Rheumatoid ArthritisPhase 2NCT03863405
Metformin Use in Rheumatoid Arthritis
A Phase 2 study testing Metformin and Conventional DMARDs in people with Rheumatoid Arthritis, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Metformin and Conventional DMARDs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jan 2019to 9 Jan 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Zahraa University Hospital
Cairo
Mahmoud M Gharib
About this study
Official title: 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.
Read more
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
- Being tested
- Metformin, Conventional DMARDs, Placebo Oral Tablet
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
metformin 850 mg bid for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2
Conventional DMARDsDrug
methotrexate, leflunomide, hydroxychloroquine or sulfasalazine
Placebo Oral TabletDrug
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Metformin Group | Experimental | 850 mg metformin twice daily for six months in addition to standard therapy Receives: Drug: Metformin; Drug: Conventional DMARDs |
| Control Group | Active comparator | placebo in addition to standard therapy for rheumatoid arthritis Receives: Drug: Conventional DMARDs; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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
Measured: 6 months
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.
Measured: 6 months
serum adiponectin level
blood samples will be withdrawn at baseline and after 3 and 6 months to evaluate serum adiponetin levels using ELISA kits
Measured: 6-months
adverse effect incidence
adverse effect will be reported by patients or their caregivers and recorded by investigator
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start9 Jan 2019
- Primary completion9 Jan 2020 (estimated)
- Study completion9 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Future University in Egypt
- Responsible party
- Principal investigator, Mahmoud Mustafa Mahmoud Gharib, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863405
- Sponsor's protocol ID
- 215
- Status last verified
- May 2019
- First submitted
- 4 Mar 2019
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03863405
- Acronym / sponsor ID
- 215
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Future University in Egypt
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 9 Jan 2020 (estimated)
- Study completion
- 9 Jan 2020 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin Group | Experimental | Drug: Metformin, Drug: Conventional DMARDs850 mg metformin twice daily for six months in addition to standard therapy |
| Control Group | Active comparator | Drug: Conventional DMARDs, Drug: Placebo Oral Tabletplacebo in addition to standard therapy for rheumatoid arthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metforminmetformin 850 mg bid for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2 | Drug | Metformin Group |
| Conventional DMARDsmethotrexate, leflunomide, hydroxychloroquine or sulfasalazine | Drug | Control Group, Metformin Group |
| Placebo Oral Tabletoral tablet | Drug | Control Group |
Primary outcome
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.
4 secondary outcomes
C reactive protein levels
Time frame: 6 months
The HAQ (Health Assessment Score)
Time frame: 6 months
serum adiponectin level
Time frame: 6-months
adverse effect incidence
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin and Conventional DMARDs in people with Rheumatoid Arthritis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walaa F EL-Baz (01112108071, drwalaaelbaz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease activity scale in 28 joints ( DAS-28) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.