Paroxetine Safety and Efficacy in Rheumatoid Arthritis

NCT ID: NCT06231745

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2026-02-20

Brief 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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control group

group one (control group): 50 patients will receive the conventional DMARDs therapy (methotrexate 7.5 mg IM once weekly) plus placebo tablets

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

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.

Comparative group

50 patients will receive the conventional DMARDs therapy (methotrexate 7.5 mg IM once weekly) plus 20 mg paroxetine daily

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

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

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: DRUG

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).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 57 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mostafa Bahaa

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Bahaa

Teaching assisstant

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Mostafa Bahaa

Damietta, New Damietta, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Mostafa Bahaa, PhD

Role: primary

mbahaa@horus.edu.eg

0201025538337

Other Identifiers

314879

Identifier Type: -

Identifier Source: org_study_id