[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635602":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":37,"locations":48,"responsibleParty":70,"collaborators":42,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":42,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":50,"whyStopped":42,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Shaikh Zayed Hospital, Lahore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tofacitinib and statins","EXPERIMENTAL","In one group tofacitinib (5 mg twice daily) and statins (atorvastatin 20 mg daily) will be added to the treatment regimen of the patients.",[13],"Drug: Tofacitinib 5 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"control group TNF inhibitor","ACTIVE_COMPARATOR","o In control group TNF inhibitor will be added to the treatment regimen of the patients as part of standard treatment",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Tofacitinib 5 MG","* In one group tofacitinib (5 mg twice daily) and statins (atorvastatin 20 mg daily) will be added to the treatment regimen of the patients.\n* In control group TNF inhibitor will be added to the treatment regimen of the patients as part of standard treatment.\n* Patients will be followed up monthly for a period of 6 months.\n* Monthly assessments during follow up will include Lipid profile Total cholesterol, LDL, HDL, triglycerides. DAS-28 score. Recording of any CVD events (MACE). Monitoring of any other related complications.",[9,15],[26],"statins",[28,31,34],{"name":29,"affiliation":5,"role":30},"Masooma Hashmat, FCPS","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":5,"role":33},"Aflak Rasheed, FCPS","STUDY_DIRECTOR",{"name":35,"affiliation":5,"role":36},"Maira Khalil, MBBS","STUDY_CHAIR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Masooma Hashmat, FCPS Rheumatology","CONTACT","+923353053304",null,"masoomahashmat@gmail.com",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Aflak Rasheed, FCPS Rheumatology","+923009476913","aflakrasheed@yahoo.com",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Lahore","Punjab Province","45000","Pakistan","PK",{"type":57,"coordinates":58},"Point",[59,60],74.35071,31.558,{"lat":60,"lon":59},[63,64,66,67,68],{"name":29,"role":40,"phone":41,"phoneExt":42,"email":43},{"name":32,"role":40,"phone":46,"phoneExt":65,"email":47},"Hashmat",{"name":29,"role":30,"phone":42,"phoneExt":42,"email":42},{"name":32,"role":30,"phone":42,"phoneExt":42,"email":42},{"name":35,"role":69,"phone":42,"phoneExt":42,"email":42},"SUB_INVESTIGATOR",{"type":30,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Masooma Hashmat","DR.","100635602","phase-4-major-adverse-cardiovascular-events-mace-in-rheumatoid-arthritis-patient-with-moderate-to-severe-disease-activity-treated-with-tofacitinib-and-statins-vs-tnf-inhibitors-tofstat-clinical-trial-100635602",false,"NCT07554820","Major Adverse Cardiovascular Events (MACE) in Rheumatoid Arthritis Patient With Moderate to Severe Disease Activity Treated With Tofacitinib and Statins vs TNF Inhibitors: TOFSTAT CLINICAL TRIAL","TOFSTAT","Inclusion Criteria:\n\n* • RA diagnosis with moderate to severe disease activity, based on DAS-28 despite on \\> 2 conventional DMARDs.\n\n  * One or more CVD risk factors, such as hypertension, diabetes, smoking, high cholesterol, etc.\n  * Age 50 or older.\n\nExclusion Criteria:\n\n* Known contraindications to statins.\n\n  * History of major adverse CV events (e.g., recent myocardial infarction or stroke).\n  * Pregnancy or breastfeeding.","ALL","50 Years","85 Years",{"count":84,"type":85},120,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","The rationale of our study is to observe the incidence of MACE in RA patients treated with tofacitinib along with statins with one or more cardiovascular disease risks.\n\nPRIMARY OBJECTIVE\n\n* To determine the incidence of MACE in Rheumatoid Arthritis patients with moderate to high disease activity and with one or more cardiovascular disease risks, which are non-responsive to standard conventional DMARDs (cDMARDs) treatment and are prescribed Tofacitinib 5 mg twice daily along with statin 20 mg daily versus TNF Inhibitors.\n* The study aim to compare MACE in RA patients treated with tofacitinib and statin versus TNF inhibitors.",[91,92],"Rheumatoid Arthritis","Major Adverse Cardiac Events",[94],"rheumatoid arthritis, Major adverse cardiac event, tofacitinib","2026-04-21",{"date":97,"type":98},"2026-04-28","ACTUAL",{"date":100,"type":98},"2025-12-06",{"date":102,"type":85},"2026-09-30",{"name":5,"class":6},1]