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NOT YET RECRUITING
NCT06641128
PHASE4

The Possible Efficacy and Protective Effect of Empagliflozin in Rheumatoid Arthritis Patients Treated with Methotrexate

Sponsor: Tanta University

View on ClinicalTrials.gov

Summary

The primary aim of this clinical trial is to Evaluate the Possible Efficacy and Protective Effect of Empagliflozin in Rheumatoid Arthritis Patients Treated with Methotrexate. Methodology: This is a randomized, double blind placebo controlled parallel study that will be conducted on 44 patients with active rheumatoid arthritis. Group1 (placebo group; n=22) which will receive IM or SC Methotrexate plus placebo tablet once daily for 3 months. Group2 (Empa group; n=22) which will receive IM or SC Methotrexate plus Empa tablets 25 mg once daily for 3 months. Duration: 3 months Monitoring: Participants will be followed up by weekly telephone calls and monthly direct meeting at scheduled visits to assess their adherence and to report any drug related adverse effects. In summary, this clinical trial is designed to determine if empagliflozin is a safe and effective treatment for Rheumatoid Arthritis Patients Treated with Methotrexate by comparing its effects to a placebo and closely monitoring participants throughout the study.

Official title: Clinical Study Evaluating the Possible Efficacy and Protective Effect of Empagliflozin in Rheumatoid Arthritis Patients Treated with Methotrexate

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2024-10-15

Completion Date

2025-04-10

Last Updated

2024-10-17

Healthy Volunteers

No

Interventions

DRUG

MTX SC or IM

IM or SC Methotrexate

DRUG

Empagliflozin 25mg tab

Empa tablets 25 mg once daily for 3 months.

Locations (1)

Outpatient Clinic of Internal Medicine, Rheumatology and Immunology Department, Mansoura University Hospital

Al Mansurah, Egypt