Fexofenadine in Patients With Active Rheumatoid Arthritis

Last updated: July 28, 2025
Sponsor: October 6 University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Musculoskeletal Diseases

Joint Injuries

Arthritis And Arthritic Pain

Treatment

Placebo

Fexofenadine

Clinical Study ID

NCT05264025
FMBSUREC/08052022/Ismaeel
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Rheumatoid arthritis (RA) is an inflammatory autoimmune polyarthritis affecting ∼1% of the world population, resulting in the loss of joint function and progressive structural damage in affected joints. Fexofenadine has been widely used to treat various allergic diseases, like allergic rhinitis, conjunctivitis and chronic idiopathic urticaria. the molecular mechanisms underlying fexofenadine mediated inhibition of TNF-α signalling

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Moderate to severe RA (disease activity score-28 joints: DAS-28 > 3.2) wererecruited.

  • Age between 18 - 60 years having active disease according to the diagnosis of anexperienced rheumatologist, being under treatment with disease-modifyinganti-rheumatic drugs (DMARDs), not receiving cytokine inhibitors

  • Signing informed consent and willingness of the participant to accept randomizationto any assigned treatment arm.

Exclusion

Exclusion Criteria:

  • History of biological DMARDS.

  • History/presence of acute heart disease, liver and kidney diseases, COPD

  • Intolerance or allergy to fexofenadine or methotrexate

  • Alcohol abuse

  • Any changes in using medication (changing the dosage or type of medicines

  • Receive hormone replacement therapy, warfarin, and other anticoagulants

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
June 01, 2022
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Beni-Suef Hospital

    Banī Suwayf,
    Egypt

    Active - Recruiting

  • Faculty of Medicine - Beni Suef Hospital

    Banī Suwayf,
    Egypt

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.