Paroxetine Safety and Efficacy in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231745
• Other study ID #: 314879
• Status: Recruiting
• Phase: Phase 3
• Start date: January 31, 2024
• Est. completion date: February 20, 2026

Study information

• Verified date: January 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 20, 2026
• Est. primary completion date: February 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 57 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Methotrexate
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.
• Paroxetine
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).

Locations

Country	Name	City	State
Egypt	Mostafa Bahaa	Damietta	New Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Mostafa Bahaa

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy end point will be the change in the 28-joints disease activity score (DAS28).	A DAS28 value of greater than 5.1 indicates high disease activity. The values of 3.2 < DAS28 = 5.1 and DAS28 = 3.2 are indicative of moderate and low disease activities, respectively. If DAS28 value is less than 2.6, the patients may be considered to be in remission phase	3 months