[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563094":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":43,"responsibleParty":346,"collaborators":349,"id":354,"slug":355,"hasResults":356,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":356,"sex":362,"minAge":363,"maxAge":26,"enrollmentInfo":364,"targetDuration":26,"studyType":367,"phases":368,"briefSummary":370,"conditions":371,"keywords":373,"overallStatus":65,"whyStopped":26,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":387},{"fullName":5,"class":6},"Chiba University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Glucocorticoid group","ACTIVE_COMPARATOR","Prednisolone will be commenced with dose of 0.5mg\u002Fkg\u002Fday and will be tapered and off within 5 months. If a patient fails to achieve BVAS=0 or normalization of CRP levels or normalization of ANCA levels, an investigator can keep 5mg\u002Fday of prednisolone and postpone the procedure of stopping prednisolone. Patients will also receive rituximab (375mg\u002Fm2\u002Fw x4).\n\nDuring remission maintenance phase (6-24 months),, patients will receive rituximab (500mg\u002Fbody) every 6 months as remission maintenance therapy.\n\nIn the case of inadequate response to the combination therapy of prednisolone and rituximab, additional administration of prednisolone 20mg\u002Fday (less than 2 weeks) can be allowed as the rescue therapy.\n\nDuring remission maintenance phase, in the case of minor relapse, additional administration of prednisolone 20mg\u002Fday (less than 2 weeks) can be allowed as the rescue therapy. Minor relapse is defined as relapse with no major BVAS item.",[13],"Drug: Prednisolone and rituximab",{"label":15,"type":16,"description":17,"interventionNames":18},"Avacopan group","EXPERIMENTAL","Prednisolone will be commenced with dose of 0.5mg\u002Fkg\u002Fday and will be tapered and off within 1 months. Patients will also receive avacopan (60mg\u002Fday) and rituximab (375mg\u002Fm2\u002Fw x4).\n\nDuring remission maintenance phase (6-24 months), patients will receive avacopan (60mg\u002Fday) as remission maintenance therapy until the trial end.\n\nIn the case of inadequate response to the combination therapy of avacopan, prednisolone and rituximab, additional administration of prednisolone 20mg\u002Fday (less than 2 weeks) can be allowed as the rescue therapy.\n\nDuring remission maintenance phase, in the case of minor relapse, additional administration of prednisolone 20mg\u002Fday (less than 2 weeks) can be allowed as the rescue therapy. Minor relapse is defined as relapse with no major BVAS item.",[19],"Drug: Avacopan, prednisolone and rituximab",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Avacopan, prednisolone and rituximab","Patients in the avacoapn group will be treated with avacoapn, short-term reduced-dose prednisolone and rituximab.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Prednisolone and rituximab","Patients in the glucocorticoid arm will be treated with reduced-dose prednisolone and rituximab.",[9],[32],{"name":33,"affiliation":34,"role":35},"Masayoshi Harigai, MD, PhD","International University of Health and Welfare","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Shunsuke Furuta, MD, PhD","CONTACT","81+43-222-7171","5531","shfuruta@chiba-u.jp",[44,63,79,92,100,114,128,140,151,166,181,196,211,225,240,254,269,284,294,308,322,336],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Fujita Health University Hospital","NOT_YET_RECRUITING","Toyoake","Aichi-ken","4701192","Japan","JP",{"type":53,"coordinates":54},"Point",[55,56],136.99931,35.038,{"lat":56,"lon":55},[59],{"name":60,"role":39,"phone":61,"phoneExt":26,"email":62},"Naotake Tsuboi, MD, PhD","81+0562-93-2111","nao-take@fujita-hu.ac.jp",{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":50,"countryCode":51,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Asahi General