Back to resultsMetformin Use in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Metformin
Conventional DMARDs
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility 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.
Sites / Locations
- Al-Zahraa University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Metformin Group
Control Group
Arm Description
850 mg metformin twice daily for six months in addition to standard therapy
placebo in addition to standard therapy for rheumatoid arthritis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
serum adiponectin level
blood samples will be withdrawn at baseline and after 3 and 6 months to evaluate serum adiponetin levels using ELISA kits
adverse effect incidence
adverse effect will be reported by patients or their caregivers and recorded by investigator
Full Information
NCT ID
NCT03863405
First Posted
March 4, 2019
Last Updated
May 23, 2019
Sponsor
Ain Shams University
Collaborators
Future University in Egypt
1. Study Identification
Unique Protocol Identification Number
NCT03863405
Brief Title
Metformin Use in Rheumatoid Arthritis
Official Title
The Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
January 9, 2020 (Anticipated)
Study Completion Date
January 9, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
Future University in Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
single blinded
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metformin Group
Arm Type
Experimental
Arm Description
850 mg metformin twice daily for six months in addition to standard therapy
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
placebo in addition to standard therapy for rheumatoid arthritis
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
metformin 850 mg bid for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2
Intervention Type
Drug
Intervention Name(s)
Conventional DMARDs
Intervention Description
methotrexate, leflunomide, hydroxychloroquine or sulfasalazine
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
oral tablet
Primary Outcome Measure Information:
Title
disease activity scale in 28 joints ( DAS-28)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
C reactive protein levels
Description
blood samples will be withdrawn at baseline and after 3 and 6 months to evaluate serum levels of C reactive protein
Time Frame
6 months
Title
The HAQ (Health Assessment Score)
Description
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.
Time Frame
6 months
Title
serum adiponectin level
Description
blood samples will be withdrawn at baseline and after 3 and 6 months to evaluate serum adiponetin levels using ELISA kits
Time Frame
6-months
Title
adverse effect incidence
Description
adverse effect will be reported by patients or their caregivers and recorded by investigator
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Walaa F EL-Baz
Phone
01112108071
Email
drwalaaelbaz@yahoo.com
Facility Information:
Facility Name
Al-Zahraa University Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud M Gharib
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Metformin Use in Rheumatoid Arthritis
We'll reach out to this number within 24 hrs