Rheumatoid Arthritis (RA
Conditions
Brief summary
Rheumatoid arthritis (RA) is a long-standing autoimmune inflammatory disease marked by continuous synovial inflammation, which contributes to progressive cartilage and bone damage, eventually resulting in joint destruction. Both inherited genetic factors and environmental exposures substantially contribute to the risk of developing the disease. Additionally, several lifestyle and biological factors including diet, cigarette smoking, hormonal influences, alcohol consumption, gut microbiota, infections, and coffee intake have been implicated in the development and progression of RA. Clinically, RA is frequently characterized by morning stiffness, pain involving the shoulder, neck, and pelvic girdle, impaired mobility, and systemic features including fever.
Interventions
DRUGPlacebo
Placebo will have the same look, and taste of comparative treatment
Dapagliflozin has been reported in several studies to possess lots of pharmacological activities, including anti-inflammatory, and apoptotic-modulation.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Adults aged 23-57 years. Patients meeting the 2010 American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) classification criteria for rheumatoid arthritis (RA). Patients with active RA, regardless of disease duration. Patients receiving stable doses of permitted concomitant medications, including: Methotrexate (MTX), Nonsteroidal anti-inflammatory drugs (NSAIDs), Selective cyclooxygenase-2 (COX-2) inhibitors, Acetaminophen, and Low-dose oral corticosteroids. Patients stabilized on combination conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for more than four weeks will be eligible for inclusion.
Exclusion criteria
Use of intravenous, intra-articular, or intramuscular corticosteroids within four weeks before initiation of the study medication. Use of intra-articular sodium hyaluronate within four weeks before initiation of the study medication. Use of biologic disease-modifying antirheumatic drugs (bDMARDs) within four weeks before initiation of the study medication. Initiation or use of additional csDMARDs within four weeks before initiation of the study medication, except for patients stabilized on combination csDMARD therapy for more than four weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in disease activity score (DAS-28CRP) | 3 months | A DAS28 score \>5.1 was classified as high disease activity, 3.2 \< DAS28 ≤ 5.1 as moderate activity, and DAS28 ≤ 3.2 as low. activity, and DAS28 \<2.6 as remission |
Countries
Egypt
Contacts
CONTACTMostafa Bahaa, PhD
Outcome results
None listed