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Evaluation of Dapagliflozin and Empagliflozin as Adjunctive Therapy to Methotrexate in Patients With Rheumatoid Arthritis
Sponsor: Al-Azhar University
Summary
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.
Official title: Evaluation of Dapagliflozin and Empagliflozin as Adjunctive Therapy to Methotrexate in Patients With Rheumatoid Arthritis: A Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-12
Completion Date
2027-12
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Dapagliflozin
Dapagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy.
Empagliflozin
Empagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy
Methotrexate
Standard methotrexate therapy for 3 months.
Locations (1)
Al-Zahraa University Hospital
Cairo, Cairo Governorate, Egypt