Nctid:
NCT06611696
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D014657", "term"=>"Vasculitis"}, {"id"=>"D056648", "term"=>"Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis"}], "ancestors"=>[{"id"=>"D014652", "term"=>"Vascular Diseases"}, {"id"=>"D002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D056647", "term"=>"Systemic Vasculitis"}, {"id"=>"D017445", "term"=>"Skin Diseases, Vascular"}, {"id"=>"D012871", "term"=>"Skin Diseases"}, {"id"=>"D001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M17405", "name"=>"Vasculitis", "asFound"=>"Vasculitis", "relevance"=>"HIGH"}, {"id"=>"M28527", "name"=>"Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis", "asFound"=>"ANCA Associated Vasculitis", "relevance"=>"HIGH"}, {"id"=>"M28526", "name"=>"Systemic Vasculitis", "relevance"=>"LOW"}, {"id"=>"M17630", "name"=>"Granulomatosis with Polyangiitis", "relevance"=>"LOW"}, {"id"=>"M28400", "name"=>"Microscopic Polyangiitis", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M19714", "name"=>"Skin Diseases, Vascular", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"T375", "name"=>"ANCA-associated Vasculitis", "asFound"=>"ANCA Associated Vasculitis", "relevance"=>"HIGH"}, {"id"=>"T2610", "name"=>"Granulomatosis With Polyangiitis", "relevance"=>"LOW"}, {"id"=>"T3807", "name"=>"Microscopic Polyangiitis", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D011239", "term"=>"Prednisolone"}, {"id"=>"D000077555", "term"=>"Methylprednisolone Acetate"}, {"id"=>"D008775", "term"=>"Methylprednisolone"}, {"id"=>"D008776", "term"=>"Methylprednisolone Hemisuccinate"}, {"id"=>"C009935", "term"=>"Prednisolone acetate"}, {"id"=>"D000069283", "term"=>"Rituximab"}, {"id"=>"C021322", "term"=>"Prednisolone hemisuccinate"}, {"id"=>"C009022", "term"=>"Prednisolone phosphate"}], "ancestors"=>[{"id"=>"D000074322", "term"=>"Antineoplastic Agents, Immunological"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D005938", "term"=>"Glucocorticoids"}, {"id"=>"D006728", "term"=>"Hormones"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000932", "term"=>"Antiemetics"}, {"id"=>"D001337", "term"=>"Autonomic Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D005765", "term"=>"Gastrointestinal Agents"}, {"id"=>"D018696", "term"=>"Neuroprotective Agents"}, {"id"=>"D020011", "term"=>"Protective Agents"}], "browseLeaves"=>[{"id"=>"M373", "name"=>"Rituximab", "asFound"=>"Pain", "relevance"=>"HIGH"}, {"id"=>"M11749", "name"=>"Methylprednisolone", "asFound"=>"Determined", "relevance"=>"HIGH"}, {"id"=>"M1833", "name"=>"Methylprednisolone Acetate", "asFound"=>"Determined", "relevance"=>"HIGH"}, {"id"=>"M11750", "name"=>"Methylprednisolone Hemisuccinate", "asFound"=>"Determined", "relevance"=>"HIGH"}, {"id"=>"M14120", "name"=>"Prednisolone", "asFound"=>"Determined", "relevance"=>"HIGH"}, {"id"=>"M229449", "name"=>"Prednisolone acetate", "asFound"=>"Determined", "relevance"=>"HIGH"}, {"id"=>"M211887", "name"=>"Prednisolone hemisuccinate", "asFound"=>"Determined", "relevance"=>"HIGH"}, {"id"=>"M248881", "name"=>"Prednisolone phosphate", "asFound"=>"Determined", "relevance"=>"HIGH"}, {"id"=>"M9047", "name"=>"Glucocorticoids", "relevance"=>"LOW"}, {"id"=>"M16759", "name"=>"Tin Fluorides", "relevance"=>"LOW"}, {"id"=>"M1346", "name"=>"Antineoplastic Agents, Immunological", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M4251", "name"=>"Antiemetics", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}, {"id"=>"M20773", "name"=>"Neuroprotective Agents", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Neuroprotective