Paroxetine Safety and Efficacy in Rheumatoid Arthritis

Last updated: April 5, 2025
Sponsor: Mostafa Bahaa
Overall Status: Active - Recruiting

Phase

3

Condition

Rheumatoid Arthritis

Joint Injuries

Dermatomyositis (Connective Tissue Disease)

Treatment

Paroxetine

Methotrexate

Clinical Study ID

NCT06231745
314879
  • Ages 23-57
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Aged 23-57 years fulfilling 2010 American College of Rheumatology - European Leagueagainst Rheumatism (ACR-EULAR) classification criteria for RA (12) and had activeinflammatory RA with no limit in disease duration.

  • Patients received MTX, nonsteroidal anti-inflammatory drugs, selectivecyclooxygenase-2 inhibitors, acetaminophen, and low dose of oral corticosteroidswill be allowed to enroll the trial

  • Intravenous, intra-articular or intramuscular corticosteroids; intra-articularhyaluronate sodium; biological DMARDs; and other DMARDs will not be permitted lessthan 4 weeks before the first dose of paroxetine.

Exclusion

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 orlactation, and clinically significant renal or hepatic disease.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Paroxetine
Phase: 3
Study Start date:
January 31, 2024
Estimated Completion Date:
February 20, 2026

Connect with a study center

  • Mostafa Bahaa

    Damietta, New Damietta 34518
    Egypt

    Active - Recruiting

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