Rheumatoid Arthritis
Conditions
Brief summary
Among three MAPK families, paroxetine was found to be able to decrease the phosphorylation of ERK. It was reported that paroxetine attenuates the symptoms of collage induced arthritis rats due to its inhibitory effect on T cell activation and infiltration to synovial tissue via suppression of ERK pathway. This study aimed to evaluate the therapeutic efficacy of paroxetine in rheumatoid arthritis. Paroxetine prevents the joint inflammation which is at the very early stage. paroxetine could inhibit GRK2 with selectivity over other GRKs. Medications developed for maintaining the immunologic equilibrium. such as GRK2 inhibitors, will be the novel trends in RA treatment that could avoid the adverse side effects that are common with current treatment options.
Interventions
DRUGParoxetine
Paroxetine 20 mg tablet plus standard therapy
DRUGPlacebo
Placebo tablet plus standard therapy
Sponsors
Sadat City University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACR 20% improvement criteria (ACR20) response rate | week 12 | 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 |
| ACR50 & ACR70 response rate | week 12 | 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 |
| Disease activity scale in 28 joints (DAS-28) | week 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRP | 12 weeks | Serum level of C-reactive protein (CRP) |
| GRK2 expression | week 12 | GRK2 expression in serum |
| Drug Adverse effects | 12 weeks | Adverse effect incidence: adverse effect will be reported by patients or their caregivers and recorded by investigator. |
| TNF-α | week 12 | Serum level Tumor necrosis factor- alpha (TNF-α) |
| Inteleukins | 12 weeks | Serum levels of Interleukins (IL) IL-17, IL-1β , IL-6 & IL-10 |
Countries
Egypt
Outcome results
None listed