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

Sponsor
Tanta University
Study ID
NCT06641128
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • MTX SC or IM — DRUG
    IM or SC Methotrexate
  • Empagliflozin 25mg tab — DRUG
    Empa tablets 25 mg once daily for 3 months.

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
Oct 2024
Primary completion
Mar 10, 2025
Completion
Apr 10, 2025

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: MTX SC or IM - Empa tab
    IM or SC Methotrexate plus Empa tablets 25 mg once dailyf or 3 months.
  • Placebo Comparator: MTX SC or IM - placebo tab
    IM or SC Methotrexate plus placebo tablet once daily for 3 months.

Primary Outcome Measure

calculation of DAS28-CRP score for measure disease activity [ Time Frame: From enrollment to the end of treatment at 3 months ]

Central Contacts

Related Studies