Agents", "abbrev"=>"NeuroAg"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>160}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-11-15", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-11", "completionDateStruct"=>{"date"=>"2028-09-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-11-02", "studyFirstSubmitDate"=>"2024-09-22", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-11-05", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-03-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Proportions of patients achieving remission", "timeFrame"=>"26 weeks", "description"=>"Remission is defined as BVAS (Birmingham vasculitis activity score)=0 and less than 5mg/day of prednisolone."}], "secondaryOutcomes"=>[{"measure"=>"Sustained remission without taking prednisolone at 104 weeks", "timeFrame"=>"104 weeks", "description"=>"Remission is defined as BVAS (Birmingham vasculitis activity score)=0 and less than 5mg/day of prednisolone."}, {"measure"=>"Survival, relapse and end-stage renal disease", "timeFrame"=>"26 and 104 weeks", "description"=>"Assessed by Kaplan-Meier curves."}, {"measure"=>"Accumulative dose of glucocorticoids", "timeFrame"=>"26 and 104 weeks", "description"=>"Accumulative dose of glucocorticoids during the study period"}, {"measure"=>"Birmingham Vasculitis Activity Score (BVAS) version 3", "timeFrame"=>"26 and 104 weeks", "description"=>"BVAS is a scoring system for assessing the disease activity of vasculitis."}, {"measure"=>"Vasculitis Damage Index (VDI)", "timeFrame"=>"104 weeks", "description"=>"VDI is a scoring system for assessing irreversible disease damage due to vasculitis."}, {"measure"=>"Short-Form 36 (SF-36)", "timeFrame"=>"26 and 104 weeks", "description"=>"SF-36 is a scoring system for assessing patient QOL."}, {"measure"=>"Serious adverse event (SAE)", "timeFrame"=>"26 and 104 weeks", "description"=>"Event numbers and proportions of patients with one or more SAEs."}, {"measure"=>"Proportions of the patients with new onset diabetes mellitus", "timeFrame"=>"26 and 104 weeks", "description"=>"Diabetes mellitus requiring drug treatments"}, {"measure"=>"Proportions of the patients with new onset hypertension", "timeFrame"=>"26 and 104 weeks", "description"=>"Hypertension requiring drug treatments"}, {"measure"=>"Proportions of the patients with new onset hyperlipidemia", "timeFrame"=>"26 and 104 weeks", "description"=>"Hyperlipidemia requiring drug treatments"}, {"measure"=>"Proportion of the patients with new onset bone fracture, bone density", "timeFrame"=>"104 weeks", "description"=>"Bone density is assessed at lumber spines."}, {"measure"=>"Number of infections, proportions of the patients with infection", "timeFrame"=>"26 and 104 weeks", "description"=>"Infections requiring drug treatments"}, {"measure"=>"Number of serious infections, proportions of the patients with serious infection", "timeFrame"=>"26 and 104 weeks", "description"=>"Serious infections are serious events among infections requiring drug treatments."}, {"measure"=>"Proportions of the patients with liver dysfunction", "timeFrame"=>"26 and 104 weeks", "description"=>"Liver dysfunction \\>= grade 3 liver dysfunction (CTCAE)"}, {"measure"=>"Proportions of the patients with new onset malignancies", "timeFrame"=>"26 and 104 weeks", "description"=>"Malignancies diagnosed after the trial entry"}, {"measure"=>"Proportions of patients achieving remission without the rescue therapy", "timeFrame"=>"26 weeks", "description"=>"Remission is defined as BVAS (Birmingham vasculitis activity score)=0 and less than 5mg/day of prednisolone."}, {"measure"=>"Sustained remission without taking prednisolone at 104 weeks and the rescue therapy during the trial period", "timeFrame"=>"104 weeks", "description"=>"Remission is defined as BVAS (Birmingham vasculitis activity score)=0 and less than 5mg/day of prednisolone."