[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524740":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":42,"responsibleParty":58,"collaborators":61,"id":65,"slug":24,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":24,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"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,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Charité Universitätsmedizin Berlin","RECRUITING","Berlin","Germany",{"type":49,"coordinates":50},"Point",[51,52],13.41053,52.52437,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":57,"phoneExt":24,"email":41},"Dr. Valeria Rios Rodriguez","004930450514582",{"type":29,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Denis Poddubnyy","Prof. Dr. med.",[62],{"name":63,"class":64},"Pfizer","INDUSTRY","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":76,"type":77},104,"ESTIMATED","INTERVENTIONAL",[80],"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.",[83],"Axial Spondyloarthritis","2024-11-22",{"date":86,"type":87},"2024-11-26","ACTUAL",{"date":89,"type":87},"2023-11-10",{"date":91,"type":77},"2026-06",{"name":5,"class":6},1]