[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559694":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":22,"studyPopulation":22,"armGroups":34,"interventions":57,"overallOfficials":68,"centralContacts":72,"locations":78,"responsibleParty":339,"collaborators":22,"id":341,"slug":22,"hasResults":342,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":342,"sex":348,"minAge":349,"maxAge":22,"enrollmentInfo":350,"targetDuration":22,"studyType":353,"phases":354,"briefSummary":356,"conditions":357,"keywords":22,"overallStatus":93,"whyStopped":22,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":368},{"fullName":5,"class":6},"Citryll BV","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"The change in DAS28-CRP at week 6 compared to baseline","Efficacy of CIT-013","week 6",[14,18],{"measure":15,"description":16,"timeFrame":17},"Incidence of TEAEs as assessed by CTCAE","Safety and tolerability of CIT-013","12 weeks",{"measure":19,"description":20,"timeFrame":21},"Maximum Plasma Concentration of CIT-013 before doses","CIT-013 levels","4, 6, 10 and 12 weeks",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":29},"QUADRUPLE",[30,31,32,33],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[35,41,46,52],{"label":36,"type":37,"description":38,"interventionNames":39},"CIT-013 low dose","EXPERIMENTAL","3 SC injections with low dose CIT-013 and 3 SC injections with medium dose CIT-013",[40],"Drug: CIT-013 low dose",{"label":42,"type":37,"description":43,"interventionNames":44},"CIT-013 high dose","3 SC injections with CIT-013 high dose and 3 SC injections with CIT-013 medium dose",[45],"Drug: CIT-013 high dose",{"label":47,"type":48,"description":49,"interventionNames":50},"Placebo","PLACEBO_COMPARATOR","3 SC injections with placebo and 3 SC injections with CIT-013 medium dose",[51],"Drug: Placebo",{"label":53,"type":37,"description":54,"interventionNames":55},"CIT-013 medium dose","6 SC injections with CIT-013 medium dose",[56],"Drug: CIT-013 medium dose",[58,62,64,66],{"type":59,"name":36,"description":60,"armGroupLabels":61,"otherNames":22},"DRUG","Subcutaneous injection",[36],{"type":59,"name":42,"description":60,"armGroupLabels":63,"otherNames":22},[42],{"type":59,"name":47,"description":60,"armGroupLabels":65,"otherNames":22},[47],{"type":59,"name":53,"description":53,"armGroupLabels":67,"otherNames":22},[53],[69],{"name":70,"affiliation":5,"role":71},"Maarten Kraan","STUDY_DIRECTOR",[73],{"name":74,"role":75,"phone":76,"phoneExt":22,"email":77},"Leonie Middelink","CONTACT","0613328444","lmiddelink@citryll.com",[79,91,103,116,127,138,146,154,164,175,183,195,206,219,230,241,252,263,274,287,298,306,317,328],{"facility":80,"status":81,"city":82,"state":22,"zip":22,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":22},"BE-02","WITHDRAWN","Antwerp","Belgium","BE",{"type":86,"coordinates":87},"Point",[88,89],4.40026,51.22047,{"lat":89,"lon":88},{"facility":92,"status":93,"city":94,"state":22,"zip":22,"country":83,"countryCode":84,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Site BE-01","RECRUITING","Leuven",{"type":86,"coordinates":96},[97,98],4.70093,50.87959,{"lat":98,"lon":97},[101],{"name":102,"role":75,"phone":22,"phoneExt":22,"email":22},"PI BE-01",{"facility":104,"status":93,"city":105,"state":22,"zip":22,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"DE-04","Bamberg","Germany","DE",{"type":86,"coordinates":109},[110,111],10.90067,49.89873,{"lat":111,"lon":110},[114],{"name":115,"role":75,"phone":22,"phoneExt":22,"email":22},"PI DE-04",{"facility":117,"status":93,"city":118,"state":22,"zip":22,"country":106,"countryCode":107,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"DE-05","Berlin",{"type":86,"coordinates":120},[121,122],13.41053,52.52437,{"lat":122,"lon":121},[125],{"name":126,"role":75,"phone":22,"phoneExt":22,"email":22},"PI DE-05",{"facility":128,"status":93,"city":129,"state":22,"zip":22,"country":106,"countryCode":107,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"DE-01","München",{"type":86,"coordinates":131},[132,133],13.31243,51.60698,{"lat":133,"lon":132},[136],{"name":137,"role":75,"phone":22,"phoneExt":22,"email":22},"PI