Hospital","RECRUITING","Asahi","Chiba","2892511",{"type":53,"coordinates":70},[71,72],140.65,35.71667,{"lat":72,"lon":71},[75],{"name":76,"role":39,"phone":77,"phoneExt":26,"email":78},"ShinIchiro Kagami, MD, PhD","81+0479-63-8111","kagami@hospital-asahi.jp",{"facility":80,"status":65,"city":67,"state":67,"zip":81,"country":50,"countryCode":51,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Chiba Aoba Municipal Hospital","2600852",{"type":53,"coordinates":83},[84,85],140.11667,35.6,{"lat":85,"lon":84},[88],{"name":89,"role":39,"phone":90,"phoneExt":26,"email":91},"Yoshihisa Kobayashi, MD, PhD","81+043-227-1131","yoshikoba7923@yahoo.co.jp",{"facility":5,"status":65,"city":67,"state":67,"zip":93,"country":50,"countryCode":51,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},"2608677",{"type":53,"coordinates":95},[84,85],{"lat":85,"lon":84},[98],{"name":38,"role":39,"phone":99,"phoneExt":41,"email":42},"81+432227171",{"facility":101,"status":65,"city":102,"state":67,"zip":103,"country":50,"countryCode":51,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Chiba Rosai Hospital","Ichihara","2900003",{"type":53,"coordinates":105},[106,107],140.08333,35.51667,{"lat":107,"lon":106},[110],{"name":111,"role":39,"phone":112,"phoneExt":26,"email":113},"Tomohiro Tamachi, MD, PhD","81+0436-74-1111","tamachit@chiba-u.jp",{"facility":115,"status":65,"city":116,"state":67,"zip":117,"country":50,"countryCode":51,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Kameda Medical Centre","Kamogawa","2968602",{"type":53,"coordinates":119},[120,121],140.1003,35.0969,{"lat":121,"lon":120},[124],{"name":125,"role":39,"phone":126,"phoneExt":26,"email":127},"Tomo Suzuki, MD","81+04-7092-2211","suzuki.tomo@kameda.jp",{"facility":34,"status":65,"city":129,"state":67,"zip":130,"country":50,"countryCode":51,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Narita","2868520",{"type":53,"coordinates":132},[133,134],140.31667,35.78333,{"lat":134,"lon":133},[137],{"name":33,"role":39,"phone":138,"phoneExt":26,"email":139},"81+0476-35-5600","mharigai@iuhw.ac.jp",{"facility":141,"status":65,"city":129,"state":67,"zip":142,"country":50,"countryCode":51,"cosmosGeoPoint":143,"geoPoint":145,"contacts":146},"Japanese Red Cross Narita Hospital","2868523",{"type":53,"coordinates":144},[133,134],{"lat":134,"lon":133},[147],{"name":148,"role":39,"phone":149,"phoneExt":26,"email":150},"Masaki Hiraguri, MD","81+0476-22-2311","hiraguri@naritasekijyuji.jp",{"facility":152,"status":65,"city":153,"state":154,"zip":155,"country":50,"countryCode":51,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Gunma University","Maebashi","Gunma","3718511",{"type":53,"coordinates":157},[158,159],139.08333,36.4,{"lat":159,"lon":158},[162],{"name":163,"role":39,"phone":164,"phoneExt":26,"email":165},"Keijyu Hiromura, MD, PhD","81+027-220-7111","hiromura@gunma-u.ac.jp",{"facility":167,"status":65,"city":168,"state":169,"zip":170,"country":50,"countryCode":51,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Kagawa University","Hiragi","Kagawa-ken","7610793",{"type":53,"coordinates":172},[173,174],134.13074,34.2706,{"lat":174,"lon":173},[177],{"name":178,"role":39,"phone":179,"phoneExt":26,"email":180},"Hiroaki Dobashi, MD, PhD","81+087-898-5111","dobashi.hiroaki@kagawa-u.ac.jp",{"facility":182,"status":65,"city":183,"state":184,"zip":185,"country":50,"countryCode":51,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"St.Marianna University School of Medicine","Kawasaki","Kanagawa","2168511",{"type":53,"coordinates":187},[188,189],139.71722,35.52056,{"lat":189,"lon":188},[192],{"name":193,"role":39,"phone":194,"phoneExt":26,"email":195},"Kimito Kawahata, MD, PhD","81+044-977-8111","kimito.kawahata@marianna-u.ac.jp",{"facility":197,"status":65,"city":198,"state":199,"zip":200,"country":50,"countryCode":51,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Tohoku Univerisity","Sendai","Miyagi","9808574",{"type":53,"coordinates":202},[203,204],140.86667,38.26667,{"lat":204,"lon":203},[207],{"name":208,"role":39,"phone":209,"phoneExt":26,"email":210},"Hiroshi