Rheumatoid Arthritis (RA)Phase 2NCT07864688
Evaluation of Dapagliflozin and Empagliflozin as Adjunctive Therapy to Methotrexate in Patients With Rheumatoid Arthritis
A Phase 2 study testing Dapagliflozin, Empagliflozin and Methotrexate in people with Rheumatoid Arthritis (RA), run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Dapagliflozin, Empagliflozin and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2026to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Type 1 diabetes mellitus or history of diabetic ketoacidosis (DKA).
- Known hypersensitivity to dapagliflozin, empagliflozin, or any of their components.
- Participation in another clinical trial within the previous 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Al-Zahraa University Hospital
Cairo, Cairo Governorate
Enas A. El-Shorbagy, M.Sc. in Clinical Pharmacy, +0201123339227, enas-elshorbagy@eru.edu.eg
Enas A. El-Shorbagy, M.Sc. in Clinical Pharmacy
About this study
Official title: Evaluation of Dapagliflozin and Empagliflozin as Adjunctive Therapy to Methotrexate in Patients With Rheumatoid Arthritis: A Randomized Controlled Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Dapagliflozin, Empagliflozin, Methotrexate
- Keywords
- Dapagliflozin, Empagliflozin, Methotrexate, SGLT2 Inhibitors, DAS28-CRP, MMP-3
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy.
EmpagliflozinDrug
Empagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy
MethotrexateDrug
Standard methotrexate therapy for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin + Methotrexate | Experimental | Dapagliflozin 10 mg orally once daily in addition to standard methotrexate therapy for 3 months. Receives: Drug: Dapagliflozin; Drug: Methotrexate |
| Empagliflozin + Methotrexate | Experimental | Empagliflozin 10 mg orally once daily in addition to standard methotrexate therapy for 3 months. Receives: Drug: Empagliflozin; Drug: Methotrexate |
| Methotrexate Alone | Active comparator | Standard methotrexate therapy alone for 3 months. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 3 months
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Ahmed Mohamed Elshorbagy, Egyptian Russian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864688
- Sponsor's protocol ID
- AZU-RA-SGLT2-2026-001
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.