NCT07864688Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 28 Sept 2026
- Start date
- Dec 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Al-Azhar University
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07864688
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From Dec 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial within the previous 3 months.
Other illness
- Severe renal or hepatic impairment.
- Active or recurrent urinary or genital infections.
- Type 1 diabetes mellitus or history of diabetic ketoacidosis (DKA).
- Known hypersensitivity to dapagliflozin, empagliflozin, or any of their components.
Lab values
- Current use of any sodium-glucose cotransporter 2 (SGLT2) inhibitor.
Other
- Pregnancy or lactation.
Who the study is looking for
- 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.
- Willing to participate, able to provide informed consent, and able to comply with study requirements.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Al-Zahraa University Hospital Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.