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

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.

Timeline

Start

2024-10-15

Primary completion

2025-03-10

Completion

2025-04-10

Publications

• Background McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011 Dec 8;365(23):2205-19. doi: 10.1056/NEJMra1004965. No abstract available.
• Background Yin H, Liu N, Sigdel KR, Duan L. Role of NLRP3 Inflammasome in Rheumatoid Arthritis. Front Immunol. 2022 Jun 27;13:931690. doi: 10.3389/fimmu.2022.931690. eCollection 2022.
• Background Kalantari E, Zolbanin NM, Ghasemnejad-Berenji M. Protective effects of empagliflozin on methotrexate induced hepatotoxicity in rats. Biomed Pharmacother. 2024 Jan;170:115953. doi: 10.1016/j.biopha.2023.115953. Epub 2023 Dec 7.
• Background Guo Q, Wang Y, Xu D, Nossent J, Pavlos NJ, Xu J. Rheumatoid arthritis: pathological mechanisms and modern pharmacologic therapies. Bone Res. 2018 Apr 27;6:15. doi: 10.1038/s41413-018-0016-9. eCollection 2018.
• Background Quagliariello V, De Laurentiis M, Rea D, Barbieri A, Monti MG, Carbone A, Paccone A, Altucci L, Conte M, Canale ML, Botti G, Maurea N. The SGLT-2 inhibitor empagliflozin improves myocardial strain, reduces cardiac fibrosis and pro-inflammatory cytokines in non-diabetic mice treated with doxorubicin. Cardiovasc Diabetol. 2021 Jul 23;20(1):150. doi: 10.1186/s12933-021-01346-y.
• Background Theofilis P, Sagris M, Oikonomou E, Antonopoulos AS, Siasos G, Tsioufis K, Tousoulis D. Pleiotropic effects of SGLT2 inhibitors and heart failure outcomes. Diabetes Res Clin Pract. 2022 Jun;188:109927. doi: 10.1016/j.diabres.2022.109927. Epub 2022 May 14.
• Background Gagnon KB, Delpire E. Sodium Transporters in Human Health and Disease. Front Physiol. 2021 Feb 25;11:588664. doi: 10.3389/fphys.2020.588664. eCollection 2020.
• Background Kolli VK, Natarajan K, Isaac B, Selvakumar D, Abraham P. Mitochondrial dysfunction and respiratory chain defects in a rodent model of methotrexate-induced enteritis. Hum Exp Toxicol. 2014 Oct;33(10):1051-65. doi: 10.1177/0960327113515503. Epub 2013 Dec 17.

Drugs

Indications