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

NCT06641128 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Effect of Empagliflozin in RA
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis (RA); Methotrexate Induced Nephrotoxicity; Methotrexate Adverse Reaction

Keywords

Rheumatoid Arthritis; Methotrexate side effect; empagliflozin role in RA

Outcome Measures

Primary Outcomes (1)

• calculation of DAS28-CRP score for measure disease activity

  this is a score for measure of disease activity in RA ; 2.6 mean RA is in remission 2.6 to 3.2 mean low level of disease activity More than 3.2 mean active disease that may require change in medication More than 5.1 mean very active disease that requires careful monitoring and adjustment to medication

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (1)

• measurement of the levels of Interleukin-1β and Superoxide dismutase

  From enrollment to the end of treatment at 3 months

Study Arms (2)

MTX SC or IM - Empa tab

ACTIVE COMPARATOR

IM or SC Methotrexate plus Empa tablets 25 mg once dailyf or 3 months.

Drug: MTX SC or IM; Drug: Empagliflozin 25mg tab

MTX SC or IM - placebo tab

PLACEBO COMPARATOR

IM or SC Methotrexate plus placebo tablet once daily for 3 months.

Drug: MTX SC or IM

Interventions

MTX SC or IM DRUG

IM or SC Methotrexate

MTX SC or IM - Empa tab; MTX SC or IM - placebo tab

Empagliflozin 25mg tab DRUG

Empa tablets 25 mg once daily for 3 months.

MTX SC or IM - Empa tab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

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

Al Mansurah, 35511, Egypt

Location

Related Publications (8)

• 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.

  PMID: 22150039 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.

  PMID: 35833125 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.

  PMID: 38064971 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.

  PMID: 29736302 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.

  PMID: 34301253 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.

  PMID: 35577035 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.

  PMID: 33716756 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.

  PMID: 24347301 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Nehad W Karam, Bachelor of clinical Pharmacy

CONTACT

+20 1284918959; nehadwaleedkaram@gmail.com

Eman Ibrahim Elberri, Lecturer of clinical pharmacy

CONTACT

+20 1003592593; eman.elberri@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist and Master's degree student

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion: March 10, 2025
• Study Completion: April 10, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)