[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05936970":3,"trial-entities:NCT05936970":367,"trial-summary:NCT05936970":370},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":27,"secondary_outcomes":32,"sex":33,"minimum_age":34,"maximum_age":21,"healthy_volunteers":14,"eligibility_criteria":35,"std_ages":46,"locations":49,"central_contacts":359,"overall_officials":360,"references":365,"see_also_links":366},"NCT05936970","PRIMA - 102","Prospective, Multi-Center, Observational, Whole Blood Specimen Collection Study in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to a DMARD Starting a New bDMARD or tsDMARD Treatment +\u002F- csDMARD","ACTIVE_NOT_RECRUITING","2028-06","2026-07","2026-07-21","2023-06-29","Aqtual, Inc.","INDUSTRY",false,"The primary goal of this study is to assess a cfDNA-based blood test using genetic, transcriptomic and\u002For epigenetic information to help doctors predict the best treatment options for rheumatoid arthritis (RA) patients with inadequate response or intolerance to previous therapies.","PRIMA - 102 aims to predict response to bDMARD or tsDMARD therapy through analysis of cfDNA in blood. PRIMA - 102 will enroll participants with inadequate response or intolerance to previous therapies. Participants will undergo screening and baseline visits, followed by the initiation of new bDMARD or tsDMARD therapy per standard of care. The study will evaluate treatment response and disease activity at a 12-week follow-up visit. Blood will be drawn and Clinical Outcome Assessments performed at baseline and at the 12-week follow-up visit.",[18],"Rheumatoid Arthritis",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},1410,"ESTIMATED",[],[28],{"measure":29,"description":30,"timeFrame":31},"Clinical Response Prediction","This study aims to identify cfDNA signatures that predict response to specific bDMARD or tsDMARD therapies for RA treatment.","Approximately 3 months",[],"ALL","18 Years",{"inclusion":36,"exclusion":43,"raw_text":45},[37,38,39,40,41,42],"Ability to understand and provide written informed consent.","Male or female ≥18 years of age at enrollment.","Diagnosis of Rheumatoid Arthritis at the time of enrollment.","Prior treatment with at least 1 csDMARD, bDMARD, or tsDMARD","Planning to initiate a new bDMARD (+\u002F- csDMARD) or tsDMARD (+\u002F- csDMARD), within 1 month after enrollment.","Moderate to high Clinical Disease Activity Index (CDAI) of (\\>10) with a minimum 4 tender joints and 4 swollen joints at the time of screening.",[44],"Unsuitable for participation in the opinion of the principal investigator.","Inclusion Criteria:\n\n* Ability to understand and provide written informed consent.\n* Male or female ≥18 years of age at enrollment.\n* Diagnosis of Rheumatoid Arthritis at the time of enrollment.\n* Prior treatment with at least 1 csDMARD, bDMARD, or tsDMARD\n* Planning to initiate a new bDMARD (+\u002F- csDMARD) or tsDMARD (+\u002F- csDMARD), within 1 month after enrollment.\n* Moderate to high Clinical Disease Activity Index (CDAI) of (\\>10) with a minimum 4 tender joints and 4 swollen joints at the time of screening.\n\nExclusion Criteria:\n\n* Unsuitable for participation in the opinion of the principal investigator.",[47,48],"ADULT","OLDER_ADULT",[50,59,67,74,81,88,95,103,110,117,124,131,138,145,152,159,167,175,182,190,198,206,214,222,230,237,245,253,260,267,274,282,290,297,300,308,316,323,330,337,344,352],{"facility":51,"city":52,"state":53,"zip":54,"country":55,"geoPoint":56},"Arizona Arthritis & Rheumatology Research","Phoenix","Arizona","85032","United States",{"lat":57,"lon":58},33.44838,-112.07404,{"facility":60,"city":61,"state":62,"zip":63,"country":55,"geoPoint":64},"Medvin Clinical Research - Apple Valley","Apple Valley","California","92307",{"lat":65,"lon":66},34.50083,-117.18588,{"facility":68,"city":69,"state":62,"zip":70,"country":55,"geoPoint":71},"Medvin Clinical Research - Covina","Covina","91722",{"lat":72,"lon":73},34.09001,-117.89034,{"facility":75,"city":76,"state":62,"zip":77,"country":55,"geoPoint":78},"Medvin Clinical Research - Riverside","Riverside","92518",{"lat":79,"lon":80},33.95335,-117.39616,{"facility":82,"city":83,"state":62,"zip":84,"country":55,"geoPoint":85},"Medvin Clinical Research - Tujunga","Tujunga","91042",{"lat":86,"lon":87},34.25223,-118.28841,{"facility":89,"city":90,"state":62,"zip":91,"country":55,"geoPoint":92},"Medvin Clinical Research - Whittier","Whittier","90602",{"lat":93,"lon":94},33.97918,-118.03284,{"facility":96,"city":97,"state":98,"zip":99,"country":55,"geoPoint":100},"AARDS Research, Inc","Aventura","Florida","33180",{"lat":101,"lon":102},25.95648,-80.13921,{"facility":104,"city":105,"state":98,"zip":106,"country":55,"geoPoint":107},"Highlands Advanced Rheumatology and Arthritis Center (HARAC)","Avon Park","33825",{"lat":108,"lon":109},27.59587,-81.50619,{"facility":111,"city":112,"state":98,"zip":113,"country":55,"geoPoint":114},"Bay Area Rheumatology","Clearwater","33765",{"lat":115,"lon":116},27.96585,-82.8001,{"facility":118,"city":119,"state":98,"zip":120,"country":55,"geoPoint":121},"Believe Clinical Trials","Coral Springs","33065",{"lat":122,"lon":123},26.27119,-80.2706,{"facility":125,"city":126,"state":98,"zip":127,"country":55,"geoPoint":128},"GNP Research","Hollywood","33024",{"lat":129,"lon":130},26.0112,-80.14949,{"facility":132,"city":133,"state":98,"zip":134,"country":55,"geoPoint":135},"Life Clinical Trials","Margate","33063",{"lat":136,"lon":137},26.24453,-80.20644,{"facility":139,"city":140,"state":98,"zip":141,"country":55,"geoPoint":142},"Vitalia Medical Research","Palm Beach Gardens","33410",{"lat":143,"lon":144},26.82339,-80.13865,{"facility":146,"city":147,"state":98,"zip":148,"country":55,"geoPoint":149},"Shine a Light Research","Sun City Center","33573",{"lat":150,"lon":151},27.71809,-82.35176,{"facility":153,"city":154,"state":98,"zip":155,"country":55,"geoPoint":156},"West Broward Rheumatology Associates","Tamarac","33321",{"lat":157,"lon":158},26.21286,-80.24977,{"facility":160,"city":161,"state":162,"zip":163,"country":55,"geoPoint":164},"St. Luke's Clinic","Boise","Idaho","83712",{"lat":165,"lon":166},43.6135,-116.20345,{"facility":168,"city":169,"state":170,"zip":171,"country":55,"geoPoint":172},"Arnold Arthritis & Rheumatology","Skokie","Illinois","60076",{"lat":173,"lon":174},42.03336,-87.73339,{"facility":176,"city":177,"state":170,"zip":178,"country":55,"geoPoint":179},"Illinois Bone and Joint Institute","Willowbrook","60527",{"lat":180,"lon":181},41.76975,-87.93589,{"facility":183,"city":184,"state":185,"zip":186,"country":55,"geoPoint":187},"Lake Cumberland Rheumatology","New Albany","Indiana","47150",{"lat":188,"lon":189},38.28562,-85.82413,{"facility":191,"city":192,"state":193,"zip":194,"country":55,"geoPoint":195},"Clinical Research Institute of Michigan","Saint Clair Shores","Michigan","48082",{"lat":196,"lon":197},42.49698,-82.88881,{"facility":199,"city":200,"state":201,"zip":202,"country":55,"geoPoint":203},"St. Paul Rheumatology","Eagan","Minnesota","55121",{"lat":204,"lon":205},44.80413,-93.16689,{"facility":207,"city":208,"state":209,"zip":210,"country":55,"geoPoint":211},"AARA\u002FKansas City Physician Partners","Kansas City","Missouri","64151",{"lat":212,"lon":213},39.09973,-94.57857,{"facility":215,"city":216,"state":217,"zip":218,"country":55,"geoPoint":219},"New England Rheumatology & Osteoporosis","Henniker","New