Rheumatoid Arthritis Clinical Trial
Official title:
The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.
Verified date | October 2022 |
Source | Sadat City University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Metformin, a traditional antidiabetic medication, exerts glucose lowering effects by activating AMP-activated protein kinase (AMPK), a critical enzyme involved in the lipid and glucose metabolism. In addition to the antidiabetic effect, metformin has been shown to inhibit Lipopolysaccharide-Induced Inflammation (LPS)-induced inflammation by suppress NF-κB production, which is also regulated by AMPK. These regulatory effects of AMPK on the inflammation, immune and fibroblast-like synovial cells have prompted the investigation on the effects of metformin on rheumatoid arthritis.
Status | Completed |
Enrollment | 120 |
Est. completion date | February 28, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with active rheumatoid arthritis based on DAS28 score. 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Pharmacy | Shibin Al Kawm | Menoufia |
Lead Sponsor | Collaborator |
---|---|
Sadat City University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ACR 20% improvement criteria (ACR20) response rate | based on tender and swollen joint counts, patient's assessment of pain, patient and physician global assessment of arthritis, Health Assessment Questionnaire Disability Index (HAQ DI), and CRP level | week 12 | |
Primary | ACR50 & ACR70 response rate | based on tender and swollen joint counts, patient's assessment of pain, patient and physician global assessment of arthritis, Health Assessment Questionnaire Disability Index (HAQ DI), and CRP level | week 12 | |
Primary | Disease activity scale in 28 joints (DAS-28) | Scale assessing severity of rheumatoid arthritis based on number of tender, swollen joints, erythrocyte sedimentation rate (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). | week 12 | |
Secondary | the Short Form 36 (SF-36) Health Survey | both the physical component score [PCS] and the mental component score [MCS]) | week 12 | |
Secondary | HAQ-DI (Health Assessment Score- Disability index) | 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 | week 12 | |
Secondary | AMPK expression | AMPK expression in synovium or serum | at baseline and at week 12 | |
Secondary | IGF-IR expression | IGF-IR expression in Blood | at baseline and at week 12 | |
Secondary | TNF-a | Serum level Tumor necrosis factor- alpha (TNF-a) | at baseline and at week 12 | |
Secondary | TGF-Beta1 | Serum level tissue growth factor beta 1 | at baseline and at week 12 | |
Secondary | Inteleukins | Serum levels of Interleukins (IL) IL-17, IL-1ß , IL-6 & IL-10 | at baseline and at week 12 | |
Secondary | CRP | Serum level of C-reactive protein (CRP) | at baseline and at week 12 | |
Secondary | Drug Adverse effects | Adverse effect incidence: adverse effect will be reported by patients or their caregivers and recorded by investigator. | 3 months |
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