DE-01",{"facility":139,"status":93,"city":129,"state":22,"zip":22,"country":106,"countryCode":107,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},"DE-02",{"type":86,"coordinates":141},[132,133],{"lat":133,"lon":132},[144],{"name":145,"role":75,"phone":22,"phoneExt":22,"email":22},"PI DE-02",{"facility":147,"status":81,"city":148,"state":22,"zip":22,"country":106,"countryCode":107,"cosmosGeoPoint":149,"geoPoint":153,"contacts":22},"DE-03","Ratingen",{"type":86,"coordinates":150},[151,152],6.84929,51.29724,{"lat":152,"lon":151},{"facility":155,"status":81,"city":156,"state":22,"zip":22,"country":157,"countryCode":158,"cosmosGeoPoint":159,"geoPoint":163,"contacts":22},"NL-02","Amsterdam","Netherlands","NL",{"type":86,"coordinates":160},[161,162],4.88969,52.37403,{"lat":162,"lon":161},{"facility":165,"status":93,"city":166,"state":22,"zip":22,"country":157,"countryCode":158,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"NL-05","Leeuwarden",{"type":86,"coordinates":168},[169,170],5.80973,53.20271,{"lat":170,"lon":169},[173],{"name":174,"role":75,"phone":22,"phoneExt":22,"email":22},"PI NL-05",{"facility":176,"status":81,"city":177,"state":22,"zip":22,"country":157,"countryCode":158,"cosmosGeoPoint":178,"geoPoint":182,"contacts":22},"NL-04","Leiden",{"type":86,"coordinates":179},[180,181],4.49306,52.15833,{"lat":181,"lon":180},{"facility":184,"status":185,"city":186,"state":22,"zip":22,"country":157,"countryCode":158,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"NL-03","NOT_YET_RECRUITING","Nijmegen",{"type":86,"coordinates":188},[189,190],5.85278,51.8425,{"lat":190,"lon":189},[193],{"name":194,"role":75,"phone":22,"phoneExt":22,"email":22},"PI NL-03",{"facility":196,"status":93,"city":197,"state":22,"zip":22,"country":157,"countryCode":158,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"NL-01","Rotterdam",{"type":86,"coordinates":199},[200,201],4.47917,51.9225,{"lat":201,"lon":200},[204],{"name":205,"role":75,"phone":22,"phoneExt":22,"email":22},"PI NL-01",{"facility":207,"status":93,"city":208,"state":22,"zip":22,"country":209,"countryCode":210,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"PL-01","Bialystok","Poland","PL",{"type":86,"coordinates":212},[213,214],23.16433,53.13333,{"lat":214,"lon":213},[217],{"name":218,"role":75,"phone":22,"phoneExt":22,"email":22},"PI PL-01",{"facility":220,"status":93,"city":221,"state":22,"zip":22,"country":209,"countryCode":210,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"PL-07","Krakow",{"type":86,"coordinates":223},[224,225],19.93658,50.06143,{"lat":225,"lon":224},[228],{"name":229,"role":75,"phone":22,"phoneExt":22,"email":22},"PI PL-07",{"facility":231,"status":93,"city":232,"state":22,"zip":22,"country":209,"countryCode":210,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"PL-03","Lublin",{"type":86,"coordinates":234},[235,236],22.57009,51.25058,{"lat":236,"lon":235},[239],{"name":240,"role":75,"phone":22,"phoneExt":22,"email":22},"PI PL-03",{"facility":242,"status":93,"city":243,"state":22,"zip":22,"country":209,"countryCode":210,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"PL-02","Poznan",{"type":86,"coordinates":245},[246,247],16.92993,52.40692,{"lat":247,"lon":246},[250],{"name":251,"role":75,"phone":22,"phoneExt":22,"email":22},"PI PL-02",{"facility":253,"status":93,"city":254,"state":22,"zip":22,"country":209,"countryCode":210,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"PL-05","Torun",{"type":86,"coordinates":256},[257,258],18.59814,53.01375,{"lat":258,"lon":257},[261],{"name":262,"role":75,"phone":22,"phoneExt":22,"email":22},"PI PL-05",{"facility":264,"status":93,"city":265,"state":22,"zip":22,"country":209,"countryCode":210,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"PL-04","Warsaw",{"type":86,"coordinates":267},[268,269],21.01178,52.22977,{"lat":269,"lon":268},[272],{"name":273,"role":75,"phone":22,"phoneExt":22,"email":22},"PI