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

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 17, 2024 (before its estimated March 10, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary endpoint revised Interventions: MTX SC or IM (Drug), MTX SC or IM and Empagliflozin 25mg tab (Drug) to Empagliflozin 25mg tab (Drug), MTX SC or IM (Drug) · Secondary endpoint revised · Study description shortened, about 198 wordsv2 Show 3 more changesShow less
    • Interventions: MTX SC or IM (Drug), MTX SC or IM and Empagliflozin 25mg tab (Drug) to Empagliflozin 25mg tab (Drug), MTX SC or IM (Drug)
    • Secondary endpoint revised
    • Study description shortened, about 198 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06641128
Lead Sponsor Tanta University
Conditions Rheumatoid Arthritis (RA), Methotrexate Induced Nephrotoxicity, Methotrexate Adverse Reaction
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov