Evaluation of Dapagliflozin and Empagliflozin as Adjunctive Therapy to Methotrexate in Patients With Rheumatoid Arthritis

NCT ID
NCT07864688
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
Al-Azhar University
Conditions
Rheumatoid Arthritis (RA)

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: Evaluation of Dapagliflozin and Empagliflozin as Adjunctive Therapy to Methotrexate in Patients With Rheumatoid Arthritis: A Randomized Controlled Clinical Trial

Enrollment: 90 participants (Estimated).

What is being studied

  • Intervention: Aminopterin
  • Intervention: dapagliflozin
  • Drug: Dapagliflozin
  • Intervention: empagliflozin
  • Drug: Empagliflozin
  • Intervention: Heterocyclic Compounds
  • Intervention: Heterocyclic Compounds, 2-Ring
  • Intervention: Heterocyclic Compounds, Fused-Ring
  • Drug: Methotrexate
  • Intervention: Methotrexate
  • Intervention: Pteridines
  • Intervention: Pterins

Who may be eligible

Ages
18 Years to 65 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Egypt

  • Cairo Governorate, Egypt: 1

Sample of listed locations

  • Al-Zahraa University Hospital — Cairo, Cairo Governorate, Egypt — Site recruitment status not specified in the registry data

Study details

Start date
December 1, 2026
Primary completion date
December 1, 2027
Completion date
December 1, 2027
First posted
October 8, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07864688
Registry last updated
October 8, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT07864688 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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