Hampshire","03242",{"lat":220,"lon":221},43.1798,-71.8223,{"facility":223,"city":224,"state":225,"zip":226,"country":55,"geoPoint":227},"Arthritis Rheumatism and Bone Disease Associates","Voorhees Township","New Jersey","08043",{"lat":228,"lon":229},40.4795,-74.49062,{"facility":231,"city":232,"state":225,"zip":233,"country":55,"geoPoint":234},"Sahni Rheumatology & Therapy","West Long Branch","07764",{"lat":235,"lon":236},40.29039,-74.01764,{"facility":238,"city":239,"state":240,"zip":241,"country":55,"geoPoint":242},"Albuquerque Center for Rheumatology","Albuquerque","New Mexico","87102",{"lat":243,"lon":244},35.08449,-106.65114,{"facility":246,"city":247,"state":248,"zip":249,"country":55,"geoPoint":250},"Arthritis and Osteoporosis Consultants of the Carolinas","Charlotte","North Carolina","28207",{"lat":251,"lon":252},35.22709,-80.84313,{"facility":254,"city":255,"state":248,"zip":256,"country":55,"geoPoint":257},"Cape Fear Arthritis Care","Leland","28451",{"lat":258,"lon":259},34.25628,-78.04471,{"facility":261,"city":262,"state":248,"zip":263,"country":55,"geoPoint":264},"Triangle Arthritis & Rheumatology","Raleigh","27612",{"lat":265,"lon":266},35.7721,-78.63861,{"facility":268,"city":269,"state":248,"zip":270,"country":55,"geoPoint":271},"Carolina Arthritis Associates","Wilmington","28401",{"lat":272,"lon":273},34.23556,-77.94604,{"facility":275,"city":276,"state":277,"zip":278,"country":55,"geoPoint":279},"AARA\u002FRheumatic Diseases Clinic of Oklahoma","Oklahoma City","Oklahoma","73102",{"lat":280,"lon":281},35.46756,-97.51643,{"facility":283,"city":284,"state":285,"zip":286,"country":55,"geoPoint":287},"Altoona Center for Clinical Research","Duncansville","Pennsylvania","16635",{"lat":288,"lon":289},40.42341,-78.4339,{"facility":291,"city":292,"state":285,"zip":293,"country":55,"geoPoint":294},"Arthritis Group Rheumatology","Philadelphia","19152",{"lat":295,"lon":296},39.95238,-75.16362,{"facility":298,"city":292,"state":285,"zip":293,"country":55,"geoPoint":299},"PA Regional Center for Arthritis and Osteoporosis Research",{"lat":295,"lon":296},{"facility":301,"city":302,"state":303,"zip":304,"country":55,"geoPoint":305},"Carolina Health Specialists\u002FTrial Management Associates","Myrtle Beach","South Carolina","29572",{"lat":306,"lon":307},33.68906,-78.88669,{"facility":309,"city":310,"state":311,"zip":312,"country":55,"geoPoint":313},"Accurate Clinical Management","Baytown","Texas","77521",{"lat":314,"lon":315},29.7355,-94.97743,{"facility":317,"city":318,"state":311,"zip":319,"country":55,"geoPoint":320},"Rheumatology Care Center","Bellaire","77401",{"lat":321,"lon":322},29.70579,-95.45883,{"facility":324,"city":325,"state":311,"zip":326,"country":55,"geoPoint":327},"AARA Clinical Research\u002FLone Star Arthritis and Rheumatology","Fort Worth","76109",{"lat":328,"lon":329},32.72541,-97.32085,{"facility":331,"city":332,"state":311,"zip":333,"country":55,"geoPoint":334},"Accurate Clinical Research","Houston","77089",{"lat":335,"lon":336},29.76328,-95.36327,{"facility":338,"city":339,"state":311,"zip":340,"country":55,"geoPoint":341},"Advanced Rheumatology of Houston","The Woodlands","77382",{"lat":342,"lon":343},30.15799,-95.48938,{"facility":345,"city":346,"state":347,"zip":348,"country":55,"geoPoint":349},"Overlake Arthritis and Osteoporosis Center","Bellevue","Washington","98004",{"lat":350,"lon":351},47.61038,-122.20068,{"facility":353,"city":354,"state":347,"zip":355,"country":55,"geoPoint":356},"Arthritis Northwest","Spokane","99204",{"lat":357,"lon":358},47.65966,-117.42908,[],[361],{"name":362,"affiliation":363,"role":364},"Diana Abdueva","CEO","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":368,"biomarkers":369},[18],[],{"nct_id":4,"found":14,"summary":21,"prompt_version":21}]