}, {"measure"=>"Proportions of patients treated with the rescue therapy", "timeFrame"=>"26 and 104 weeks", "description"=>"Details of the rescue therapy are written in the section of \"Arms and Interventions\"."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["microscopic polyangiitis", "granulomatosis with polyangiitis", "avacopan", "ANCA-associated vasculitis"], "conditions"=>["ANCA Associated Vasculitis (AAV)"]}, "referencesModule"=>{"availIpds"=>[{"url"=>"https://www.m.chiba-u.jp/dept/allergy-clin-immunol/researcher/clinical/", "type"=>"Study Protocol", "comment"=>"Regarding deidentified patient data, please request to Dr Shunsuke Furuta at shfuruta@chiba-u.jp or Dr Masayoshi Harigai at mharigai@iuhw.ac.jp after publishing pre-defined trial results."}], "references"=>[{"pmid"=>"9041949", "type"=>"RESULT", "citation"=>"Exley AR, Bacon PA, Luqmani RA, Kitas GD, Gordon C, Savage CO, Adu D. Development and initial validation of the Vasculitis Damage Index for the standardized clinical assessment of damage in the systemic vasculitides. Arthritis Rheum. 1997 Feb;40(2):371-80. doi: 10.1002/art.1780400222."}, {"pmid"=>"19054820", "type"=>"RESULT", "citation"=>"Mukhtyar C, Lee R, Brown D, Carruthers D, Dasgupta B, Dubey S, Flossmann O, Hall C, Hollywood J, Jayne D, Jones R, Lanyon P, Muir A, Scott D, Young L, Luqmani RA. Modification and validation of the Birmingham Vasculitis Activity Score (version 3). Ann Rheum Dis. 2009 Dec;68(12):1827-32. doi: 10.1136/ard.2008.101279. Epub 2008 Dec 3."}, {"pmid"=>"35110332", "type"=>"RESULT", "citation"=>"Suppiah R, Robson JC, Grayson PC, Ponte C, Craven A, Khalid S, Judge A, Hutchings A, Merkel PA, Luqmani RA, Watts RA; DCVAS INVESTIGATORS. 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for microscopic polyangiitis. Ann Rheum Dis. 2022 Mar;81(3):321-326. doi: 10.1136/annrheumdis-2021-221796. Epub 2022 Feb 2."}, {"pmid"=>"35110333", "type"=>"RESULT", "citation"=>"Robson JC, Grayson PC, Ponte C, Suppiah R, Craven A, Judge A, Khalid S, Hutchings A, Watts RA, Merkel PA, Luqmani RA; DCVAS Investigators. 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for granulomatosis with polyangiitis. Ann Rheum Dis. 2022 Mar;81(3):315-320. doi: 10.1136/annrheumdis-2021-221795. Epub 2022 Feb 2."}, {"pmid"=>"36927642", "type"=>"RESULT", "citation"=>"Hellmich B, Sanchez-Alamo B, Schirmer JH, Berti A, Blockmans D, Cid MC, Holle JU, Hollinger N, Karadag O, Kronbichler A, Little MA, Luqmani RA, Mahr A, Merkel PA, Mohammad AJ, Monti S, Mukhtyar CB, Musial J, Price-Kuehne F, Segelmark M, Teng YKO, Terrier B, Tomasson G, Vaglio A, Vassilopoulos D, Verhoeven P, Jayne D. EULAR recommendations for the management of ANCA-associated vasculitis: 2022 update. Ann Rheum Dis. 2024 Jan 2;83(1):30-47. doi: 10.1136/ard-2022-223764."}, {"pmid"=>"34061144", "type"=>"RESULT", "citation"=>"Furuta S, Nakagomi D, Kobayashi Y, Hiraguri M, Sugiyama T, Amano K, Umibe T, Kono H, Kurasawa K, Kita Y, Matsumura R, Kaneko Y, Ninagawa K, Hiromura K, Kagami SI, Inaba Y, Hanaoka H, Ikeda K, Nakajima H; LoVAS Collaborators. Effect of Reduced-Dose vs High-Dose Glucocorticoids Added to Rituximab on Remission Induction in ANCA-Associated Vasculitis: A Randomized Clinical Trial. JAMA. 2021 Jun 1;325(21):2178-2187. doi: 10.1001/jama.2021.6615."}, {"pmid"=>"33596356", "type"=>"RESULT", "citation"=>"Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the Treatment of ANCA-Associated Vasculitis. N Engl J Med. 2021 Feb 18;384(7):599-609. doi: 10.1056/NEJMoa2023386. Erratum In: N Engl J Med. 2024 Jan 25;390(4):388. doi: 10.1056/NEJMx230010."