Fujii, MD, PhD","81+022-717-7000","hfujii@med.tohoku.ac.jp",{"facility":212,"status":65,"city":213,"state":213,"zip":214,"country":50,"countryCode":51,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Nagasaki University","Nagasaki","8528501",{"type":53,"coordinates":216},[217,218],129.88333,32.75,{"lat":218,"lon":217},[221],{"name":222,"role":39,"phone":223,"phoneExt":26,"email":224},"Atsushi Kawakami, MD, PhD","81+095-819-7200","atsushik@nagasaki-u.ac.jp",{"facility":226,"status":65,"city":227,"state":228,"zip":229,"country":50,"countryCode":51,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"Okayama University","Okayama","Okayama-ken","7008558",{"type":53,"coordinates":231},[232,233],133.93333,34.65,{"lat":233,"lon":232},[236],{"name":237,"role":39,"phone":238,"phoneExt":26,"email":239},"Yoshinori Matsumoto, MD, PhD","81+086-235-7235","ymatsumoto@okayama-u.ac.jp",{"facility":241,"status":65,"city":242,"state":242,"zip":243,"country":50,"countryCode":51,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Kitano Hospital","Osaka","5308480",{"type":53,"coordinates":245},[246,247],135.50107,34.69379,{"lat":247,"lon":246},[250],{"name":251,"role":39,"phone":252,"phoneExt":26,"email":253},"Tomomi Endo, MD","81+06-6312-1221","t-endou1106@kitano-hp.or.jp",{"facility":255,"status":65,"city":256,"state":257,"zip":258,"country":50,"countryCode":51,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"Saitama Medical University","Kawagoe","Saitama","3508550",{"type":53,"coordinates":260},[261,262],139.48528,35.90861,{"lat":262,"lon":261},[265],{"name":266,"role":39,"phone":267,"phoneExt":26,"email":268},"Takahiko Kurasawa, MD, PhD","81+049-228-3574","t_kura@saitama-med.ac.jp",{"facility":270,"status":65,"city":271,"state":272,"zip":273,"country":50,"countryCode":51,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"Dokkyo Medical University","Mibu","Tochigi","3210293",{"type":53,"coordinates":275},[276,277],139.8,36.41667,{"lat":277,"lon":276},[280],{"name":281,"role":39,"phone":282,"phoneExt":26,"email":283},"Kei Ikeda, MD, PhD","81+0282-86-1111","k-ikeda847@dokkyomed.ac.jp",{"facility":285,"status":65,"city":286,"state":287,"zip":288,"country":50,"countryCode":51,"cosmosGeoPoint":26,"geoPoint":26,"contacts":289},"Juntendo Univeristy","Bunkyoku","Tokyo","1138431",[290],{"name":291,"role":39,"phone":292,"phoneExt":26,"email":293},"Naoto Tamura, MD, PhD","81+03-3813-3111","tnaoto@juntendo.ac.jp",{"facility":295,"status":65,"city":296,"state":287,"zip":297,"country":50,"countryCode":51,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"Kyorin University","Mitaka","1818611",{"type":53,"coordinates":299},[300,301],139.56002,35.68361,{"lat":301,"lon":300},[304],{"name":305,"role":39,"phone":306,"phoneExt":26,"email":307},"Yoshinori Komagata, MD, PhD","81+0422-47-5511","komagata@ks.kyorin-u.ac.jp",{"facility":309,"status":65,"city":310,"state":287,"zip":311,"country":50,"countryCode":51,"cosmosGeoPoint":312,"geoPoint":316,"contacts":317},"Toho University","Ōta-ku","1438541",{"type":53,"coordinates":313},[314,315],139.71605,35.56126,{"lat":315,"lon":314},[318],{"name":319,"role":39,"phone":320,"phoneExt":26,"email":321},"Toshihiro Nanki, MD, PhD","81+03-3762-4151","toshihiro.nanki@med.toho-u.ac.jp",{"facility":323,"status":65,"city":324,"state":287,"zip":325,"country":50,"countryCode":51,"cosmosGeoPoint":326,"geoPoint":330,"contacts":331},"Teikyo University","tabashi City","1738606",{"type":53,"coordinates":327},[328,329],139.71497,35.74893,{"lat":329,"lon":328},[332],{"name":333,"role":39,"phone":334,"phoneExt":26,"email":335},"Hajime Kono, MD, PhD","81+03-3964-1211","kono@med.teikyo-u.ac.jp",{"facility":337,"status":65,"city":338,"state":339,"zip":340,"country":50,"countryCode":51,"cosmosGeoPoint":26,"geoPoint":26,"contacts":341},"Yamanashi University","Chuo-shi","Yamanashi","4093898",[342],{"name":343,"role":39,"phone":344,"phoneExt":26,"email":345},"Daiki