Metformin Use in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

The Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03863405
• Other study ID #: 215
• Status: Recruiting
• Phase: Phase 2
• Start date: January 9, 2019
• Est. completion date: January 9, 2020

Study information

• Verified date: May 2019
• Source: Ain Shams University
• Contact: Walaa F EL-Baz
• Phone: 01112108071
• Email: drwalaaelbaz[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 this effect is independent of its hypoglycemic effect.

Animal studies showed that metformin decreased serum C-reactive protein (CRP) level in atherogenic rabbits and decreased proinflammatory cytokines (interleukin (IL)-1β, IL-6 and tumor necrosis factor (TNF-α) in obese mice .

Moreover, metformin also suppressed osteoclastogenesis ; this may partially result from decreased expression of inflammatory cytokines that promote osteoclastogenesis in the arthritic joint.

The objective of this study is to evaluate the efficacy and safety of addition of metformin to standard disease modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 9, 2020
• Est. primary completion date: January 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Metformin
metformin 850 mg bid for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2
• Conventional DMARDs
methotrexate, leflunomide, hydroxychloroquine or sulfasalazine
• Placebo Oral Tablet
oral tablet

Locations

Country	Name	City	State
Egypt	Al-Zahraa University Hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease activity scale in 28 joints ( DAS-28)	scale assessing severity of rheumatoid arthritis based on number of tender , swollen joints , ESR levels ,and patient self-assessment of his condition (global health assessment) . Whereas "28" describes the number of different joints including in the measurement :proximal interphalangeal joints (10 joints),metacarpophalangeal joints (10),wrists (2),elbows (2),shoulders (2),knees (2).; DAS28 values range from 2 to 10 while higher values mean a higher disease activity. A DAS-28 value < 2.6 corresponds to remission,value between 2.6 and 3.2 corresponds to a low disease activity, value between 3.2 and 5.1 corresponds to a moderate disease activity, and DAS28 value >5.1 corresponds to a high disease activity.	6 months
Secondary	C reactive protein levels	blood samples will be withdrawn at baseline and after 3 and 6 months to evaluate serum levels of C reactive protein	6 months
Secondary	The HAQ (Health Assessment Score)	HAQ-DI (Health Assessment Score- Disability index), in which patients are asked to rate their capacity to perform 20 activities of daily living (ADL). Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, The Standard Disability Index (DI) calculated as the sum of the scores for various subscales divided by the number of subscales responded to, and results in a score between 0 and 3.Whereas scores can be interpreted as: From 0 to 1: mild difficulties to moderate disability, 2: moderate, 3: severe to very severe disability.	6 months
Secondary	serum adiponectin level	blood samples will be withdrawn at baseline and after 3 and 6 months to evaluate serum adiponetin levels using ELISA kits	6-months
Secondary	adverse effect incidence	adverse effect will be reported by patients or their caregivers and recorded by investigator	6 months