":836,"zip":837,"country":838,"countryCode":839,"cosmosGeoPoint":840,"geoPoint":844,"contacts":48},"Guys and St Thomas NHS Foundation Trust \u002FID# 221863","London","London, City of","SE1 9RT","United Kingdom","UK",{"type":72,"coordinates":841},[842,843],-0.12574,51.50853,{"lat":843,"lon":842},{"facility":846,"status":48,"city":847,"state":48,"zip":848,"country":838,"countryCode":839,"cosmosGeoPoint":849,"geoPoint":853,"contacts":48},"Duplicate_Manchester University NHS Foundation Trust \u002FID# 221861","Manchester","M13 9WL",{"type":72,"coordinates":850},[851,852],-2.23743,53.48095,{"lat":852,"lon":851},{"type":855,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100397180","phase-2-a-study-of-the-safety-of-oral-elsubrutinib-capsules-and-oral-upadacitinib-tablets-given-alone-or-in-combination-abbv-599-for-adult-participants-with-moderately-to-severely-active-systemic-lupus-erythematosus-to-assess-change-in-disease-state-100397180",true,"NCT04451772","A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State","A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)","Inclusion Criteria:\n\n* Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib, upadacitinib, and ABBV-599 \\[elsubrutinib\u002Fupadacitinib\\] combination or matching placebo) and will not have developed any laboratory or clinical discontinuation criteria as defined in that study.\n* On stable background treatment for SLE throughout the study.\n\nExclusion Criteria:\n\n* Active, chronic, or recurrent viral, or bacterial infection.\n* Active tuberculosis (TB)\n* History of gastrointestinal (GI) perforation, diverticulitis, or a significantly increased risk for GI perforation per investigator assessment.\n* Participant require vaccination with live vaccine during study participation.",false,"ALL","18 Years","65 Years",{"count":868,"type":869},185,"ACTUAL","INTERVENTIONAL",[872],"PHASE2","Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib\u002Fupadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms.\n\nABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is \"double-blinded\", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 100 sites worldwide.\n\nParticipants will receive the following for up to 56 weeks:\n\nParticipants will receive oral elsubrutinib capsules and\u002For oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and\u002For upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study.\n\nArm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B\n\nThere may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[875],"Systemic Lupus Erythematosus (SLE)",[877,878,44,54,40,50],"Systemic Lupus Erythematosus","ABBV-599","COMPLETED","2024-12-19",{"date":882,"type":869},"2025-01-14",{"date":884,"type":869},"2020-07-27",{"date":886,"type":869},"2024-01-03",{"name":5,"class":6},87]