RecruitingPhase 3NCT06231745

Paroxetine Safety and Efficacy in Rheumatoid Arthritis

The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients.

Sponsor

Mostafa Bahaa

Enrollment

100 participants

Start Date

Jan 31, 2024

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

Summary

Rheumatoid arthritis (RA) is a systemic chronic auto-inflammatory disorder which imposes a remarkable burden of morbidity and mortality on global health. The complex interaction between genetics, environment, and immunological response contribute to RA pathogenesis. Current treatment comprises conventional disease-modifying anti-rheumatic drugs (DMARDs) followed by biological DMARDs, if necessary, to achieve low disease activity or remission. Therapeutics used in RA had limitations in tolerability, access, and response duration and magnitude. Consequently, implementation of safe adjunctive treatment for RA is urgently needed to boost the therapeutic response.

Eligibility

Min Age: 23 YearsMax Age: 57 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether paroxetine (an antidepressant that also has anti-inflammatory properties) is safe and effective for people with rheumatoid arthritis (RA) — a condition where the immune system attacks the joints, causing pain and swelling. **You may be eligible if...** - You are between 23 and 57 years old - You have been diagnosed with active rheumatoid arthritis - You are currently taking methotrexate, anti-inflammatory drugs, or low-dose oral steroids for your RA **You may NOT be eligible if...** - You have diabetes, heart failure, severe anemia, or significant kidney or liver disease - You have had a bad reaction to paroxetine before - You are pregnant or breastfeeding - You are taking high-dose steroids (more than 10 mg prednisolone per day) or biologic RA medications - You have an active infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethotrexate

Methotrexate (MTX) is an anti-metabolite most commonly used in chemotherapy and immunosuppressant in auto-immune diseases. This activity describes the indications, action, and contraindications for Methotrexate as a valuable agent in treating a wide variety of diseases.

DRUGParoxetine

Paroxetine is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It's often used to treat depression, and sometimes obsessive compulsive disorder (OCD), panic attacks, anxiety or post-traumatic stress disorder (PTSD).