- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03863405
Metformin Use in Rheumatoid Arthritis
The Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid Arthritis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Walaa F EL-Baz
- Phone Number: 01112108071
- Email: drwalaaelbaz@yahoo.com
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Al-Zahraa university Hospital
-
Contact:
- Mahmoud M Gharib
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metformin Group
850 mg metformin twice daily for six months in addition to standard therapy
|
metformin 850 mg bid for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2
methotrexate, leflunomide, hydroxychloroquine or sulfasalazine
|
Active Comparator: Control Group
placebo in addition to standard therapy for rheumatoid arthritis
|
methotrexate, leflunomide, hydroxychloroquine or sulfasalazine
oral tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disease activity scale in 28 joints ( DAS-28)
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C reactive protein levels
Time Frame: 6 months
|
blood samples will be withdrawn at baseline and after 3 and 6 months to evaluate serum levels of C reactive protein
|
6 months
|
The HAQ (Health Assessment Score)
Time Frame: 6 months
|
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
|
serum adiponectin level
Time Frame: 6-months
|
blood samples will be withdrawn at baseline and after 3 and 6 months to evaluate serum adiponetin levels using ELISA kits
|
6-months
|
adverse effect incidence
Time Frame: 6 months
|
adverse effect will be reported by patients or their caregivers and recorded by investigator
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 215 (Other Grant/Funding Number: Qatar University International Research Collaboration Co-Fund 2020)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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