Evaluating Paroxetine for Rheumatoid Arthritis Treatment
The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients.
This study is testing if adding the medication paroxetine to the usual treatment for rheumatoid arthritis can help patients feel better and manage their symptoms more effectively.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 23 Years to 57 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Damietta, New Damietta) |
| Trial ID | NCT06231745 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of paroxetine as an adjunctive treatment for patients with rheumatoid arthritis (RA) who are already receiving methotrexate. The study aims to address the limitations of current RA therapies by potentially enhancing treatment responses and improving patient outcomes. Participants will be monitored for their response to paroxetine alongside their existing medications, focusing on both tolerability and effectiveness in managing RA symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 23-57 who meet the ACR-EULAR criteria for active rheumatoid arthritis and are currently on methotrexate.
Not a fit: Patients with diabetes, severe anemia, or those who have had adverse reactions to paroxetine will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients with rheumatoid arthritis, improving their quality of life.
How similar studies have performed: While the use of paroxetine in rheumatoid arthritis is not widely tested, similar studies exploring adjunctive therapies have shown promise in improving treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 23-57 years fulfilling 2010 American College of Rheumatology - European League against Rheumatism (ACR-EULAR) classification criteria for RA (12) and had active inflammatory RA with no limit in disease duration. * Patients received MTX, nonsteroidal anti-inflammatory drugs, selective cyclooxygenase-2 inhibitors, acetaminophen, and low dose of oral corticosteroids will be allowed to enroll the trial * Intravenous, intra-articular or intramuscular corticosteroids; intra-articular hyaluronate sodium; biological DMARDs; and other DMARDs will not be permitted less than 4 weeks before the first dose of paroxetine. Exclusion Criteria: * patients refusing to give informed consent, diabetes, congestive heart failure, previous adverse reaction to paroxetine, oral prednisolone greater than 10 mg/day, receiving biological DMARDs, severe anemia, active infection, pregnancy or lactation, and clinically significant renal or hepatic disease.
Where this trial is running
Damietta, New Damietta
- Mostafa Bahaa — Damietta, New Damietta, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.