}, {"pmid"=>"23045170", "type"=>"RESULT", "citation"=>"Jennette JC, Falk RJ, Bacon PA, Basu N, Cid MC, Ferrario F, Flores-Suarez LF, Gross WL, Guillevin L, Hagen EC, Hoffman GS, Jayne DR, Kallenberg CG, Lamprecht P, Langford CA, Luqmani RA, Mahr AD, Matteson EL, Merkel PA, Ozen S, Pusey CD, Rasmussen N, Rees AJ, Scott DG, Specks U, Stone JH, Takahashi K, Watts RA. 2012 revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides. Arthritis Rheum. 2013 Jan;65(1):1-11. doi: 10.1002/art.37715. No abstract available."}], "seeAlsoLinks"=>[{"url"=>"https://www.m.chiba-u.jp/dept/allergy-clin-immunol/researcher/clinical/", "label"=>"English version of the protocol is now preparing and will be shown in the above website."}]}, "descriptionModule"=>{"briefSummary"=>"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/relapse), 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.", "detailedDescription"=>"Anti-neutrophil cytoplasm antibody (ANCA)-associated vasculitis is characterized by a small to medium-size vasculitis and the presence of ANCA. ANCA-associated vasculitis includes microscopic polyangiitis, granulomatosis with polyangiitis and eosinophilic granulomatosis with polyangiitis. ANCA-associated vasculitis can be a life-threatening disease and the mortality is 80% at 1 year in untreated patients. In 2010s, standard therapies for remission induction of ANCA-associated vasculitis were the combination of high-dose glucocorticoids and either cyclophosphamide or rituximab. Although those therapies have high remission rates of 80-90%, mortality at 5 years is still high at 10-20% mainly due to treatments-related adverse events.\n\nIn the LoVAS trial (2021, JAMA), the combination of reduced-dose glucocorticoid and rituximab showed non-inferiority to high-dose glucocorticoid and rituximab in remission rates at 6 months. In addition, adverse events were dramatically less in the reduced-dose group than in the high-dose group.\n\nIn the ADVOCATE trial (2021, NEJM), the combination of avacopan, newly developed complement C5a inhibitor, and rituximab or cyclophosphamide showed non-inferiority to high-dose glucocorticoid and rituximab or cyclophosphamide in remission rates at 6 months. The avacopan group was allowed to use glucocorticoid within 1 month from the trial entry, and over 80% of patients used glucocorticoid indeed. Regarding adverse events, they were less in the avacopan group than in the glucocorticoid group.\n\nAlthough both the reduced-dose glucocorticoid regimen in the LoVAS trial and the avacopan regimen in the ADVOCATE trial are effective and safe for patients with ANCA-associated vasculitis, there is no trial directly comparing both regimens at the moment. Thus, in this multicenter, open-label, randomized, non-ineriority, phase 4 trial, the investigators aim to investigate if the combination of avacoapn, short-term (4 weeks) reduced-dose glucocorticoid and rituximab is non-inferior to the combination of reduced-dose glucocorticoid (20 weeks) and rituximab. The investigators also compare safety profiles and disease relapse between the two groups. A total of 160 patients with new-onset ANCA-associated vasculitis (microscopic polyangiitis and granulomatosis with polyangiitis) will be recruited and randomized to the two treatments groups. The primary end point is remission rate at 26 weeks, and the patients will be followed until 104 weeks for assessing disease relapse and long-term safety."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"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/ACR 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/min) or alveolar hemorrhage (oxygen inhalation more than 2L/min)\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"}, "identificationModule"=>{"nctId"=>"NCT06611696", "acronym"=>"ARRIA", "briefTitle"=>"Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis", "organization"=>{"class"=>"OTHER", "fullName"=>"Chiba University"}, "officialTitle"=>"Avacopan With Short-term Reduced-dose Glucocorticoids vs Reduced-dose Glucocorticoids Added to Rituximab on Remission Induction in ANCA-associated Vasculitis", "orgStudyIdInfo"=>{"id"=>"CRB0097-24"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Glucocorticoid group", "description"=>"Prednisolone will be commenced with dose of 0.5mg/kg/day 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/day of prednisolone and postpone the procedure of stopping prednisolone. Patients will also receive rituximab (375mg/m2/w x4).\n\nDuring remission maintenance phase (6-24 months),, patients will receive rituximab (500mg/body) 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/day (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/day (less than 2 weeks) can be allowed as the rescue therapy. Minor relapse is defined as relapse with no major BVAS item.", "interventionNames"=>["Drug: Prednisolone and rituximab"]}, {"type"=>"EXPERIMENTAL", "label"=>"Avacopan group", "description"=>"Prednisolone will be commenced with dose of 0.5mg/kg/day and will be tapered and off within 1 months. Patients will also receive avacopan (60mg/day) and rituximab (375mg/m2/w x4).\n\nDuring remission maintenance phase (6-24 months), patients will receive avacopan (60mg/day) 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/day (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/day (less than 2 weeks) can be allowed as the rescue therapy. Minor relapse is defined as relapse with no major BVAS item.", "interventionNames"=>["Drug: Avacopan, prednisolone and rituximab"]}], "interventions"=>[{"name"=>"Avacopan, prednisolone and rituximab", "type"=>"DRUG", "description"=>"Patients in the avacoapn group will be treated with avacoapn, short-term reduced-dose prednisolone and rituximab.", "armGroupLabels"=>["Avacopan group"]}, {"name"=>"Prednisolone and rituximab", "type"=>"DRUG", "description"=>"Patients in the glucocorticoid arm will be treated with reduced-dose prednisolone and rituximab.", "armGroupLabels"=>["Glucocorticoid group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"4701192", "city"=>"Toyoake", "state"=>"Aichi", "country"=>"Japan", "contacts"=>[{"name"=>"Naotake Tsuboi, MD, PhD", "role"=>"CONTACT", "email"=>"nao-take@fujita-hu.ac.jp", "phone"=>"81+0562-93-2111"}], "facility"=>"Fujita Health University Hospital", "geoPoint"=>{"lat"=>35.038, "lon"=>136.99931}}, {"zip"=>"2892511", "city"=>"Asahi", "state"=>"Chiba", "country"=>"Japan", "contacts"=>[{"name"=>"ShinIchiro Kagami, MD, PhD", "role"=>"CONTACT", "email"=>"kagami@hospital-asahi.jp", "phone"=>"81+0479-63-8111"}], "facility"=>"Asahi General Hospital", "geoPoint"=>{"lat"=>35.71667, "lon"=>140.65}}, {"zip"=>"2900003", "city"=>"Ichihara", "state"=>"Chiba", "country"=>"Japan", "contacts"=>[{"name"=>"Tomohiro Tamachi, MD, PhD", "role"=>"CONTACT", "email"=>"tamachit@chiba-u.jp", "phone"=>"81+0436-74-1111"}], "facility"=>"Chiba Rosai Hospital", "geoPoint"=>{"lat"=>35.51667, "lon"=>140.08333}}, {"zip"=>"2968602", "city"=>"Kamogawa", "state"=>"Chiba", "country"=>"Japan", "contacts"=>[{"name"=>"Tomo Suzuki, MD", "role"=>"CONTACT", "email"=>"suzuki.tomo@kameda.jp", "phone"=>"81+04-7092-2211"}], "facility"=>"Kameda Medical Centre", "geoPoint"=>{"lat"=>35.0969, "lon"=>140.1003}}, {"zip"=>"2868520", "city"=>"Narita", "state"=>"Chiba", "country"=>"Japan", "contacts"=>[{"name"=>"Masayoshi Harigai, MD, PhD", "role"=>"CONTACT", 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