[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524740":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":42,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":24,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tofactinib","EXPERIMENTAL","Patients receive Tofacitinib and Naproxene",[13],"Drug: Tofacitinib 5 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Arm","ACTIVE_COMPARATOR","Patients receive placebo pills and Naproxene",[13],[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","Tofacitinib 5 MG",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Denis Poddubbnyy, Prof. Dr. med.","Charité Rheumatology","PRINCIPAL_INVESTIGATOR",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Hildrun Haibel, PD Dr. med.","CONTACT","+49308445","4414","hildrun.haibel@charite.de",{"name":38,"role":33,"phone":39,"phoneExt":40,"email":41},"Valeria Rios-Rodriguez, Dr. med.","+30450","543640","valeria.rios-rodriguez@charite.de",[43],{"facility":44,"status":45,"city":46,"state":24,"zip":24,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Charité Universitätsmedizin Berlin","RECRUITING","Berlin","Germany","DE",{"type":50,"coordinates":51},"Point",[52,53],13.41053,52.52437,{"lat":53,"lon":52},[56],{"name":57,"role":33,"phone":58,"phoneExt":24,"email":41},"Dr. Valeria Rios Rodriguez","004930450514582",{"type":29,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Denis Poddubnyy","Prof. Dr. med.",[63],{"name":64,"class":65},"Pfizer","INDUSTRY","100524740","phase-4-tofacitinib-in-early-active-axial-spondyloarthritis-100524740",false,"NCT06112665","ToFAcitinib in Early Active Axial SpondyloarThritis:","ToFAcitinib in Early Active Axial SpondyloarThritis: a Prospective, Randomized, Double-BLind, PlAcebo-CoNtrolled MulticEntre Study","FASTLANE","Inclusion Criteria:\n\n* Clinical diagnosis of axSpA and fulfilment of the ASAS classification criteria\n* Symptom (back pain) duration for ≤ 2 years, according to the definition of early axial SpA by ASAS.\n* Active disease activity as defined by: BASDAI ≥4 and back pain score (BASDAI question 2) of ≥4 AND objective signs of inflammation evident by osteitis in MRI of SIJ AND\u002FOR elevated serum CRP levels.\n\nExclusion criteria:\n\n* active current infection, severe infections in the last 3 months\n* history of recurrent Herpes zoster or disseminated Herpes simplex\n* immunodeficiency\n* chronic Hepatitis B, C or HIV infection\n* women: pregnant or lactating (have to practice reliable method of contraception)\n* other severe diseases conflicting with a clinical study, contraindications for MRI","ALL","18 Years","45 Years",{"count":78,"type":79},104,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","This is a phase IV, multicentre, randomized, double-blind, placebo-controlled study designed to compare the efficacy and safety of tofacitinib versus placebo (on a background of an NSAID) over 16 weeks of treatment and 4 weeks of safety follow-up in subjects with early active axSpA and inadequate response to at least one NSAID, with objective signs of inflammation.",[85],"Axial Spondyloarthritis","2024-11-22",{"date":88,"type":89},"2024-11-26","ACTUAL",{"date":91,"type":89},"2023-11-10",{"date":93,"type":79},"2026-06",{"name":5,"class":6},1]