[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659583":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":30,"studyPopulation":23,"armGroups":31,"interventions":49,"overallOfficials":23,"centralContacts":63,"locations":69,"responsibleParty":98,"collaborators":23,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":23,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":23,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":125,"whyStopped":23,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Al-Azhar University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) from baseline to 3 months","Change in disease activity assessed using the Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) from baseline to 3 months. The DAS28-CRP score ranges from 0 to 9.4, with higher scores indicating greater rheumatoid arthritis disease activity (worse outcome).","Baseline to 3 months",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Change in serum matrix metalloproteinase-3 (MMP-3) concentration from baseline to 3 months","Change in serum matrix metalloproteinase-3 (MMP-3) concentration from baseline to 3 months. Serum matrix metalloproteinase-3 (MMP-3) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA).",{"measure":18,"description":19,"timeFrame":12},"Number and percentage of participants experiencing at least one adverse drug reaction during the 3-month treatment period","Number and percentage of participants experiencing at least one adverse drug reaction during the 3-month treatment period. Adverse drug reactions will be assessed based on clinical assessment and participant reporting.",{"measure":21,"description":22,"timeFrame":12},"Number and percentage of participants with treatment discontinuation due to adverse drug reactions","Number and percentage of participants who permanently discontinue study treatment because of an adverse drug reaction during the 3-month treatment period.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE","This is a prospective, randomized, controlled, parallel-group, open-label clinical trial that will be conducted at the Rheumatology Outpatient Clinic of Al-Zahraa University Hospital, Cairo. The study will include adult patients aged 18 to 65 years with rheumatoid arthritis diagnosed according to the 2010 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR\u002FEULAR) classification criteria, who have been receiving stable methotrexate treatment for at least 12 weeks and have active rheumatoid arthritis despite methotrexate therapy. A total of 90 participants will be enrolled and randomly allocated in a 1:1:1 ratio into three groups, with 30 participants in each group. Group I will receive dapagliflozin 10 mg once daily in addition to standard methotrexate therapy for 3 months. Group II will receive empagliflozin 10 mg once daily in addition to standard methotrexate therapy for 3 months. Group III will receive standard methotrexate therapy alone for 3 months. Clinical and laboratory assessments will be performed at baseline and after 3 months. Disease activity will be assessed using the Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP). Laboratory assessments will include serum matrix metalloproteinase-3 (MMP-3), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), complete blood count, alanine aminotransferase, aspartate aminotransferase, serum creatinine, and estimated glomerular filtration rate. Safety and tolerability will also be assessed throughout the study. The primary outcome is the change in DAS28-CRP from baseline to 3 months. Secondary outcomes include the change in serum MMP-3 concentration from baseline to 3 months, assessment of adverse drug reactions, and treatment discontinuation due to adverse drug reactions.",[32,39,44],{"label":33,"type":34,"description":35,"interventionNames":36},"Dapagliflozin + Methotrexate","EXPERIMENTAL","Dapagliflozin 10 mg orally once daily in addition to standard methotrexate therapy for 3 months.",[37,38],"Drug: Dapagliflozin","Drug: Methotrexate",{"label":40,"type":34,"description":41,"interventionNames":42},"Empagliflozin + Methotrexate","Empagliflozin 10 mg orally once daily in addition to standard methotrexate therapy for 3 months.",[43,38],"Drug: Empagliflozin",{"label":45,"type":46,"description":47,"interventionNames":48},"Methotrexate