Nakagomi, MD, PhD","81+055-273-3113","dnakagomi@yamanashi.ac.jp",{"type":35,"investigatorFullName":347,"investigatorTitle":348,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Shunsuke Furuta","Associate Professor, Department of Allergy and Clinical Immunology",[350,353],{"name":351,"class":352},"Kissei Pharmaceutical Co., Ltd.","INDUSTRY",{"name":34,"class":6},"100563094","phase-4-avacopan-vs-reduced-dose-glucocorticoids-in-anca-associated-vasculitis-100563094",false,"NCT06611696","Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis","Avacopan With Short-term Reduced-dose Glucocorticoids vs Reduced-dose Glucocorticoids Added to Rituximab on Remission Induction in ANCA-associated Vasculitis","ARRIA","Inclusion Criteria:\n\n1. Provision of written informed consent by a patient or a surrogate decision maker\n2. Age=\\>18 years\n3. New clinical diagnosis of ANCA-associated vasculitis (granulomatosis with polyangiitis, microscopic polyangiitis) consistent with the 2012 Chapel Hill consensus definitions and 2022 EULAR\u002FACR classification criteria\n4. Positive test by ELISA, CLEIA or FEIA for proteinase 3-ANCA or myeloperoxidase-ANCA\n\nExclusion Criteria:\n\n1. Prior treatment for ANCA-associated vasculitis before trial entry\n2. ANCA-associated vasculitis related glomerulonephritis (eGFR less than 15ml\u002Fmin) or alveolar hemorrhage (oxygen inhalation more than 2L\u002Fmin)\n3. Presence of another multisystem autoimmune disease\n4. Known infection with HIV; a past or current history of hepatitis B virus or hepatitis C virus infection\n5. Desire to bear children, pregnancy or lactating\n6. History of malignancy within the past 5 years or any evidence of persistent malignancy\n7. Ongoing or recent (last 1 year) evidence of active tuberculosis\n8. History of severe allergy or anaphylaxis to monoclonal antibody therapy\n9. Any concomitant condition anticipated to likely require oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange or IVIg\n10. Any biological B cell depleting agent (such as rituximab or belimumab)-use within the past 6 months\n11. Past history of medication of avacopan\n12. Patients can not take avacopan and prednisolone orally\n13. Other conditions, in the investigator\\'s opinion, inappropriate for the trial entry","ALL","18 Years",{"count":365,"type":366},160,"ESTIMATED","INTERVENTIONAL",[369],"PHASE4","The goal of this clinical trial is to learn if avacopan in combination with short-term (4 weeks) reduced-dose glucocorticoid and rituximab works to treat patients with newly-onset ANCA-associated vasculitis. It will also learn about the long-term safety of avacopan. The main questions it aims to answer are:\n\nIs avacopan in combination with short-term reduced-dose glucocorticoid and rituximab as effective as the combination of 20 week reduced-dose glucocorticoid and rituximab in the proportion of the patients achieving remission? Does avacopan lower the relapse rate compared to the 6 monthly rituximab maintenance therapy? What medical problems do participants have when taking long-term avacopan?\n\nParticipants will:\n\nBe treated with avacopan in combination with short-term (until 4 weeks) reduced-dose glucocorticoid and rituximab (at 0 week) or reduced-dose glucocorticoid (until 20 weeks) and rituximab (at 0, 26, 52 and 78 weeks).\n\nBe assessed at 0, 4, 8, 16, 26, 52, 78 and 104 weeks regarding disease status (remission\u002Frelapse), disease activity by Birmingham Vasculitis Activity Score ver3, disease damage by Vasculitis Damage Index and adverse events.\n\nThe primary endpoint is remission rates at 26 weeks.",[372],"ANCA Associated Vasculitis (AAV)",[374,375,376,377],"microscopic polyangiitis","granulomatosis with polyangiitis","avacopan","ANCA-associated vasculitis","2025-05-01",{"date":380,"type":381},"2025-05-04","ACTUAL",{"date":383,"type":381},"2024-11-15",{"date":385,"type":366},"2028-09-30",{"name":5,"class":6},22]