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Trial record 79 of 2724 for:    Rheumatoid Arthritis

Metformin Use in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03863405
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
Future University in Egypt
Information provided by (Responsible Party):
Mahmoud Mustafa Mahmoud Gharib, Ain Shams University

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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Metformin Drug: Conventional DMARDs Drug: Placebo Oral Tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: single blinded
Primary Purpose: Treatment
Official Title: The Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid Arthritis
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : January 9, 2020
Estimated Study Completion Date : January 9, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metformin Group
850 mg metformin twice daily for six months in addition to standard therapy
Drug: Metformin
metformin 850 mg bid for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2

Drug: Conventional DMARDs
methotrexate, leflunomide, hydroxychloroquine or sulfasalazine

Active Comparator: Control Group
placebo in addition to standard therapy for rheumatoid arthritis
Drug: Conventional DMARDs
methotrexate, leflunomide, hydroxychloroquine or sulfasalazine

Drug: Placebo Oral Tablet
oral tablet




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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

  2. 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.


  3. 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

  4. adverse effect incidence [ Time Frame: 6 months ]
    adverse effect will be reported by patients or their caregivers and recorded by investigator



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863405


Contacts
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Contact: Walaa F EL-Baz 01112108071 drwalaaelbaz@yahoo.com

Locations
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Egypt
Al-Zahraa University Hospital Recruiting
Cairo, Egypt
Contact: Mahmoud M Gharib         
Sponsors and Collaborators
Ain Shams University
Future University in Egypt

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Responsible Party: Mahmoud Mustafa Mahmoud Gharib, Principal investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03863405     History of Changes
Other Study ID Numbers: 215
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs