Trials Sponsors Conditions Drugs Pricing

Conditions

Rheumatoid Arthritis (RA)

Keywords

DapagliflozinEmpagliflozinMethotrexateSGLT2 InhibitorsDAS28-CRPMMP-3

Outcome Measures

Primary Outcomes (1)

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).
Baseline to 3 months

Secondary Outcomes (3)

Change in serum matrix metalloproteinase-3 (MMP-3) concentration from baseline to 3 months
Baseline to 3 months
Number and percentage of participants experiencing at least one adverse drug reaction during the 3-month treatment period
Baseline to 3 months
Number and percentage of participants with treatment discontinuation due to adverse drug reactions
Baseline to 3 months

Study Arms (3)

Dapagliflozin + Methotrexate

EXPERIMENTAL

Dapagliflozin 10 mg orally once daily in addition to standard methotrexate therapy for 3 months.

Drug: DapagliflozinDrug: Methotrexate

Empagliflozin + Methotrexate

EXPERIMENTAL

Empagliflozin 10 mg orally once daily in addition to standard methotrexate therapy for 3 months.

Drug: EmpagliflozinDrug: Methotrexate

Methotrexate Alone

ACTIVE COMPARATOR

Interventions

DapagliflozinDrug

Dapagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy.

Dapagliflozin + Methotrexate

EmpagliflozinDrug

Empagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy

Empagliflozin + Methotrexate

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Al-Azhar University
Otherlead

Study Sites (1)

Al-Zahraa University Hospital

Cairo, Cairo Governorate, Egypt

Enas A. El-Shorbagy, M.Sc. in Clinical PharmacyCONTACT+0201123339227 enas-elshorbagy@eru.edu.eg

Enas A. El-Shorbagy, M.Sc. in Clinical PharmacyPRINCIPAL INVESTIGATOR

Zeinab AlKasaby Mahmoud Zalat, Prof. Dr.SUB INVESTIGATOR

Hesham M. El-Refeay, Prof. Dr.SUB INVESTIGATOR

Adel A. Elbeialy, Prof. Dr.SUB INVESTIGATOR

Mohamed Fathy El-Shafie, Assistant ProfessorSUB INVESTIGATOR

Dina Mohamed Ibrahim, LecturerSUB INVESTIGATOR

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

dapagliflozinempagliflozinMethotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin

Central Study Contacts

Enas A. El-Shorbagy, M.Sc. in Clinical Pharmacy

CONTACT

+201123339227 enas-elshorbagy@eru.edu.eg

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Teaching Assistant in Pharmacy Practice and Clinical Pharmacy

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 8, 2026

Study Start

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

December 2027

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Dapagliflozin + Methotrexate

Empagliflozin + Methotrexate

Methotrexate Alone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Dapagliflozin + Methotrexate

Empagliflozin + Methotrexate

Methotrexate Alone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations