Metformin Use in Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03863405
• Date of registration: 04/03/2019
• Prospective Registration: No
• Primary sponsor: Ain Shams University
• Public title: Metformin Use in Rheumatoid Arthritis
• Scientific title: The Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid Arthritis
• Date of first enrolment: January 9, 2019
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03863405
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 2

Countries of recruitment

Egypt

Contacts

• Name: Mahmoud M Gharib

• Name: Walaa F EL-Baz

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Conventional DMARDs

Drug: Metformin

Drug: Placebo Oral Tablet

Primary Outcome(s)

disease activity scale in 28 joints ( DAS-28) [Time Frame: 6 months]

Secondary Outcome(s)

The HAQ (Health Assessment Score) [Time Frame: 6 months]

adverse effect incidence [Time Frame: 6 months]

serum adiponectin level [Time Frame: 6-months]

C reactive protein levels [Time Frame: 6 months]

Secondary ID(s)

215

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Future University in Egypt