Metformin Use in Rheumatoid Arthritis

NCT03863405 | Unknown Phase 2

• 1 other identifier: 215
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• C reactive protein levels

  6 months

• The HAQ (Health Assessment Score)

  6 months

• serum adiponectin level

  6-months

• adverse effect incidence

  6 months

Study Arms (2)

Metformin Group

EXPERIMENTAL

850 mg metformin twice daily for six months in addition to standard therapy

Drug: Metformin; Drug: Conventional DMARDs

Control Group

ACTIVE COMPARATOR

placebo in addition to standard therapy for rheumatoid arthritis

Drug: Conventional DMARDs; Drug: Placebo Oral Tablet

Interventions

Metformin DRUG

metformin 850 mg bid for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2

Metformin Group

Conventional DMARDs DRUG

methotrexate, leflunomide, hydroxychloroquine or sulfasalazine

Control Group; Metformin Group

Placebo Oral Tablet DRUG

oral tablet

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead
• Future University in Egypt: collaborator

Study Sites (1)

Al-Zahraa University Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Metformin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Walaa F EL-Baz

CONTACT

01112108071; drwalaaelbaz@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 5, 2019
• Study Start: January 9, 2019
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)