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.
Patients aged 18-65 years.
Diagnosed with rheumatoid arthritis according to the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria.
Receiving stable methotrexate therapy for at least 12 weeks.
Active rheumatoid arthritis (DAS28-CRP >3.2) despite methotrexate therapy.
Pregnancy or lactation.
Current use of any sodium-glucose cotransporter 2 (SGLT2) inhibitor.
Severe renal or hepatic impairment.
Active or recurrent urinary or genital infections.
Parallel
Dapagliflozin
DrugDapagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy.
Empagliflozin
DrugEmpagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy
Methotrexate
DrugStandard methotrexate therapy for 3 months.
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).
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).
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.
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.
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Al-Azhar University
Lead sponsor
Egyptian Russian University
Sponsor institution
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