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Not yet recruitingNCT07901309Updated Oct 28, 2026

Efficacy and Safety of Dapagliflozin as an Adjunct to Conventional Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis

A Phase 1/2 interventional study of Placebo and Dapagliflozin (10mg Tab) in Rheumatoid Arthritis (RA, sponsored by Tanta University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Tanta University · Phase 1/2, Interventional, and Treatment

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 15 studies in Arthritis, Rheumatoid by Tanta University — 11 open to participants now, 11 under way, 3 of them phase 3. Arthritis, Rheumatoid · Tanta University.

Planned enrollment
Largest of 14
100 · median 63
Started
2026
with 4 others
Phase 1/2
Only one
of the 15
Primary completion
2027-06
later than 9 of 10 live
Registered
15th of 15
by date

Among the 15 studies in Arthritis, Rheumatoid by Tanta University, this one has the largest planned enrollment of the 14 interventional ones that give a count, is one of 5 that started in 2026, is the only one in phase 1/2, reaches primary completion later than 9 of the 10 other live ones, and was the 15th registered.

Arthritis, Rheumatoid

3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.

Browse Arthritis, Rheumatoid studies →

Open to participants now

11 of the 15 studies in Arthritis, Rheumatoid by Tanta University are open now, in 1 country. Recruiting first, the newest first:

5 more — sign in →

By country, each count listing its studies:

All 11 open studies →

Where they have run

Who these studies take

Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Arthritis, Rheumatoid by Tanta University, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Rheumatoid Arthritis (RA
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 .

Patients stabilized on combination conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for more than four weeks will be eligible for inclusion.

Exclusion criteria

Exclusion Criteria:

Use of intravenous, intra-articular, or intramuscular 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Control group

    control group (n =50) that will receive conventional therapy for RA and placebo

    Drug: Placebo

  • Active comparator
    Dapagliflozin group

    (dapagliflozin group, n = 50) will receive dapagliflozin (10) mg once daily

    Drug: Dapagliflozin (10mg Tab)

Interventions

  • DrugPlacebo

    Placebo will have the same look, and taste of comparative treatment

  • Dapagliflozin has been reported in several studies to possess lots of pharmacological activities, including anti-inflammatory, and apoptotic-modulation.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

07

Study locations

1 site
  • Faculty of Medicine, Zagazig University, Zagazig, Egypt
    Zagazig, Zagazig 34518, Egypt
    • Mostafa Bahaa, PhD · Contactmbahaa@horus.edu.eg · 01025538337
    • Mostafa Bahaa, PhD · Principal investigator
    • Sarah Mokhtar fouad abd El Wehab Al Marsafy, MSC · Principal investigator
    • Marwa Zaghlol, PhD · Sub investigator
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.

Of 29 phase 1/2 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 26. This study's planned 8 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Oct 28, 2026
StartEst.
Oct 30, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jul 1, 2027
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

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 ↗

09

Registry details

Key details

Study ID
NCT07901309
Lead sponsor
Tanta University
Responsible party
Mostafa Bahaa (Lecturer, Tanta University) — Principal investigator
First posted
Oct 28, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

Mostafa Bahaa, PhD
Contact
mbahaa@horus.edu.eg
01025538337

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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