A Phase 2 interventional study of Dapagliflozin and Empagliflozin in Rheumatoid Arthritis (RA), sponsored by Al-Azhar University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Al-Azhar University · Phase 2, Interventional, and Treatment
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.
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/European Alliance of Associations for Rheumatology (ACR/EULAR) 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.
2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.
This study's planned enrollment of 90 is close to the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Al-Azhar University is the lead sponsor of 506 studies on the registry; 168 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dapagliflozin 10 mg orally once daily in addition to standard methotrexate therapy for 3 months.
Drug: Dapagliflozin · Drug: Methotrexate
Empagliflozin 10 mg orally once daily in addition to standard methotrexate therapy for 3 months.
Drug: Empagliflozin · Drug: Methotrexate
Standard methotrexate therapy alone for 3 months.
Drug: Methotrexate
Dapagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy.
Empagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy
Standard 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).
Time frame: Baseline to 3 months
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).
Time frame: Baseline to 3 months
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.
Time frame: Baseline to 3 months
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.
Time frame: Baseline to 3 months
Plan to share: No — Individual participant data will not be shared with other researchers.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Al-Azhar University