Rheumatoid Arthritis (RAPhase 1/2NCT07901309
Efficacy and Safety of Dapagliflozin as an Adjunct to Conventional Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis
A Phase 1/2 study testing Dapagliflozin (10mg Tab) in people with Rheumatoid Arthritis (RA, run by Tanta University at 1 site in Egypt.
Trial summary
Rheumatoid arthritis (RA) is a long-standing autoimmune inflammatory disease marked by continuous synovial inflammation, which contributes to progressive cartilage and bone damage, eventually resulting in joint destruction. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis (RA
- What is being tested?
- Dapagliflozin (10mg Tab)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2026to 1 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 23-57 years. Patients meeting the 2010 American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) classification criteria for rheumatoid arthritis (RA).
- Patients with active RA, regardless of disease duration. Patients receiving stable doses of permitted concomitant medications, including: Methotrexate (MTX), Nonsteroidal anti-inflammatory drugs (NSAIDs), Selective cyclooxygenase-2 (COX-2) inhibitors, Acetaminophen, and Low-dose oral corticosteroids.
- Patients stabilized on combination conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for more than four weeks will be eligible for inclusion.
Who cannot join
- Use of intravenous, intra-articular, or intramuscular corticosteroids within four weeks before initiation of the study medication.
- Use of intra-articular sodium hyaluronate within four weeks before initiation of the study medication.
- Use of biologic disease-modifying antirheumatic drugs (bDMARDs) within four weeks before initiation of the study medication.
- Initiation or use of additional csDMARDs within four weeks before initiation of the study medication, except for patients stabilized on combination csDMARD therapy for more than four weeks.
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
Faculty of Medicine, Zagazig University, Zagazig, Egypt
Zagazig, Zagazig, 34518
Mostafa Bahaa, PhD, 01025538337, mbahaa@horus.edu.eg
Mostafa Bahaa, PhD
About this study
Rheumatoid arthritis (RA) is a long-standing autoimmune inflammatory disease marked by continuous synovial inflammation, which contributes to progressive cartilage and bone damage, eventually resulting in joint destruction. Both inherited genetic factors and environmental exposures substantially contribute to the risk of developing the disease. Additionally, several lifestyle and biological factors including diet, cigarette smoking, hormonal influences, alcohol consumption, gut microbiota, infections, and coffee intake have been implicated in the development and progression of RA. Clinically, RA is frequently characterized by morning stiffness, pain involving the shoulder, neck, and pelvic girdle, impaired mobility, and systemic features including fever.
- Conditions
- Rheumatoid Arthritis (RA
- Being tested
- Placebo, Dapagliflozin (10mg Tab)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo will have the same look, and taste of comparative treatment
Dapagliflozin (10mg Tab)Drug
Dapagliflozin has been reported in several studies to possess lots of pharmacological activities, including anti-inflammatory, and apoptotic-modulation.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | control group (n =50) that will receive conventional therapy for RA and placebo Receives: Drug: Placebo |
| Dapagliflozin group | Active comparator | (dapagliflozin group, n = 50) will receive dapagliflozin (10) mg once daily Receives: Drug: Dapagliflozin (10mg Tab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease activity score (DAS-28CRP)
A DAS28 score >5.1 was classified as high disease activity, 3.2 < DAS28 ≤ 5.1 as moderate activity, and DAS28 ≤ 3.2 as low.
activity, and DAS28 <2.6 as remission
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Jul 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 (RAStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901309
- Sponsor's protocol ID
- 78456
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dapagliflozin as an Adjunct to Conventional Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07901309
- Acronym / sponsor ID
- 78456
- Conditions
- Rheumatoid Arthritis (RA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rheumatoid arthritis (RA) is a long-standing autoimmune inflammatory disease marked by continuous synovial inflammation, which contributes to progressive cartilage and bone damage, eventually resulting in joint destruction. Both inherited genetic factors and environmental exposures substantially contribute to the risk of developing the disease. Additionally, several lifestyle and biological factors including diet, cigarette smoking, hormonal influences, alcohol consumption, gut microbiota, infections, and coffee intake have been implicated in the development and progression of RA. Clinically, RA is frequently characterized by morning stiffness, pain involving the shoulder, neck, and pelvic girdle, impaired mobility, and systemic features including fever.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Placebocontrol group (n =50) that will receive conventional therapy for RA and placebo |
| Dapagliflozin group | Active comparator | Drug: Dapagliflozin (10mg Tab)(dapagliflozin group, n = 50) will receive dapagliflozin (10) mg once daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 23-57 years. Patients meeting the 2010 American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) classification criteria for rheumatoid arthritis (RA).
- Patients with active RA, regardless of disease duration. Patients receiving stable doses of permitted concomitant medications, including: Methotrexate (MTX), Nonsteroidal anti-inflammatory drugs (NSAIDs), Selective cyclooxygenase-2 (COX-2) inhibitors, Acetaminophen, and Low-dose oral corticosteroids.
- Patients stabilized on combination conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for more than four weeks will be eligible for inclusion.
Key exclusion criteria (4 listed)
- Use of intravenous, intra-articular, or intramuscular corticosteroids within four weeks before initiation of the study medication.
- Use of intra-articular sodium hyaluronate within four weeks before initiation of the study medication.
- Use of biologic disease-modifying antirheumatic drugs (bDMARDs) within four weeks before initiation of the study medication.
- Initiation or use of additional csDMARDs within four weeks before initiation of the study medication, except for patients stabilized on combination csDMARD therapy for more than four weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo will have the same look, and taste of comparative treatment | Drug | Control group |
| Dapagliflozin (10mg Tab)Dapagliflozin has been reported in several studies to possess lots of pharmacological activities, including anti-inflammatory, and apoptotic-modulation. | Drug | Dapagliflozin group |
Primary outcome
Change in disease activity score (DAS-28CRP)
Time frame: 3 months
A DAS28 score >5.1 was classified as high disease activity, 3.2 < DAS28 ≤ 5.1 as moderate activity, and DAS28 ≤ 3.2 as low. activity, and DAS28 <2.6 as remission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dapagliflozin (10mg Tab) in people with Rheumatoid Arthritis (RA, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Bahaa, PhD (01025538337, mbahaa@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease activity score (DAS-28CRP) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.