Alone","ACTIVE_COMPARATOR","Standard methotrexate therapy alone for 3 months.",[38],[50,55,59],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":23},"DRUG","Dapagliflozin","Dapagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy.",[33],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":23},"Empagliflozin","Empagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy",[40],{"type":51,"name":60,"description":61,"armGroupLabels":62,"otherNames":23},"Methotrexate","Standard methotrexate therapy for 3 months.",[33,40,45],[64],{"name":65,"role":66,"phone":67,"phoneExt":23,"email":68},"Enas A. El-Shorbagy, M.Sc. in Clinical Pharmacy","CONTACT","+201123339227","enas-elshorbagy@eru.edu.eg",[70],{"facility":71,"status":23,"city":72,"state":73,"zip":23,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Al-Zahraa University Hospital","Cairo","Cairo Governorate","Egypt","EG",{"type":77,"coordinates":78},"Point",[79,80],31.24967,30.06263,{"lat":80,"lon":79},[83,85,87,90,92,94,96],{"name":65,"role":66,"phone":84,"phoneExt":23,"email":68},"+0201123339227",{"name":65,"role":86,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"name":88,"role":89,"phone":23,"phoneExt":23,"email":23},"Zeinab AlKasaby Mahmoud Zalat, Prof. Dr.","SUB_INVESTIGATOR",{"name":91,"role":89,"phone":23,"phoneExt":23,"email":23},"Hesham M. El-Refeay, Prof. Dr.",{"name":93,"role":89,"phone":23,"phoneExt":23,"email":23},"Adel A. Elbeialy, Prof. Dr.",{"name":95,"role":89,"phone":23,"phoneExt":23,"email":23},"Mohamed Fathy El-Shafie, Assistant Professor",{"name":97,"role":89,"phone":23,"phoneExt":23,"email":23},"Dina Mohamed Ibrahim, Lecturer",{"type":86,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":101,"oldNameTitle":23,"oldOrganization":23},"Enas Ahmed Mohamed Elshorbagy","Teaching Assistant in Pharmacy Practice and Clinical Pharmacy","Egyptian Russian University","100659583","phase-2-evaluation-of-dapagliflozin-and-empagliflozin-as-adjunctive-therapy-to-methotrexate-in-patients-with-rheumatoid-arthritis-100659583",false,"NCT07864688","Evaluation of Dapagliflozin and Empagliflozin as Adjunctive Therapy to Methotrexate in Patients With Rheumatoid Arthritis","Evaluation of Dapagliflozin and Empagliflozin as Adjunctive Therapy to Methotrexate in Patients With Rheumatoid Arthritis: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Patients aged 18-65 years.\n* Diagnosed with rheumatoid arthritis according to the 2010 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR\u002FEULAR) classification criteria.\n* Receiving stable methotrexate therapy for at least 12 weeks.\n* Active rheumatoid arthritis (DAS28-CRP \\>3.2) despite methotrexate therapy.\n* Willing to participate, able to provide informed consent, and able to comply with study requirements.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Current use of any sodium-glucose cotransporter 2 (SGLT2) inhibitor.\n* Severe renal or hepatic impairment.\n* Active or recurrent urinary or genital infections.\n* Type 1 diabetes mellitus or history of diabetic ketoacidosis (DKA).\n* Known hypersensitivity to dapagliflozin, empagliflozin, or any of their components.\n* Participation in another clinical trial within the previous 3 months.","ALL","18 Years","65 Years",{"count":113,"type":114},90,"ESTIMATED","INTERVENTIONAL",[117],"PHASE2","This study aims to evaluate the efficacy and safety of dapagliflozin and empagliflozin as adjunctive therapies to methotrexate in patients with rheumatoid arthritis who have active disease despite stable methotrexate treatment. The study will compare three groups: methotrexate plus dapagliflozin 10 mg once daily, methotrexate plus empagliflozin 10 mg once daily, and methotrexate alone. Participants will be followed for 3 months. The primary outcome is the change in Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) from baseline to 3 months. Secondary outcomes include changes in serum matrix metalloproteinase-3 (MMP-3), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and assessment of safety and tolerability.",[120],"Rheumatoid Arthritis (RA)",[52,56,60,122,123,124],"SGLT2 Inhibitors","DAS28-CRP","MMP-3","NOT_YET_RECRUITING","2026-10-02",{"date":128,"type":129},"2026-10-08","ACTUAL",{"date":131,"type":114},"2026-12",{"date":133,"type":114},"2027-12",{"name":5,"class":6},1]