Status:
UNKNOWN
Metformin Use in Rheumatoid Arthritis
Lead Sponsor:
Ain Shams University
Collaborating Sponsors:
Future University in Egypt
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Metformin has been used clinically for over 50 years, as a glucose lowering agent. Direct and indirect anti-inflammatory effects of metformin have been reported in animal and clinical studies, and th...
Eligibility Criteria
Inclusion
- Patients older than 18 years (of both sexes) diagnosed with rheumatoid arthritis according to ACR / EULAR 2010 criteria .
- Patients with moderate to high disease activity (DAS - 28 . score greater than 3.2)
- Patients received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.
Exclusion
- Known hypersensitivity to metformin.
- Patients who have a prior diagnosis with diabetes mellitus.
- Patients receive metformin for any other indications.
- Patients with congestive heart failure.
- Patients with a history of myocardial infarction.
- Patients with severe anemia.
- Patients with active infections or other inflammatory diseases.
- Patients receiving biological therapy.
- Pregnancy or lactation.
- Patients with impaired liver functions.
- Patients with impaired kidney functions (serum creatinine concentrations ≥1.5 and ≥1.4 mg/dL in males and females respectively).
- Patients with malignancies.
Key Trial Info
Start Date :
January 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 9 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03863405
Start Date
January 9 2019
End Date
January 9 2020
Last Update
May 28 2019
Active Locations (1)
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1
Al-Zahraa University Hospital
Cairo, Egypt