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

Launched by TANTA UNIVERSITY · Oct 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether a medication called empagliflozin can help people with rheumatoid arthritis (RA) who are also being treated with methotrexate, a common medication for RA. The goal is to see if empagliflozin can provide additional benefits and protect against any harmful effects that methotrexate might cause, particularly on the kidneys. The study will involve 44 participants who will be divided into two groups: one group will receive methotrexate plus a placebo (a pill that contains no active medicine), and the other group will receive methotrexate along with empagliflozin for three months.

To take part in the study, participants need to be between 18 and 60 years old and have active rheumatoid arthritis. However, there are some important criteria for exclusion, such as having kidney or liver diseases, certain blood disorders, or being pregnant. Throughout the trial, participants will be monitored closely through weekly phone calls and monthly visits to check for any side effects and ensure they are following the treatment plan. This study is currently not recruiting participants, but it aims to provide valuable information on the safety and effectiveness of empagliflozin for those living with rheumatoid arthritis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with active rheumatoid arthritis (not in remission) according to 28 joints disease activity score (DAS-28)
• • Age range between 18 and 60 years old.
• • Both sexes.
• • Body mass index (BMI), age, disease activity, and disease duration matched patients.
• Exclusion Criteria:
• • Patients with renal or hepatic diseases (chronic liver disease, liver cirrhosis, alcoholic hepatitis, or chronic alcoholism).
• • Patients receiving biological DMARDs during 4 weeks before the first dose of Empa.
• • Patients with hypersensitivity to study medications.
• • Patients using antioxidants except Empa.
• • Pregnant and lactating females.
• • Pre-existing blood disorders, such as bone marrow hypoplasia, leukopenia, thrombocytopenia, or significant anemia.
• • Patient with HIV/AIDS, blood dyscrasias, or radiotherapy.