PL-04",{"facility":275,"status":93,"city":276,"state":22,"zip":22,"country":277,"countryCode":278,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"ES-02","A Coruña","Spain","ES",{"type":86,"coordinates":280},[281,282],-8.396,43.37135,{"lat":282,"lon":281},[285],{"name":286,"role":75,"phone":22,"phoneExt":22,"email":22},"PI ES-02",{"facility":288,"status":93,"city":289,"state":22,"zip":22,"country":277,"countryCode":278,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"ES-04","Barcelona",{"type":86,"coordinates":291},[292,293],2.15899,41.38879,{"lat":293,"lon":292},[296],{"name":297,"role":75,"phone":22,"phoneExt":22,"email":22},"PI ES-04",{"facility":299,"status":93,"city":289,"state":22,"zip":22,"country":277,"countryCode":278,"cosmosGeoPoint":300,"geoPoint":302,"contacts":303},"ES-05",{"type":86,"coordinates":301},[292,293],{"lat":293,"lon":292},[304],{"name":305,"role":75,"phone":22,"phoneExt":22,"email":22},"PI ES-05",{"facility":307,"status":93,"city":308,"state":22,"zip":22,"country":277,"countryCode":278,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"ES-06","Madrid",{"type":86,"coordinates":310},[311,312],-3.70256,40.4165,{"lat":312,"lon":311},[315],{"name":316,"role":75,"phone":22,"phoneExt":22,"email":22},"PI ES-06",{"facility":318,"status":93,"city":319,"state":22,"zip":22,"country":277,"countryCode":278,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"ES-01","Santander",{"type":86,"coordinates":321},[322,323],-3.80493,43.46589,{"lat":323,"lon":322},[326],{"name":327,"role":75,"phone":22,"phoneExt":22,"email":22},"PI ES-01",{"facility":329,"status":93,"city":330,"state":22,"zip":22,"country":277,"countryCode":278,"cosmosGeoPoint":331,"geoPoint":335,"contacts":336},"ES-03","Santiago de Compostela",{"type":86,"coordinates":332},[333,334],-8.54569,42.88052,{"lat":334,"lon":333},[337],{"name":338,"role":75,"phone":22,"phoneExt":22,"email":22},"PI ES-03",{"type":340,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100559694",false,"NCT06567470","A Study With CIT-013 in RA Patients","A Phase IIa Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Trial To Investigate The Effects Of Three Dose Levels Of CIT-013 On Disease Activity In Patients With Moderately Active Rheumatoid Arthritis.","Citydream","Inclusion Criteria:\n\n* Male or female patients with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 3 months prior to screening\n* Aged 18-85\n* DAS28-CRP ≥ 3.2, with ≥ 3 Swollen Joints, and ≥ 3 Tender Joints, and CRP ≥ ULN at screening and confirmed prior to randomization\n* Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months.\n\nExclusion Criteria:\n\n* High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).\n* Contra-indication for CIT-013\n* Current inflammatory joint disease other than RA (Sjogren with active disease is included).\n* The washout period for bDMARD or JAKi prior to the first dose of investigational product should be at least:\n\n  1. ≥ 1 week for etanercept;\n  2. ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab;\n  3. ≥ 6 months year for rituximab;\n  4. ≥ 2 weeks for tsDMARD (either investigational or commercially available treatment).\n* Treated with ≥ 3 bDMARD or tsDMARD\n* Injectable corticosteroids or treatment with \\> 10 mg\u002Fday dose of oral prednisolone or equivalent within 4 weeks prior to screening.","ALL","18 Years",{"count":351,"type":352},88,"ESTIMATED","INTERVENTIONAL",[355],"PHASE2","The goal of this clinical trial is to learn if CIT-013 works to treat rheumatoid arthritis in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are:\n\nDoes CIT-013 lower the disease activity of RA patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of RA.\n\nParticipants will:\n\nTake receive CIT-013 or placebo every other week for 6 weeks and 50 mg CIT-013 for 6 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period",[358],"Rheumatoid Arthritis","2026-05-20",{"date":361,"type":362},"2026-05-22","ACTUAL",{"date":364,"type":362},"2025-07-29",{"date":366,"type":352},"2027-07",{"name":5,"class":6},24]